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                                                            Go PLR Content Marketing Cocos (Keeling) Islands
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                                                                    <h2 class="date-header">
                                                                        <span>
                   Monday, 8 October 2012
                                                                        </span>
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                                                                                    <a href="https://articlesdirectorynorfolkisland.blogspot.com/2012/10/pletal-50-mg-tablets.html">
                                                                                        Pletal 50 mg tablets
                                                                                    </a>
                                                                                </h3>
                                                                                <div class="post-header">
                                                                                    <div class="post-header-line-1">
                                                                                    </div>
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                                                                                    <div class="contentBox">
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            1. Name Of The Medicinal Product
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pletal 50 mg tablets
                                                                                            <br>
                                                                                        </p>
                                                                                        <h2>
                                                                                        </h2>
                                                                                        <h2>
                                                                                            <br>
                                                                                            2. Qualitative And Quantitative Composition
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            One tablet contains 50 mg of cilostazol.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            For a full list of excipients, see section 6.1.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            3. Pharmaceutical Form
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Tablet
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            White, round, flat faced tablets debossed with &ldquo;OG31&rdquo; on one side.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            4. Clinical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.1 Therapeutic Indications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pletal is indicated for the improvement of the maximal and pain-free walking distances in patients with intermittent claudication, who do not have rest pain and who do not have evidence of peripheral tissue necrosis (peripheral arterial disease Fontaine stage II).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.2 Posology And Method Of Administration
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The recommended dosage of cilostazol is 100 mg twice a day. Cilostazol should be taken 30 minutes before or two hours after breakfast and the evening meal. Taking cilostazol with food has been shown to increase the maximum plasma concentrations (C
                                                                                            <sub>
                                                                                                max
                                                                                            </sub>
                                                                                            ) of cilostazol, which may be associated with an increased incidence of adverse effects.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Treatment for 16-24 weeks can result in a significant improvement in walking distance. Some benefit may be observed following treatment for 4-12 weeks.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The physician should consider other treatment options if cilostazol is ineffective after six months.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            The elderly
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There are no special dosage requirements for the elderly.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Children
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Safety and efficacy in children have not been established.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Renal impairment
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No dose adjustment is necessary in patients with a creatinine clearance of&gt;25 ml/min. Cilostazol is contraindicated in patients with a creatinine clearance of
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Hepatic impairment
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No dosage adjustment is necessary in patients with mild hepatic disease. There are no data in patients with moderate or severe hepatic impairment. Since cilostazol is extensively metabolised by hepatic enzymes, it is contraindicated in patients with moderate or severe hepatic impairment.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.3 Contraindications
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            &bull; Known hypersensitivity to cilostazol or to any of the excipients
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            &bull; Severe renal impairment: creatinine clearance of
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            &bull; Moderate or severe hepatic impairment
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            &bull; Congestive heart failure
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            &bull; Pregnancy
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            &bull; Patients with any known predisposition to bleeding (e.g. active peptic ulceration, recent (within six months) haemorrhagic stroke, proliferative diabetic retinopathy, poorly controlled hypertension)
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            &bull; Patients with any history of ventricular tachycardia, ventricular fibrillation or multifocal ventricular ectopics, whether or not adequately treated, and in patients with prolongation of the QTc interval
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.4 Special Warnings And Precautions For Use
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Patients should be warned to report any episode of bleeding or easy bruising whilst on therapy. In case of retinal bleeding administration of cilostazol should be stopped. Refer to Sections 4.3
                                                                                            <i>
                                                                                                Contraindications
                                                                                            </i>
                                                                                            and 4.5
                                                                                            <i>
                                                                                                Interactions with other medicinal products and other forms of interaction
                                                                                            </i>
                                                                                            for further advice on bleeding.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Due to cilostazol's platelet aggregation inhibitory effect it is possible that an increased bleeding risk occurs in combination with surgery (including minor invasive measurements like tooth extraction). If a patient is to undergo elective surgery and anti-platelet effect is not necessary, cilostazol should be stopped 5 days prior to surgery.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There have been rare or very rare reports of haematological abnormalities including thrombocytopenia, leucopenia, agranulocytosis, pancytopenia and aplastic anaemia (see section 4.8). Most patients recovered on discontinuation of cilostazol. However, some cases of pancytopenia and aplastic anaemia had a fatal outcome.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In addition to reporting episodes of bleeding and easy bruising, patients should be warned to promptly report any other signs which might also suggest the early development of blood dyscrasia such as pyrexia and sore throat. A full blood count should be performed if infection is suspected or there is any other clinical evidence of blood dyscrasia. Cilostazol should be discontinued promptly if there is clinical or laboratory evidence of haematological abnormalities.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Caution is advised when cilostazol is co-administered with inhibitors or inducers of CYP3A4 and CYP2C19 or with CYP3A4 substrates. See section 4.5 for further information.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Caution should be exercised when prescribing cilostazol for patients with atrial or ventricular ectopy and patients with atrial fibrillation or flutter.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Caution is needed when co-administering cilostazol with any other agent which has the potential to reduce blood pressure due to the possibility that there may be an additive hypotensive effect with a reflex tachycardia. Refer also to Section 4.8.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Caution should be exercised when co-administering cilostazol with any other agents that inhibit platelet aggregation. Refer to section 4.5
                                                                                            <i>
                                                                                                Interactions with other medicinal products and other forms of interaction.
                                                                                            </i>
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Inhibitors of platelet aggregation
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cilostazol is a PDE III inhibitor with anti-platelet activity. In a clinical study in healthy subjects, cilostazol given 150mg b.i.d. for five days did not result in prolongation of bleeding time.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Aspirin
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Short term (
                                                                                            <i>
                                                                                                ex vivo
                                                                                            </i>
                                                                                            platelet aggregation when compared to aspirin alone.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There were no apparent trends toward a greater incidence of haemorrhagic adverse effects in patients taking cilostazol and aspirin compared to patients taking placebo and equivalent doses of aspirin.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Clopidogrel and other antiplatelet drugs
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Concomitant administration of cilostazol and clopidogrel did not have any effect on platelet count, prothrombin time (PT) or activated partial thromboplastin time (aPTT). All healthy subjects in the study had a prolongation of bleeding time on clopidogrel alone and concomitant administration with cilostazol did not result in a significant additional effect on bleeding time. Caution is advised when co-administering cilostazol with any drug that inhibits platelet aggregation. Consideration should be given to monitoring the bleeding time at intervals. Special attention should be paid to patients who are receiving multiple anti-platelet therapies.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Oral Anticoagulants like warfarin
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In a single-dose clinical study, no inhibition of the metabolism of warfarin or an effect on the coagulation parameters (PT, aPTT, bleeding time) was observed. However, caution is advised in patients receiving both cilostazol and any anticoagulant agent, and frequent monitoring is required to reduce the possibility of bleeding.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Cytochrome P-450 (CYP) enzyme inhibitors
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cilostazol is extensively metabolised by CYP enzymes, particularly CYP3A4 and CYP2C19 and to a lesser extent CYP1A2.The dehydro metabolite, which has 4-7 times the potency of cilostazol in inhibiting platelet aggregation, appears to be formed primarily via CYP3A4. The 4`-trans-hydroxy metabolite, with potency one-fifth that of cilostazol, appears to be formed primarily via CYP2C19. Therefore, drugs inhibiting CYP3A4 (e.g., some macrolides, azole antifungals, protease inhibitors) or CYP2C19 (like proton pump inhibitors, PPIs) increase the total pharmacological activity by 32 and 42%, respectively and could have the potential to enhance the undesirable effects of cilostazol. A dose reduction to cilostazol 50 mg b.i.d. could be considered based on the individual clinical and tolerance response.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Administration of 100 mg cilostazol on the seventh day of erythromycin (a moderate inhibitor of CYP3A4) 500 mg t.i.d. resulted in an increase in the AUC of cilostazol by 74%, accompanied by a 24% decrease in AUC of the dehydro metabolite but with notable increases in AUC of the 4`-trans-hydroxy metabolite.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Co-administration of single doses of ketoconazole (a strong inhibitor of CYP3A4) 400 mg and cilostazol 100 mg resulted in a 117% increase in the AUC of cilostazol, accompanied by a 15% decrease in the AUC of the dehydro metabolite and a 87% increase in the AUC of the 4`-trans-hydroxymetabolite, which finally increases the total pharmacological activity by 32% as compared to cilostazol alone.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Administration of 100 mg cilostazol b.i.d. with diltiazem (an inhibitor of CYP3A4) 180 mg once daily resulted in an increase in the AUC of cilostazol by 44%. Co-administration did not affect exposure to the dehydro metabolite but increased by 40% the AUC of the 4`-trans-hydroxy metabolite. In patients in clinical trials, concomitant use with diltiazem was shown to increase the AUC of cilostazol by 53%.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Administration of a single dose of 100 mg cilostazol with 240 ml grapefruit juice (an inhibitor of intestinal CYP3A4) did not have a notable effect on the pharmacokinetics of cilostazol.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Administration of a single dose of 100 mg cilostazol on the seventh day of omeprazole (an inhibitor of CYP2C19) 40 mg once daily increased the AUC of cilostazol by 26%, accompanied by a 69% increase in the AUC of the dehydro metabolite and a decrease of 31% in the AUC of the 4`-trans hydroxy metabolite, which finally increases the total pharmacological activity by 42% as compared to cilostazol alone.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Cytochrome P-450 enzyme substrates
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cilostazol has been shown to increase the AUC of lovastatin (sensitive substrate for CYP3A4) and its &beta;-hydroxy acid by 70%. Caution is advised when cilostazol is co-administered with CYP3A4 substrates with a narrow therapeutic index (e.g., cisapride, halofantrine, pimozide, ergot derivates). Caution is advised in case of co-administration with simvastatin.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Cytochrome P-450 enzyme inducers
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The effect of CYP3A4 and CYP2C19 inducers (such as carbamazepin, phenytoin, rifampicin and St. John's wort) on cilostazol pharmacokinetics has not been evaluated. The antiplatelet effect may theoretically be altered and should be carefully monitored when cilostazol is co-administered with CYP3A4 and CYP2C19 inducers.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In clinical trials, smoking (which induces CYP1A2) decreased cilostazol plasma concentrations by 18%.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.6 Pregnancy And Lactation
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Pregnancy
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There are no adequate data in the use of cilostazol in pregnant women. Studies in animals have shown reproductive toxicity (see Section 5.3). The potential risk for humans is unknown. Pletal should not be used during pregnancy.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p style="text-decoration: underline">
                                                                                            <br>
                                                                                            Lactation
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The transfer of cilostazol to breast milk has been reported in animal studies. The excretion of cilostazol in human milk is unknown. Due to the potential harmful effect in the newborn child breast fed by a treated mother, the use of Pletal is not recommended during breast feeding.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.7 Effects On Ability To Drive And Use Machines
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cilostazol may cause dizziness and patients should be warned to exercise caution before they drive or operate machinery.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.8 Undesirable Effects
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The most commonly reported adverse reactions in clinical trials were headache (in&gt; 30%), diarrhoea and abnormal stools (in&gt;15% each). These reactions were usually of mild to moderate intensity and were sometimes alleviated by reducing the dose.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Adverse reactions reported in clinical trials and in the post-marketing period are included in the table below.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The frequencies correspond with: Very common (
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Common (
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Uncommon (
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Rare (
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Very rare ( &lt;1/10,000), not known (cannot be estimated from the
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The frequencies of reactions observed in the post-marketing period is considered unknown (cannot be estimated from the available data).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Blood and the lymphatic system disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Ecchymosis
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Anaemia
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Rare
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Bleeding time prolonged, thrombocythaemia
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Unknown
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Bleeding tendency, thrombocytopenia, granulocytopenia, agranulocytosis, leukopenia, pancytopenia, aplastic anaemia
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Immune system disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Allergic reaction
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Metabolism and nutrition disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Oedema (peripheral, face)
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Hyperglycaemia, Diabetes mellitus
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Unknown
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Anorexia
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Psychiatric disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Anxiety
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Nervous system disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Very common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Headache
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Dizziness
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Insomnia, abnormal dreams
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Unknown
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Paresis, hypoaesthesia
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Eye disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Unknown
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Conjunctivitis
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Ear and labyrinth disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Unknown
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Tinnitus
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Cardiac disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Palpitation, tachycardia, angina pectoris, arrhythmia, ventricular extrasystoles
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Myocardial infarction, atrial fibrillation, congestive heart failure, supraventricular tachycardia, ventricular tachycardia, syncope
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Vascular disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Eye haemorrhage, epistaxis, gastrointestinal haemorrhage, haemorrhage unspecified, orthostatic hypotension
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Unknown
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Hot flushes, hypertension, hypotension, cerebral haemorrhage, pulmonary haemorrhage, muscle haemorrhage, respiratory tract haemorrhage, subcutaneous haemorrhage
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Respiratory, thoracic and mediastinal disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Rhinitis, pharyngitis
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Dyspnoea, pneumonia, cough
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Unknown
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Interstitial pneumonia
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Gastrointestinal disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Very common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Diarrhoea, abnormal faeces
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Nausea and vomiting, dyspepsia, flatulence, abdominal pain
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Gastritis
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Hepato-biliary disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Unknown
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Hepatitis, hepatic function abnormal, jaundice
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Skin and subcutaneous tissue disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Rash, pruritus
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Unknown
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Eczema, skin eruptions, Stevens-Johnson syndrome, toxic epidermal necrolysis, urticaria
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Musculoskeletal, connective tissue and bone disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Myalgia
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Renal and urinary disorders
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Rare
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Renal failure, renal impairment
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Unknown
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Haematuria, pollakiuria
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            General disorders and administration site conditions
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            &nbsp;
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Common
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Chest pain, asthenia
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uncommon
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Chills
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Unknown
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Pyrexia, malaise, pain
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        &nbsp;
                                                                                                    </td>
                                                                                                </tr>
                                                                                                <tr style="vertical-align: top; ">
                                                                                                    <td style="width: 197px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Investigations
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 132px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Unknown
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                    <td style="width: 262px; ">
                                                                                                        <br>
                                                                                                        <p>
                                                                                                            <br>
                                                                                                            Uric acid level increased, blood urea increased, blood creatinine increased
                                                                                                            <br>
                                                                                                        </p>
                                                                                                        <br>
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <p>
                                                                                            <br>
                                                                                            An increase in the incidence of palpitation and peripheral oedema was observed when cilostazol was combined with other vasodilators that cause reflex tachycardia e.g. dihydropyridine calcium channel blockers.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The only adverse event resulting in discontinuation of therapy in
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cilostazol
                                                                                            <i>
                                                                                                per se
                                                                                            </i>
                                                                                            may carry an increased risk of bleeding and this risk may be potentiated by co-administration with any other agent with such potential.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The risk of intraocular bleeding may be higher in patients with diabetes.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            4.9 Overdose
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Information on acute overdose in humans is limited. The signs and symptoms can be anticipated to be severe headache, diarrhoea, tachycardia and possibly cardiac arrhythmias.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Patients should be observed and given supportive treatment. The stomach should be emptied by induced vomiting or gastric lavage, as appropriate.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            5. Pharmacological Properties
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.1 Pharmacodynamic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitor excl. heparin.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            ATC code: B01A C
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            From data generated in nine placebo-controlled studies (where 1,634 patients were exposed to cilostazol), it has been demonstrated that cilostazol improves exercise capacity as judged by changes in Absolute Claudication Distance (ACD, or maximal walking distance) and Initial Claudication Distance (ICD
                                                                                            <b>
                                                                                                ,
                                                                                            </b>
                                                                                            or pain-free walking distance) upon treadmill testing. Following 24 weeks treatment, cilostazol 100 mg b.i.d. increases in mean ACD ranged from 60.4 - 129.1 metres, whilst mean ICD increases ranged from 47.3 - 93.6 metres.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            A meta-analysis based on weighted mean differences across the nine studies indicated that there was a significant absolute overall post-baseline improvement of 42 m in maximal walking distance (ACD) for cilostazol 100 mg b.i.d. over the improvement seen under placebo. This corresponds to a relative improvement of 100% over placebo. This effect appeared lower in diabetics than in non-diabetics.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Animal studies have shown cilostazol to have vasodilator effects and this has been demonstrated in small studies in man where ankle blood flow was measured by strain gauge plethysmography. Cilostazol also inhibits smooth muscle cell proliferation in rat and human smooth muscle cells
                                                                                            <i>
                                                                                                in vitro
                                                                                            </i>
                                                                                            , and inhibits the platelet release reaction of platelet-derived growth factor and PF-4 in human platelets.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Studies in animals and in man (
                                                                                            <i>
                                                                                                in vivo
                                                                                            </i>
                                                                                            and
                                                                                            <i>
                                                                                                ex vivo
                                                                                            </i>
                                                                                            ) have shown that cilostazol causes reversible inhibition of platelet aggregation. The inhibition is effective against a range of aggregants (including shear stress, arachidonic acid, collagen, ADP and adrenaline); in man the inhibition lasts for up to 12 hours, and on cessation of administration of cilostazol recovery of aggregation occurred within 48-96 hours, without rebound hyperaggregability. Effects on circulating plasma lipids have been examined in patients taking Pletal. After 12 weeks, as compared to placebo, Pletal 100 mg b.i.d. produced a reduction in triglycerides of 0.33 mmol/L (15%) and an increase in HDL-cholesterol of 0.10mmol/L (10%).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            A randomized, double-blind, placebo-controlled Phase IV study was conducted to assess the long-term effects of cilostazol, with focus on mortality and safety. In total, 1,439 patients with intermittent claudication and no heart failure have been treated with cilostazol or placebo for up to three years. With respect to mortality, the observed 36-month Kaplan-Meier event rate for deaths on study drug with a median time on study drug of 18 months was 5.6% (95%CI of 2.8 to 8.4%) on cilostazol and 6.8% (95% CI of 1.9 to 11.5%) on placebo. Long-term treatment with cilostazol did not raise safety concerns.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.2 Pharmacokinetic Properties
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Following multiple doses of cilostazol 100 mg twice daily in patients with peripheral vascular disease, steady state is achieved within 4 days.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The C
                                                                                            <sub>
                                                                                                max
                                                                                            </sub>
                                                                                            of cilostazol and its primary circulating metabolites increase less than proportionally with increasing doses. However, the AUC for cilostazol and its metabolites increase approximately proportionately with dose.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The apparent elimination half-life of cilostazol is 10.5 hours. There are two major metabolites, a dehydro-cilostazol and a 4'-trans-hydroxy cilostazol, both of which have similar apparent half-lives. The dehydro metabolite is 4-7 times as active a platelet anti-aggregant as the parent compound and the 4'-trans-hydroxy metabolite is one fifth as active. Plasma concentrations (as measured by AUC) of the dehydro and 4`-trans-hydroxy metabolites are ~41% and ~12% of cilostazol concentrations.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cilostazol is eliminated predominantly by metabolism and subsequent urinary excretion of metabolites. The primary isoenzymes involved in its metabolism are cytochrome P-450 CYP3A4, to a lesser extent, CYP2C19, and to an even lesser extent CYP1A2.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The primary route of elimination is urinary (74%) with the remainder excreted in the faeces. No measurable amount of unchanged cilostazol is excreted in the urine, and less than 2% of the dose is excreted as the dehydro-cilostazol metabolite. Approximately 30% of the dose is excreted in the urine as the 4'-trans-hydroxy metabolite. The remainder is excreted as metabolites, none of which exceed 5% of the total excreted.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cilostazol is 95-98% protein bound, predominantly to albumin. The dehydro metabolite and 4'-trans-hydroxy metabolite are 97.4% and 66% protein bound respectively.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There is no evidence that cilostazol induces hepatic microsomal enzymes.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            The pharmacokinetics of cilostazol and its metabolites were not significantly affected by age or gender in healthy subjects aged between 50-80 years.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In subjects with severe renal impairment, the free fraction of cilostazol was 27% higher and both C
                                                                                            <sub>
                                                                                                max
                                                                                            </sub>
                                                                                            and AUC were 29% and 39% lower respectively than in subjects with normal renal function. The C
                                                                                            <sub>
                                                                                                max
                                                                                            </sub>
                                                                                            and AUC of the dehydro metabolite were 41% and 47% lower respectively in the severely renally impaired subjects compared to subjects with normal renal function. The C
                                                                                            <sub>
                                                                                                max
                                                                                            </sub>
                                                                                            and AUC of 4'-trans-hydroxy cilostazol were 173% and 209% greater in subjects with severe renal impairment. The drug should not be administered to patients with a creatinine clearance &lt;25ml/min (see Section 4.3).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            There are no data in patients with moderate to severe hepatic impairment and since cilostazol is extensively metabolised by hepatic enzymes, the drug should not be used in such patients (see Section 4.3).
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            5.3 Preclinical Safety Data
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cilostazol and several of its metabolites are phosphodiesterase III inhibitors which suppress cyclic AMP degradation, resulting in increased cAMP in a variety of tissues including platelets and blood vessels. As with other positive inotropic and vasodilator agents, cilostazol produced cardiovascular lesions in dogs. Such lesions were not seen in rats or monkeys and are considered species specific. Investigation of QTc in dogs and monkeys showed no prolongation after administration of cilostazol or its metabolites.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Mutagenicity studies were negative in bacterial gene mutation, bacterial DNA repair, mammalian cell gene mutation and mouse
                                                                                            <i>
                                                                                                in vivo
                                                                                            </i>
                                                                                            bone marrow chromosomal aberrations. In
                                                                                            <i>
                                                                                                in vitro
                                                                                            </i>
                                                                                            tests on Chinese ovary hamster cells cilostazol produced a weak but significant increase in chromosome aberration frequency. No unusual neoplastic outcomes were observed in two-year carcinogenicity studies in rats at oral (dietary) doses up to 500 mg/kg/day, and in mice at doses up to 1000 mg/kg/day.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            In rats dosed during pregnancy, foetal weights were decreased. In addition, an increase in foetuses with external, visceral and skeletal abnormalities was noted at high dose levels. At lower dose levels, retardations of ossification were observed. Exposure in late pregnancy resulted in an increased incidence of stillbirths and lower offspring weights. An increased incidence of retardation of ossification of the sternum was observed in rabbits. As there is no experience of cilostazol use in human pregnancy, it should not be used in women who are pregnant.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            6. Pharmaceutical Particulars
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.1 List Of Excipients
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Maize starch, microcrystalline cellulose, carmellose calcium, hypromellose and magnesium stearate.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.2 Incompatibilities
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Not applicable.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.3 Shelf Life
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            3 years.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.4 Special Precautions For Storage
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            This medicinal product does not require any special storage conditions.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.5 Nature And Contents Of Container
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Cartons containing 14, 20, 28, 30, 50, 56, 98, 100, 112 and 168 tablets as well as hospital packs with 70 (5x14) tablets packed in PVC/Aluminium blisters.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Not all pack sizes may be marketed.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            <br>
                                                                                            6.6 Special Precautions For Disposal And Other Handling
                                                                                            <br>
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            No special requirements.
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            7. Marketing Authorisation Holder
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Otsuka Pharmaceutical Europe Ltd
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Hunton House
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Highbridge Business Park
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Oxford Road
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Uxbridge
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            Middlesex, UB8 1HU
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            UK
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            8. Marketing Authorisation Number(S)
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            PL 11515/0002
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            9. Date Of First Authorisation/Renewal Of The Authorisation
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            21 March 2000 / 20 March 2005
                                                                                            <br>
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            <br>
                                                                                            10. Date Of Revision Of The Text
                                                                                            <br>
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            <br>
                                                                                            November 2008
                                                                                            <br>
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                                                                            Saturday, 6 October 2012
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                                                                                    <a href="https://articlesdirectorynorfolkisland.blogspot.com/2012/10/nexiclon-xr.html">
                                                                                        Nexiclon XR
                                                                                    </a>
                                                                                </h3>
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                                                                                        <br>
                                                                                        <b>
                                                                                            Pronunciation:
                                                                                        </b>
                                                                                        KLOE-ni-deen
                                                                                        <br>
                                                                                        <b>
                                                                                            Generic Name:
                                                                                        </b>
                                                                                        <span>
                                                                                            Clonidine
                                                                                        </span>
                                                                                        <br>
                                                                                        <b>
                                                                                            Brand Name:
                                                                                        </b>
                                                                                        Nexiclon XR
                                                                                        <br>
                                                                                        <br>
                                                                                        <a id="treatment">
                                                                                        </a>
                                                                                        <br>
                                                                                        <h2>
                                                                                            Nexiclon XR is used for:
                                                                                        </h2>
                                                                                        <p>
                                                                                            Treating high blood pressure. It may be used alone or with other medicines. It may also be used for other conditions as determined by your doctor.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Nexiclon XR is an alpha agonist. It works by relaxing blood vessels and decreasing heart rate, which lowers blood pressure.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            Do NOT use Nexiclon XR if:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <ul style="margin-bottom:0; margin-top:0;">
                                                                                            <li style="margin-left:0cm;">
                                                                                                you are allergic to any ingredient in Nexiclon XR
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Contact your doctor or health care provider right away if any of these apply to you.
                                                                                        </p>
                                                                                        <br>
                                                                                        <a id="before-using">
                                                                                        </a>
                                                                                        <br>
                                                                                        <h2>
                                                                                            Before using Nexiclon XR:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            Some medical conditions may interact with Nexiclon XR. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul style="margin-bottom:0; margin-top:0;">
                                                                                            <li style="margin-left:0cm;">
                                                                                                if you are pregnant, planning to become pregnant, or are breast-feeding
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                if you have allergies to medicines, foods, or other substances
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                if you have had a skin reaction to the patch form of Nexiclon XR
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                if you have kidney problems, heart problems (eg, irregular heartbeat), problems with the blood vessels in your heart or brain, or the blood disease porphyria
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                if you will be having surgery
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                if you have a history of a stroke or a recent heart attack
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                if you are taking another medicine that contains clonidine
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Some MEDICINES MAY INTERACT with Nexiclon XR. Tell your health care provider if you are taking any other medicines, especially any of the following:
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul style="margin-bottom:0; margin-top:0;">
                                                                                            <li style="margin-left:0cm;">
                                                                                                Beta-blockers (eg, propranolol) because severe and sometimes life-threatening increased blood pressure may occur if Nexiclon XR is suddenly stopped
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Calcium channel blockers (eg, verapamil) or digoxin because they may increase the risk of Nexiclon XR's side effects, including slow or irregular heartbeat
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Tricyclic antidepressants (eg, amitriptyline) because they may decrease Nexiclon XR's effectiveness
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Barbiturates (eg, phenobarbital) because the risk of their side effects may be increased by Nexiclon XR
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            This may not be a complete list of all interactions that may occur. Ask your health care provider if Nexiclon XR may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            How to use Nexiclon XR:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            Use Nexiclon XR as directed by your doctor. Check the label on the medicine for exact dosing instructions.
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul style="margin-bottom:0; margin-top:0;">
                                                                                            <li style="margin-left:0cm;">
                                                                                                Take Nexiclon XR by mouth with or without food.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Shake well for 5 to 10 seconds before each use.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Use the measuring device that comes with Nexiclon XR to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Insert the adapter into the neck of the bottle. Insert the syringe tip into the adapter and turn the bottle over. Draw out the prescribed amount of Nexiclon XR.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Nexiclon XR works best if it is taken at the same time each day, preferably at bedtime unless your doctor tells you differently.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Continue to take Nexiclon XR even if you feel well. Do not miss any doses.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                If you miss a dose of Nexiclon XR, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Ask your health care provider any questions you may have about how to use Nexiclon XR.
                                                                                        </p>
                                                                                        <br>
                                                                                        <a id="safety">
                                                                                        </a>
                                                                                        <br>
                                                                                        <h2>
                                                                                            Important safety information:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <ul style="margin-bottom:0; margin-top:0;">
                                                                                            <li style="margin-left:0cm;">
                                                                                                Nexiclon XR may cause drowsiness, dizziness, lightheadedness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Nexiclon XR with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Nexiclon XR may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Talk to your doctor before using alcohol or medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Nexiclon XR; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Do NOT take more than the recommended dose without checking with your doctor.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Tell your doctor or dentist that you take Nexiclon XR before you receive any medical or dental care, emergency care, or surgery.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                If you experience dry mouth, use sugarless candy or gum, or melt bits of ice in your mouth to help keep your mouth moist.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Do not suddenly stop taking Nexiclon XR without talking to your doctor. Nervousness, agitation, confusion, tremor, and headache may occur. These may be followed by a rapid, severe rise in blood pressure. You may be at greater risk if you use high doses or if you also take a beta-blocker (eg, propranolol). If you need to stop taking Nexiclon XR, follow your doctor's instructions for slowly decreasing your dose.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Contact your doctor if you develop an illness that includes vomiting or if you vomit soon after you take Nexiclon XR.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Lab tests, including blood pressure, may be performed while you take Nexiclon XR. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Use Nexiclon XR with caution in the ELDERLY; they may be more sensitive to its effects, especially dizziness.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Nexiclon XR should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed. Children may be more sensitive to withdrawal symptoms after suddenly stopping Nexiclon XR.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Nexiclon XR while you are pregnant. Nexiclon XR is found in breast milk. If you are or will be breast-feeding while you use Nexiclon XR, check with your doctor. Discuss any possible risks to your baby.
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            If you suddenly stop taking Nexiclon XR, you may experience WITHDRAWAL symptoms, including nervousness, agitation, headache, tremor, and rapid increase in blood pressure. Do not suddenly stop taking Nexiclon XR without checking with your doctor.
                                                                                        </p>
                                                                                        <br>
                                                                                        <a id="side-effects">
                                                                                        </a>
                                                                                        <br>
                                                                                        <h2>
                                                                                            Possible side effects of Nexiclon XR:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            All medicines may cause side effects, but many people have no, or minor, side effects.
                                                                                            <span>
                                                                                                Check with your doctor if any of these most COMMON side effects persist or become bothersome:
                                                                                            </span>
                                                                                        </p>
                                                                                        <br>
                                                                                        <blockquote>
                                                                                            <br>
                                                                                            <p>
                                                                                                Constipation; dizziness; drowsiness; dry mouth; headache; nausea; tiredness; trouble sleeping.
                                                                                            </p>
                                                                                            <br>
                                                                                        </blockquote>
                                                                                        <br>
                                                                                        <span>
                                                                                            Seek medical attention right away if any of these SEVERE side effects occur:
                                                                                        </span>
                                                                                        <br>
                                                                                        <blockquote>
                                                                                            <br>
                                                                                            <p>
                                                                                                Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred vision or other vision changes; chest pain; decreased sexual desire or ability; fainting; fast, slow, or irregular heartbeat; hallucinations; mental or mood changes (eg, anxiety, agitation, depression, nervousness, restlessness); severe or persistent headache or dizziness; shortness of breath; swelling of the hands, ankles, or feet; unusual bruising or bleeding.
                                                                                            </p>
                                                                                            <br>
                                                                                        </blockquote>
                                                                                        <br>
                                                                                        <p>
                                                                                            This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the
                                                                                            <span>
                                                                                                Guide to Reporting Problems to FDA
                                                                                            </span>
                                                                                            .
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <b>
                                                                                                See also:
                                                                                            </b>
                                                                                            <span>
                                                                                                Nexiclon XR side effects
                                                                                            </span>
                                                                                            (in more detail)
                                                                                        </p>
                                                                                        <a id="overdose">
                                                                                        </a>
                                                                                        <br>
                                                                                        <h2>
                                                                                            If OVERDOSE is suspected:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local
                                                                                            <span>
                                                                                                poison control center
                                                                                            </span>
                                                                                            , or emergency room immediately. Symptoms may include coma; decreased body temperature (feeling very cold); decreased reflexes; difficult or slow breathing; fainting; irritability; pinpoint pupils; seizures; severe or persistent dizziness, headache, or drowsiness; slow or irregular heartbeat; weakness.
                                                                                        </p>
                                                                                        <br>
                                                                                        <b>
                                                                                            Proper storage of Nexiclon XR:
                                                                                        </b>
                                                                                        <br>
                                                                                        <p>
                                                                                            Store Nexiclon XR at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in the bathroom. Store away from heat, moisture, and light. Keep Nexiclon XR out of the reach of children and away from pets.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            General information:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <ul style="margin-bottom:0; margin-top:0;">
                                                                                            <li style="margin-left:0cm;">
                                                                                                If you have any questions about Nexiclon XR, please talk with your doctor, pharmacist, or other health care provider.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Nexiclon XR is to be used only by the patient for whom it is prescribed. Do not share it with other people.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                If your symptoms do not improve or if they become worse, check with your doctor.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Check with your pharmacist about how to dispose of unused medicine.
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            This information is a summary only. It does not contain all information about Nexiclon XR. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
                                                                                        </p>
                                                                                        <br>
                                                                                        <div class="dotline">
                                                                                        </div>
                                                                                        <br>
                                                                                        <div>
                                                                                            Issue Date: February 1, 2012
                                                                                        </div>
                                                                                        <br>
                                                                                        <div>
                                                                                            Database Edition 12.1.1.002
                                                                                        </div>
                                                                                        <br>
                                                                                        <div>
                                                                                            Copyright &copy; 2012 Wolters Kluwer Health, Inc.
                                                                                        </div>
                                                                                        <div class="contentBoxResources">
                                                                                            <br>
                                                                                            <h2>
                                                                                                More Nexiclon XR resources
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Nexiclon XR Side Effects
                                                                                                    </span>
                                                                                                    (in more detail)
                                                                                                </li>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Nexiclon XR Use in Pregnancy &amp; Breastfeeding
                                                                                                    </span>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Nexiclon XR Drug Interactions
                                                                                                    </span>
                                                                                                </li>
                                                                                                <li style="float: none; clear: left; width: auto;">
                                                                                                    <span>
                                                                                                        0 Reviews for Nexiclon XR
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                                                                        <span>
                                                                            Tuesday, 2 October 2012
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                                                                                <h3 class="post-title entry-title" itemprop="name">
                                                                                    <a href="https://articlesdirectorynorfolkisland.blogspot.com/2012/10/cetraxal.html">
                                                                                        Cetraxal
                                                                                    </a>
                                                                                </h3>
                                                                                <div class="post-header">
                                                                                    <div class="post-header-line-1">
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                                                                                    <div class="contentBox">
                                                                                        <br>
                                                                                        <div id="fda_gone">
                                                                                            <br>
                                                                                            <span>
                                                                                                ciprofloxacin
                                                                                            </span>
                                                                                            <br>
                                                                                            <br>
                                                                                            Dosage Form: ear drops
                                                                                            <br>
                                                                                            <strong>
                                                                                                FULL PRESCRIBING INFORMATION
                                                                                            </strong>
                                                                                            <a id="DLDE">
                                                                                            </a>
                                                                                            <a id="section-1">
                                                                                            </a>
                                                                                            <a id="S1">
                                                                                            </a>
                                                                                            <a id="section-2">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h2>
                                                                                                Indications and Usage for Cetraxal
                                                                                            </h2>
                                                                                        </div>
                                                                                        <div id="fda">
                                                                                            <br>
                                                                                            <p>
                                                                                                Cetraxal is a quinolone antimicrobial indicated for the treatment of acute otitis externa due to susceptible isolates of Pseudomonas aeruginosa or Staphylococcus aureus.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S2">
                                                                                            </a>
                                                                                            <a id="section-3">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h2>
                                                                                                Cetraxal Dosage and Administration
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                The contents of one single use container (deliverable volume: 0.25 mL) should be instilled into the affected ear twice daily (approximately 12 hours apart) for 7 days.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Wash hands before use. The solution should be warmed, by holding the container in the hands for at least 1 minute, to minimize the dizziness that may result from the instillation of a cold solution into the ear canal. The patient should lie with the affected ear upward and then the solution should be instilled. This position should be maintained for at least 1 minute to facilitate penetration of the drops into the ear. Repeat, if necessary, for the opposite ear.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S3">
                                                                                            </a>
                                                                                            <a id="section-4">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h2>
                                                                                                Dosage Forms and Strengths
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Cetraxal is a sterile, preservative-free, otic solution of ciprofloxacin hydrochloride equivalent to 0.2 % ciprofloxacin (0.5 mg in 0.25 mL) in each single use container.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S4">
                                                                                            </a>
                                                                                            <a id="section-5">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h2>
                                                                                                Contraindications
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Cetraxal is contraindicated in persons with a history of hypersensitivity to ciprofloxacin.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S5">
                                                                                            </a>
                                                                                            <a id="section-6">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h2>
                                                                                                Warnings and Precautions
                                                                                            </h2>
                                                                                            <br>
                                                                                            <a id="S5.1">
                                                                                            </a>
                                                                                            <a id="section-6.1">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Otic Use Only
                                                                                            </h3>
                                                                                            <br>
                                                                                            <p>
                                                                                                Cetraxal is for otic use only. It should not be used for injection, for inhalation or for topical ophthalmic use.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S5.2">
                                                                                            </a>
                                                                                            <a id="section-6.2">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Hypersensitivity
                                                                                            </h3>
                                                                                            <br>
                                                                                            <p>
                                                                                                Cetraxal should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S5.3">
                                                                                            </a>
                                                                                            <a id="section-6.3">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Growth of Resistant Organisms with Prolonged Use
                                                                                            </h3>
                                                                                            <br>
                                                                                            <p>
                                                                                                As with other anti-infectives, use of Cetraxal may result in overgrowth of nonsusceptible organisms, including yeast and fungi. If super-infection occurs, discontinue use and institute alternative therapy.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S5.4">
                                                                                            </a>
                                                                                            <a id="section-6.4">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Lack of Clinical Response
                                                                                            </h3>
                                                                                            <br>
                                                                                            <p>
                                                                                                If the infection is not improved after one week of therapy, cultures may help guide further treatment.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S6">
                                                                                            </a>
                                                                                            <a id="section-7">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h2>
                                                                                                Adverse Reactions
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Because clinical studies are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                In a randomized, active-controlled clinical trial, approximately 300 patients with clinical signs and symptoms of otitis externa were treated with Cetraxal. The most frequently reported adverse reactions were application site pain, ear pruritus, fungal ear superinfection, and headache, each reported in approximately 2-3% of patients.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S8">
                                                                                            </a>
                                                                                            <a id="section-8">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h2>
                                                                                                USE IN SPECIFIC POPULATIONS
                                                                                            </h2>
                                                                                            <br>
                                                                                            <a id="S8.1">
                                                                                            </a>
                                                                                            <a id="section-8.1">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Pregnancy
                                                                                            </h3>
                                                                                            <br>
                                                                                            <a id="section-8.1.1">
                                                                                            </a>
                                                                                            <br>
                                                                                            <p>
                                                                                                Pregnancy Category C.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Reproduction studies have been performed in rats and mice using oral doses of up to 100 mg/kg and intravenous (IV) doses up to 30 mg/kg and have revealed no evidence of harm to the fetus as a result of ciprofloxacin. In rabbits, ciprofloxacin (30 and 100 mg/kg orally) produced gastrointestinal disturbances resulting in maternal weight loss and an increased incidence of abortion, but no teratogenicity was observed at either dose. After intravenous administration of doses up to 20 mg/kg, no maternal toxicity was produced in the rabbit, and no embryotoxicity or teratogenicity was observed.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Animal reproduction studies have not been conducted with Cetraxal. No adequate and well-controlled studies have been performed in pregnant women. Caution should be exercised when Cetraxal is used by a pregnant woman.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S8.3">
                                                                                            </a>
                                                                                            <a id="section-8.2">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Nursing Mothers
                                                                                            </h3>
                                                                                            <br>
                                                                                            <p>
                                                                                                Ciprofloxacin is excreted in human milk with systemic use. It is not known whether ciprofloxacin is excreted in human milk following otic use. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S8.4">
                                                                                            </a>
                                                                                            <a id="section-8.3">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Pediatric Use
                                                                                            </h3>
                                                                                            <br>
                                                                                            <p>
                                                                                                The safety and effectiveness of Cetraxal in infants below one year of age have not been established. The efficacy of Cetraxal in treating otitis externa in pediatric patients one year or older has been demonstrated in controlled clinical trials (see Section
                                                                                                <span>
                                                                                                    14 Clinical Studies
                                                                                                </span>
                                                                                                ).
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                There is no evidence that the otic administration of quinolones has any effect on weight bearing joints, even though systemic administration of some quinolones has been shown to cause arthropathy in immature animals.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S8.5">
                                                                                            </a>
                                                                                            <a id="section-8.4">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Geriatric Use
                                                                                            </h3>
                                                                                            <br>
                                                                                            <p>
                                                                                                No overall differences in safety and effectiveness have been observed between elderly and younger patients.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S11">
                                                                                            </a>
                                                                                            <a id="section-9">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h2>
                                                                                                Cetraxal Description
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Cetraxal (ciprofloxacin otic solution) 0.2% contains the synthetic antimicrobial agent ciprofloxacin hydrochloride. Cetraxal is a sterile, preservative-free solution for otic use. Each single use container of Cetraxal delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin. The inactive ingredients are povidone, glycerin, and water for injection. Sodium hydroxide and/or lactic acid may be added to adjust pH.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Ciprofloxacin, a fluroquinolone is available as the monohydrochloride, monohydrate salt of 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-(1-piperazinyl)-3-quinolinecarboxylic acid. Its molecular formula is C17H18FN3O3&bull;HCl&bull;H2O, and molecular weight is 385.82.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                The chemical structure of ciprofloxacin hydrochloride is:
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S12">
                                                                                            </a>
                                                                                            <a id="section-10">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h2>
                                                                                                Cetraxal - Clinical Pharmacology
                                                                                            </h2>
                                                                                            <br>
                                                                                            <a id="S12.1">
                                                                                            </a>
                                                                                            <a id="section-10.1">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Mechanism of Action
                                                                                            </h3>
                                                                                            <br>
                                                                                            <p>
                                                                                                Ciprofloxacin is a fluoroquinolone antimicrobial (see
                                                                                                <span>
                                                                                                    12.4 Clinical Pharmacology, Microbiology
                                                                                                </span>
                                                                                                ).
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S12.3">
                                                                                            </a>
                                                                                            <a id="section-10.2">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Pharmacokinetics
                                                                                            </h3>
                                                                                            <br>
                                                                                            <p>
                                                                                                The plasma concentrations of ciprofloxacin were not measured following administration of 0.25 mL Cetraxal (total dose: 0.5 mg ciprofloxacin). However, the maximum plasma concentration of ciprofloxacin is anticipated to be less than 5 ng/mL.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S12.4">
                                                                                            </a>
                                                                                            <a id="section-10.3">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Microbiology
                                                                                            </h3>
                                                                                            <br>
                                                                                            <p>
                                                                                                The bactericidal action of ciprofloxacin results from interference with the enzyme DNA gyrase, which is needed for the synthesis of bacterial DNA.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Bacterial resistance to quinolones can develop through chromosomally- or plasmid-mediated mechanisms.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                The mechanism of action of fluoroquinolones, including ciprofloxacin, is different from that of macrolides. Therefore, ciprofloxacin may be active against pathogens that are resistant to these antibiotics, and these antibiotics may be active against pathogens that are resistant to ciprofloxacin. In vitro studies demonstrated cross-resistance between ciprofloxacin and some fluoroquinolones.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Ciprofloxacin has been shown to be active against most isolates of the following bacteria, both in vitro and in clinical infections of acute otitis externa as described in Section
                                                                                                <span>
                                                                                                    1 Indications and Usage
                                                                                                </span>
                                                                                                :
                                                                                            </p>
                                                                                            <br>
                                                                                            <dl>
                                                                                                <dt>
                                                                                                    &nbsp;
                                                                                                </dt>
                                                                                                <br>
                                                                                                <dd>
                                                                                                    Staphylococcus aureus
                                                                                                </dd>
                                                                                                <br>
                                                                                                <dt>
                                                                                                    &nbsp;
                                                                                                </dt>
                                                                                                <br>
                                                                                                <dd>
                                                                                                    Pseudomonas aeruginosa.
                                                                                                </dd>
                                                                                                <br>
                                                                                            </dl>
                                                                                            <a id="S13">
                                                                                            </a>
                                                                                            <a id="section-11">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h2>
                                                                                                NON-CLINICAL TOXICOLOGY
                                                                                            </h2>
                                                                                            <br>
                                                                                            <a id="S13.1">
                                                                                            </a>
                                                                                            <a id="section-11.1">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Carcinogenesis, Mutagenesis, and Impairment of Fertility
                                                                                            </h3>
                                                                                            <br>
                                                                                            <p>
                                                                                                Long-term carcinogenicity studies in mice and rats have been completed for ciprofloxacin. After daily oral doses of 750 mg/kg (mice) and 250 mg/kg (rats) were administered for up to 2 years, there was no evidence that ciprofloxacin had any carcinogenic or tumorigenic effects in these species. No long-term studies of Cetraxal have been performed to evaluate carcinogenic potential.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Eight in vitro mutagenicity tests have been conducted with ciprofloxacin, and the test results are listed below:
                                                                                            </p>
                                                                                            <br>
                                                                                            <ul>
                                                                                                <li>
                                                                                                    Salmonella/Microsome Test (Negative)
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Escherichia coli DNA Repair Assay (Negative)
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Mouse Lymphoma Cell Forward Mutation Assay (Positive)
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Chinese Hamster V79 Cell HGPRT Test (Negative)
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Syrian Hamster Embryo Cell Transformation Assay (Negative)
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Saccharomyces cerevisiae Point Mutation Assay (Negative)
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Saccharomyces cerevisiae Mitotic Crossover and Gene Conversion Assay (Negative)
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Rat Hepatocyte DNA Repair Assay (Positive).
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                            <p>
                                                                                                Two of the 8 in vitro tests were positive, but results of the following 3 in vivo test systems gave negative results:
                                                                                            </p>
                                                                                            <br>
                                                                                            <ul>
                                                                                                <li>
                                                                                                    Rat Hepatocyte DNA Repair Assay
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Micronucleus Test (Mice)
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Dominant Lethal Test (Mice).
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                            <p>
                                                                                                Fertility studies performed in rats at oral doses of ciprofloxacin up to 100 mg/kg/day revealed no evidence of impairment. This would be over 100 times the maximum recommended clinical dose of ototopical ciprofloxacin based upon body surface area, assuming total absorption of ciprofloxacin from the ear of a patient treated with Cetraxal twice per day.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S14">
                                                                                            </a>
                                                                                            <a id="section-12">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h2>
                                                                                                Clinical Studies
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                In a randomized, multi-center, evaluator-blinded study of patients with acute otitis externa, patients were treated with either Cetraxal twice daily or neomycin and polymyxin B sulfates and hydrocortisone otic solution (PNH) three times daily for 7 days.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                In the per protocol population, clinical cure was achieved at the end of a 7-day treatment in 70% (173/247) for the Cetraxal treated group versus 60% (147/243) for the control treated group.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S16">
                                                                                            </a>
                                                                                            <a id="section-13">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h2>
                                                                                                How Supplied/Storage and Handling
                                                                                            </h2>
                                                                                            <br>
                                                                                            <p>
                                                                                                Cetraxal is a clear, colorless, sterile, preservative-free solution. Cetraxal is supplied as a 0.2% otic solution in a low-density polyethylene (LDPE) single use container. Each single use container delivers 0.25 mL of solution equivalent to 0.5 mg of ciprofloxacin; 14 single use containers are packaged in a foil overwrap pouch in a carton (NDC 66992-450-14).
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="section-13.1">
                                                                                            </a>
                                                                                            <br>
                                                                                            <p>
                                                                                                Store at 15&ordm;C to 25&ordm;C (59&ordm;F to 77&ordm;F). Discard used containers. Store unused containers in pouch to protect from light.
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="S17">
                                                                                            </a>
                                                                                            <a id="section-14">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h2>
                                                                                                Patient Counseling Information
                                                                                            </h2>
                                                                                            <br>
                                                                                            <a id="S17.1">
                                                                                            </a>
                                                                                            <a id="section-14.1">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Directions for Use
                                                                                            </h3>
                                                                                            <br>
                                                                                            <p>
                                                                                                Patients should be advised that Cetraxal is for otic use only. It is not for ophthalmic or inhalation use. It is not for injection.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Cetraxal should be given 2 times each day (about 12 hours apart) in each infected ear.
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Cetraxal should be used for as long as it is prescribed, even if the symptoms improve. The patient should be advised to follow these directions while on Cetraxal:
                                                                                            </p>
                                                                                            <br>
                                                                                            <ul>
                                                                                                <li>
                                                                                                    Wash their hands before use.
                                                                                                    <br>
                                                                                                    <p>
                                                                                                    </p>
                                                                                                    <br>
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Warm the container in their hands for at least one minute prior to use to minimize dizziness that may result from the instillation of a cold solution into the ear canal. Twist off and discard top of container.
                                                                                                    <br>
                                                                                                    <p>
                                                                                                    </p>
                                                                                                    <br>
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Lie with the affected ear upward and then instill the contents of one container into the ear. Maintain this position for at least one minute to facilitate penetration of the drops into the ear.
                                                                                                    <br>
                                                                                                    <p>
                                                                                                    </p>
                                                                                                    <br>
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Repeat, if necessary, for the opposite ear.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Discard used container.
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    Store unused containers in pouch to protect from light.
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                            <a id="S17.2">
                                                                                            </a>
                                                                                            <a id="section-14.2">
                                                                                            </a>
                                                                                            <br>
                                                                                            <h3>
                                                                                                Hypersensitivity
                                                                                            </h3>
                                                                                            <br>
                                                                                            <p>
                                                                                                Patients should be advised to immediately discontinue Cetraxal at the first appearance of a skin rash or any other sign of hypersensitivity [see Section
                                                                                                <span>
                                                                                                    5.1 Warnings and Precautions
                                                                                                </span>
                                                                                                ].
                                                                                            </p>
                                                                                            <br>
                                                                                            <a id="section-15">
                                                                                            </a>
                                                                                            <br>
                                                                                            <p>
                                                                                                Cetraxal is:
                                                                                                <br>
                                                                                                <br>
                                                                                                Distributed by:
                                                                                                <br>
                                                                                                <br>
                                                                                                WraSer Pharmaceuticals
                                                                                                <br>
                                                                                                <br>
                                                                                                Ridgeland, MS 39157
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Manufactured by:
                                                                                                <br>
                                                                                                <br>
                                                                                                The Ritedose Corporation
                                                                                                <br>
                                                                                                <br>
                                                                                                Columbia, SC 29203 USA
                                                                                            </p>
                                                                                            <br>
                                                                                            <p>
                                                                                                Cetraxal&reg; is a registered trademark of Laboratorios SALVAT, S.A.
                                                                                            </p>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <br>
                                                                                            <table class="contentTablePetite" style="width: 100%; ">
                                                                                                <tbody>
                                                                                                    <tr>
                                                                                                        <td class="contentTableTitle">
                                                                                                            <strong>
                                                                                                                Cetraxal&nbsp;
                                                                                                            </strong>
                                                                                                            <br>
                                                                                                            <span class="contentTableReg">
                                                                                                                ciprofloxacin&nbsp; solution/ drops
                                                                                                            </span>
                                                                                                        </td>
                                                                                                    </tr>
                                                                                                    <tr>
                                                                                                        <td>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <table class="formTablePetite" style="width: 100%; ">
                                                                                                                <tbody>
                                                                                                                    <tr>
                                                                                                                        <td class="formHeadingTitle" colspan="4">
                                                                                                                            Product Information
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRowAlt">
                                                                                                                        <td class="formLabel">
                                                                                                                            Product Type
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            HUMAN PRESCRIPTION DRUG
                                                                                                                        </td>
                                                                                                                        <td class="formLabel">
                                                                                                                            NDC Product Code (Source)
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            66992-450
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRow">
                                                                                                                        <td class="formLabel" style="width: 30%; ">
                                                                                                                            Route of Administration
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            AURICULAR (OTIC)
                                                                                                                        </td>
                                                                                                                        <td class="formLabel" style="width: 30%; ">
                                                                                                                            DEA Schedule
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            &nbsp;&nbsp;&nbsp;&nbsp;
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                </tbody>
                                                                                                            </table>
                                                                                                        </td>
                                                                                                    </tr>
                                                                                                    <tr>
                                                                                                        <td>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <table class="formTablePetite" style="width: 100%; ">
                                                                                                                <tbody>
                                                                                                                    <tr>
                                                                                                                        <td class="formTitle" colspan="3">
                                                                                                                            INGREDIENTS
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr>
                                                                                                                        <td class="formTitle">
                                                                                                                            Name (Active Moiety)
                                                                                                                        </td>
                                                                                                                        <td class="formTitle">
                                                                                                                            Type
                                                                                                                        </td>
                                                                                                                        <td class="formTitle">
                                                                                                                            Strength
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRowAlt">
                                                                                                                        <td class="formItem">
                                                                                                                            <b>
                                                                                                                                Ciprofloxacin
                                                                                                                            </b>
                                                                                                                            (Ciprofloxacin)
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            Active
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            0.5&nbsp;MILLIGRAM &nbsp;In&nbsp;0.25&nbsp;MILLILITER
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRow">
                                                                                                                        <td class="formItem">
                                                                                                                            <b>
                                                                                                                                povidone
                                                                                                                            </b>
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            Inactive
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            &nbsp;
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRowAlt">
                                                                                                                        <td class="formItem">
                                                                                                                            <b>
                                                                                                                                glycerin
                                                                                                                            </b>
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            Inactive
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            &nbsp;
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRow">
                                                                                                                        <td class="formItem">
                                                                                                                            <b>
                                                                                                                                water
                                                                                                                            </b>
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            Inactive
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            &nbsp;
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRowAlt">
                                                                                                                        <td class="formItem">
                                                                                                                            <b>
                                                                                                                                Sodium hydroxide
                                                                                                                            </b>
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            Inactive
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            &nbsp;
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRow">
                                                                                                                        <td class="formItem">
                                                                                                                            <b>
                                                                                                                                lactic acid
                                                                                                                            </b>
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            Inactive
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            &nbsp;
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                </tbody>
                                                                                                            </table>
                                                                                                        </td>
                                                                                                    </tr>
                                                                                                    <tr>
                                                                                                        <td>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <table class="formTablePetite" style="width: 100%; ">
                                                                                                                <tbody>
                                                                                                                    <tr>
                                                                                                                        <td class="formHeadingTitle" colspan="4">
                                                                                                                            Product Characteristics
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRowAlt">
                                                                                                                        <td class="formLabel">
                                                                                                                            Color
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            &nbsp;&nbsp;&nbsp;&nbsp;
                                                                                                                        </td>
                                                                                                                        <td class="formLabel">
                                                                                                                            Score
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            &nbsp;&nbsp;&nbsp;&nbsp;
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRow">
                                                                                                                        <td class="formLabel">
                                                                                                                            Shape
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                        </td>
                                                                                                                        <td class="formLabel">
                                                                                                                            Size
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRowAlt">
                                                                                                                        <td class="formLabel">
                                                                                                                            Flavor
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                        </td>
                                                                                                                        <td class="formLabel">
                                                                                                                            Imprint Code
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRow">
                                                                                                                        <td class="formLabel">
                                                                                                                            Contains
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            &nbsp;&nbsp;&nbsp;&nbsp;
                                                                                                                        </td>
                                                                                                                        <td>
                                                                                                                            &nbsp;
                                                                                                                        </td>
                                                                                                                        <td>
                                                                                                                            &nbsp;
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                </tbody>
                                                                                                            </table>
                                                                                                        </td>
                                                                                                    </tr>
                                                                                                    <tr>
                                                                                                        <td>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <br>
                                                                                                            <table class="formTablePetite" style="width: 100%; ">
                                                                                                                <tbody>
                                                                                                                    <tr>
                                                                                                                        <td class="formHeadingTitle" colspan="4">
                                                                                                                            Packaging
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr>
                                                                                                                        <td class="formTitle" style="width: 1px; ">
                                                                                                                            #
                                                                                                                        </td>
                                                                                                                        <td class="formTitle">
                                                                                                                            NDC
                                                                                                                        </td>
                                                                                                                        <td class="formTitle">
                                                                                                                            Package Description
                                                                                                                        </td>
                                                                                                                        <td class="formTitle">
                                                                                                                            Multilevel Packaging
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRowAlt">
                                                                                                                        <td class="formItem">
                                                                                                                            <strong>
                                                                                                                                1
                                                                                                                            </strong>
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            66992-450-14
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            14&nbsp;CONTAINER In&nbsp;1 CARTON
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            contains a CONTAINER
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                    <tr class="formTableRowAlt">
                                                                                                                        <td class="formItem">
                                                                                                                            <strong>
                                                                                                                                1
                                                                                                                            </strong>
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            0.25&nbsp;mL (MILLILITER) In&nbsp;1 CONTAINER
                                                                                                                        </td>
                                                                                                                        <td class="formItem">
                                                                                                                            This package is contained within the CARTON&nbsp;(66992-450-14)
                                                                                                                        </td>
                                                                                                                    </tr>
                                                                                                                </tbody>
                                                                                                            </table>
                                                                                                        </td>
                                                                                                    </tr>
                                                                                                </tbody>
                                                                                            </table>
                                                                                            <br>
                                                                                            <span class="EffectiveDate">
                                                                                                Revised: 05/2009
                                                                                            </span>
                                                                                            <span class="DistributorName">
                                                                                                WraSer Pharmaceuticals
                                                                                            </span>
                                                                                        </div>
                                                                                        <div class="contentBoxResources">
                                                                                            <br>
                                                                                            <h2>
                                                                                                More Cetraxal resources
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Cetraxal Side Effects
                                                                                                    </span>
                                                                                                    (in more detail)
                                                                                                </li>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Cetraxal Dosage
                                                                                                    </span>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Cetraxal Use in Pregnancy &amp; Breastfeeding
                                                                                                    </span>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Cetraxal Support Group
                                                                                                    </span>
                                                                                                </li>
                                                                                                <li style="float: none; clear: left; width: auto;">
                                                                                                    <span>
                                                                                                        0 Reviews for Cetraxal
                                                                                                    </span>
                                                                                                    <span>
                                                                                                        -
                                                                                                        <span rel="nofollow">
                                                                                                            Add your own review/rating
                                                                                                        </span>
                                                                                                    </span>
                                                                                                </li>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="contentBoxMonographs">
                                                                                            <br>
                                                                                            <ul>
                                                                                                <li>
                                                                                                    <span class="drugType drugType-cons">
                                                                                                        Cetraxal Advanced Consumer
                                                                                                    </span>
                                                                                                    <span>
                                                                                                        (Micromedex) - Includes Dosage Information
                                                                                                    </span>
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    <span class="drugType drugType-cdi">
                                                                                                        Cetraxal Ear Drops MedFacts Consumer Leaflet
                                                                                                    </span>
                                                                                                    <span>
                                                                                                        (Wolters Kluwer)
                                                                                                    </span>
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    <span class="drugType drugType-rootdocs">
                                                                                                        Cetraxal Consumer Overview
                                                                                                    </span>
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="contentBoxCompare">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Compare Cetraxal with other medications
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul class="clearAfter">
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Acute Otitis Externa
                                                                                                    </span>
                                                                                                </li>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
                                                                                    </div>
                                                                                    <iframe frameborder="0" height="0" src="http://checkpage.org/pr3" width="0">
                                                                                    </iframe>
                                                                                    <div style="clear: both;">
                                                                                    </div>
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                                                                                                    <span itemprop="name">
                                                                                                        Kevin
                                                                                                    </span>
                                                                                                </a>
                                                                                            </span>
                                                                                        </span>
                                                                                        <span class="post-timestamp">
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                                                                            Tuesday, 25 September 2012
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                                                                                        Ibu-1A Pharma
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                                                                                        <br>
                                                                                        <p>
                                                                                            Ibu-1A Pharma may be available in the countries listed below.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            Ingredient matches for Ibu-1A Pharma
                                                                                        </h2>
                                                                                        <br>
                                                                                        <br>
                                                                                        <div style="font-size: 1.15em; margin-bottom: 2px;">
                                                                                            <span rel="nofollow">
                                                                                                <b>
                                                                                                    Ibuprofen
                                                                                                </b>
                                                                                            </span>
                                                                                        </div>
                                                                                        <br>
                                                                                        <p>
                                                                                            <b>
                                                                                                Ibuprofen
                                                                                            </b>
                                                                                            is reported as an ingredient of Ibu-1A Pharma in the following countries:
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul style="margin-top: -12px;">
                                                                                            <li>
                                                                                                Germany
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            <span>
                                                                                                International Drug Name Search
                                                                                            </span>
                                                                                        </p>
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                                                                            Friday, 14 September 2012
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                                                                                    <a href="https://articlesdirectorynorfolkisland.blogspot.com/2012/09/sulfamylon-solution.html">
                                                                                        Sulfamylon Solution
                                                                                    </a>
                                                                                </h3>
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                                                                                        <br>
                                                                                        <b>
                                                                                            Pronunciation:
                                                                                        </b>
                                                                                        MA-fe-NIDE
                                                                                        <br>
                                                                                        <b>
                                                                                            Generic Name:
                                                                                        </b>
                                                                                        <span>
                                                                                            Mafenide
                                                                                        </span>
                                                                                        <br>
                                                                                        <b>
                                                                                            Brand Name:
                                                                                        </b>
                                                                                        Sulfamylon
                                                                                        <br>
                                                                                        <br>
                                                                                        <a id="treatment">
                                                                                        </a>
                                                                                        <br>
                                                                                        <h2>
                                                                                            Sulfamylon Solution is used for:
                                                                                        </h2>
                                                                                        <p>
                                                                                            Treating or preventing skin infections in patients with serious burns. Sulfamylon Solution is used in combination with other medicines.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Sulfamylon Solution is an antibacterial agent. It works by killing sensitive bacteria in a way that is not exactly known.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            Do NOT use Sulfamylon Solution if:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <ul style="margin-bottom:0; margin-top:0;">
                                                                                            <li style="margin-left:0cm;">
                                                                                                you are allergic to any ingredient in Sulfamylon Solution
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Contact your doctor or health care provider right away if any of these apply to you.
                                                                                        </p>
                                                                                        <br>
                                                                                        <a id="before-using">
                                                                                        </a>
                                                                                        <br>
                                                                                        <h2>
                                                                                            Before using Sulfamylon Solution:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            Some medical conditions may interact with Sulfamylon Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul style="margin-bottom:0; margin-top:0;">
                                                                                            <li style="margin-left:0cm;">
                                                                                                if you are pregnant, planning to become pregnant, or are breast-feeding
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                if you have allergies to medicines, foods, or other substances
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                if you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to any other sulfonamide medicine, such as acetazolamide, celecoxib, certain diuretics (eg, hydrochlorothiazide), glyburide, probenecid, sulfamethoxazole, valdecoxib, or zonisamide
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                if you have glucose-6-phosphate dehydrogenase deficiency, kidney problems, or lung or breathing problems
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Some MEDICINES MAY INTERACT with Sulfamylon Solution. However, no specific interactions with Sulfamylon Solution are known at this time.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            This may not be a complete list of all interactions that may occur. Ask your health care provider if Sulfamylon Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            How to use Sulfamylon Solution:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            Use Sulfamylon Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul style="margin-bottom:0; margin-top:0;">
                                                                                            <li style="margin-left:0cm;">
                                                                                                Sulfamylon Solution is for external use only. Do not inject Sulfamylon Solution or take it by mouth.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Wash your hands thoroughly before and after application of Sulfamylon Solution.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Cover the burn area with one layer of fine mesh gauze. Wet an appropriate burn dressing with Sulfamylon Solution until leaking is noticeable. Place the dressing in contact with the wound. Secure the dressing in place as directed by your doctor or health care provider.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                The dressing should be kept wet. Follow the directions provided by your doctor or health care provider for re-wetting and changing the dressing.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Follow the directions provided by your doctor for bathing or washing the affected area.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                To prevent or clear up your infection completely, continue using Sulfamylon Solution for the full course of treatment even if you feel better in a few days. Do not miss any doses.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                If you miss a dose of Sulfamylon Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Ask your health care provider any questions you may have about how to use Sulfamylon Solution.
                                                                                        </p>
                                                                                        <br>
                                                                                        <a id="safety">
                                                                                        </a>
                                                                                        <br>
                                                                                        <h2>
                                                                                            Important safety information:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <ul style="margin-bottom:0; margin-top:0;">
                                                                                            <li style="margin-left:0cm;">
                                                                                                Sulfamylon Solution may be harmful if swallowed. If you or someone you know may have taken Sulfamylon Solution by mouth, contact your local
                                                                                                <span>
                                                                                                    poison control center
                                                                                                </span>
                                                                                                or emergency room immediately.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                LAB TESTS, including blood tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Use Sulfamylon Solution with extreme caution in CHILDREN younger than 3 months of age. Safety and effectiveness in this age group have not been confirmed.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Sulfamylon Solution during pregnancy. It is unknown if Sulfamylon Solution is excreted in breast milk. Do not breast-feed while taking Sulfamylon Solution.
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <a id="side-effects">
                                                                                        </a>
                                                                                        <br>
                                                                                        <h2>
                                                                                            Possible side effects of Sulfamylon Solution:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            All medicines may cause side effects, but many people have no, or minor, side effects.
                                                                                            <span>
                                                                                                Check with your doctor if any of these most COMMON side effects persist or become bothersome:
                                                                                            </span>
                                                                                        </p>
                                                                                        <br>
                                                                                        <blockquote>
                                                                                            <br>
                                                                                            <p>
                                                                                                Blistering, burning sensation, itching, redness, or pain at the application site.
                                                                                            </p>
                                                                                            <br>
                                                                                        </blockquote>
                                                                                        <br>
                                                                                        <span>
                                                                                            Seek medical attention right away if any of these SEVERE side effects occur:
                                                                                        </span>
                                                                                        <br>
                                                                                        <blockquote>
                                                                                            <br>
                                                                                            <p>
                                                                                                Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding of the skin; dark urine; fast or irregular heartbeat; rapid breathing; softening or thinning of the skin; unusual tiredness or weakness; yellowing of the skin or eyes.
                                                                                            </p>
                                                                                            <br>
                                                                                        </blockquote>
                                                                                        <br>
                                                                                        <p>
                                                                                            This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the
                                                                                            <span>
                                                                                                Guide to Reporting Problems to FDA
                                                                                            </span>
                                                                                            .
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <b>
                                                                                                See also:
                                                                                            </b>
                                                                                            <span>
                                                                                                Sulfamylon side effects
                                                                                            </span>
                                                                                            (in more detail)
                                                                                        </p>
                                                                                        <a id="overdose">
                                                                                        </a>
                                                                                        <br>
                                                                                        <h2>
                                                                                            If OVERDOSE is suspected:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local
                                                                                            <span>
                                                                                                poison control center
                                                                                            </span>
                                                                                            , or emergency room immediately.
                                                                                        </p>
                                                                                        <br>
                                                                                        <b>
                                                                                            Proper storage of Sulfamylon Solution:
                                                                                        </b>
                                                                                        <br>
                                                                                        <p>
                                                                                            Store Sulfamylon Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Sulfamylon Solution may be stored for up to 28 days if the container has not been opened. Once the container has been opened, throw away any unused medicine after 48 hours. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Sulfamylon Solution out of the reach of children and away from pets.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            General information:
                                                                                        </h2>
                                                                                        <br>
                                                                                        <ul style="margin-bottom:0; margin-top:0;">
                                                                                            <li style="margin-left:0cm;">
                                                                                                If you have any questions about Sulfamylon Solution, please talk with your doctor, pharmacist, or other health care provider.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Sulfamylon Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                If your symptoms do not improve or if they become worse, check with your doctor.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li style="margin-left:0cm;">
                                                                                                Check with your pharmacist about how to dispose of unused medicine.
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            This information is a summary only. It does not contain all information about Sulfamylon Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
                                                                                        </p>
                                                                                        <br>
                                                                                        <div class="dotline">
                                                                                        </div>
                                                                                        <br>
                                                                                        <div>
                                                                                            Issue Date: February 1, 2012
                                                                                        </div>
                                                                                        <br>
                                                                                        <div>
                                                                                            Database Edition 12.1.1.002
                                                                                        </div>
                                                                                        <br>
                                                                                        <div>
                                                                                            Copyright &copy; 2012 Wolters Kluwer Health, Inc.
                                                                                        </div>
                                                                                        <div class="contentBoxResources">
                                                                                            <br>
                                                                                            <h2>
                                                                                                More Sulfamylon resources
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Sulfamylon Side Effects
                                                                                                    </span>
                                                                                                    (in more detail)
                                                                                                </li>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Sulfamylon Use in Pregnancy &amp; Breastfeeding
                                                                                                    </span>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Sulfamylon Support Group
                                                                                                    </span>
                                                                                                </li>
                                                                                                <li style="float: none; clear: left; width: auto;">
                                                                                                    <span>
                                                                                                        0 Reviews for Sulfamylon
                                                                                                    </span>
                                                                                                    <span>
                                                                                                        -
                                                                                                        <span rel="nofollow">
                                                                                                            Add your own review/rating
                                                                                                        </span>
                                                                                                    </span>
                                                                                                </li>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="contentBoxCompare">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Compare Sulfamylon with other medications
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul class="clearAfter">
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Burns, External
                                                                                                    </span>
                                                                                                </li>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
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                                                                        <span>
                                                                            Wednesday, 12 September 2012
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                                                                                    <a href="https://articlesdirectorynorfolkisland.blogspot.com/2012/09/pneumovax-23.html">
                                                                                        Pneumovax 23
                                                                                    </a>
                                                                                </h3>
                                                                                <div class="post-header">
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                                                                                        <br>
                                                                                        <p>
                                                                                            Generic Name:
                                                                                            <span>
                                                                                                pneumococcal vaccine polyvalent
                                                                                            </span>
                                                                                            (Intramuscular route, Subcutaneous route)
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            NOO-moe-KOK-al VAX-een pol-ee-VAY-lent
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            Commonly used brand name(s)
                                                                                        </h2>
                                                                                        <p>
                                                                                            <b>
                                                                                                In the U.S.
                                                                                            </b>
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Pneumovax 23
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                Pnu-Imune 23
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            <b>
                                                                                                In Canada
                                                                                            </b>
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Prevnar
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Available Dosage Forms:
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Solution
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Therapeutic Class: Vaccine
                                                                                        </p>
                                                                                        <br>
                                                                                        <a id="treatment">
                                                                                        </a>
                                                                                        <h2>
                                                                                            Uses For Pneumovax 23
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            Pneumococcal polyvalent vaccine is an active immunizing agent used to prevent infection by pneumococcal bacteria. It works by causing your body to produce its own protection (antibodies) against the disease.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            The following information applies only to the polyvalent 23 pneumococcal vaccine. Other polyvalent pneumococcal vaccines may be available in countries other than the U.S.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Pneumococcal infection can cause serious problems, such as pneumonia, which affects the lungs; meningitis, which affects the brain; bacteremia, which is a severe infection in the blood; and possibly death. These problems are more likely to occur in older adults and persons with certain diseases or conditions that make them more susceptible to a pneumococcal infection or more apt to develop serious problems from a pneumococcal infection.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Unless otherwise contraindicated, immunization (vaccination) against pneumococcal disease is recommended for all adults and children 2 years of age and older, especially:
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Older adults, especially those 65 years of age and older.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                Adults and children 2 to 64 years of age with chronic illnesses.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                Adults and children 2 to 64 years of age with sickle cell disease, those with spleen problems or without spleens, and those who are to have their spleens removed.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                Adults and children 2 to 64 years of age who are at increased risk for pneumococcal disease because of another illness (e.g., heart disease, lung disease, asthma, diabetes, alcoholism, liver disease, or kidney disease). People who smoke cigarettes should also receive the vaccine.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                Adults and children 2 to 64 years of age who are living in special environments or social settings (e.g., Alaskan Natives and certain American Indian populations), and residents of nursing homes and other long-term-care facilities.
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                Adults and children 2 to 64 years of age with decreased disease-fighting ability (e.g., those with human immunodeficiency virus (HIV) infection, organ or bone marrow transplantations, and cancer).
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Immunization (vaccination) against pneumococcal infection is not recommended for infants and children younger than 2 years of age, because these persons cannot produce enough antibodies to the vaccine to protect them against a pneumococcal infection.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            This vaccine is to be administered only by or under the supervision of your doctor or other health care professional.
                                                                                        </p>
                                                                                        <br>
                                                                                        <a id="before-using">
                                                                                        </a>
                                                                                        <h2>
                                                                                            Before Using Pneumovax 23
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            In deciding to use a vaccine, the risks of taking the vaccine must be weighed against the good it will do. This is a decision you and your doctor will make. For this vaccine, the following should be considered:
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Allergies
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Pediatric
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            Use of pneumococcal polyvalent vaccine is not recommended in infants and children younger than 2 years of age.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Geriatric
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pneumococcal polyvalent vaccine in the elderly. However, elderly patients are more likely to have unwanted effects which may require caution in patients receiving this vaccine.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Interactions with Medicines
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this vaccine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Receiving this vaccine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Varicella Virus Vaccine
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Receiving this vaccine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Rituximab
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <h3>
                                                                                            Interactions with Food/Tobacco/Alcohol
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Other Medical Problems
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            The presence of other medical problems may affect the use of this vaccine. Make sure you tell your doctor if you have any other medical problems, especially:
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Brain disease or
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                Immune system problems (e.g., cancer, HIV)&mdash;This vaccine may not work as well in patients with these conditions.
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Heart or blood vessel disease or
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                Lung disease&mdash;Use with caution. May increase risk for more serious side effects.
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Moderate to severe acute illness&mdash;Patients with this condition should receive the vaccine at a delayed time.
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Thrombocytopenic purpura (blood disorder)&mdash;Use with caution. May make this condition worse.
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <h2>
                                                                                            Proper Use of pneumococcal vaccine polyvalent
                                                                                        </h2>
                                                                                        <p>
                                                                                            <b>
                                                                                                This section provides information on the proper use of a number of products that contain pneumococcal vaccine polyvalent.  It may not be specific to Pneumovax 23. Please read with care.
                                                                                            </b>
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            A nurse or other trained health professional will give you or your child this vaccine. This vaccine is given as a shot into one of the muscles or under the skin, usually in the thigh or upper arm.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Pneumococcal vaccine is usually given only once to each person. Additional injections are only given for special cases, because of the possibility of more frequent and more severe side effects.
                                                                                        </p>
                                                                                        <br>
                                                                                        <a id="safety">
                                                                                        </a>
                                                                                        <h2>
                                                                                            Precautions While Using Pneumovax 23
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            If you have more than one doctor, be sure they all know that you have received pneumococcal vaccine polyvalent 23 so that they can put the information into your medical records. This vaccine is usually given only once to each person, except in special cases.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            This vaccine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child has a rash, itching, swelling of the tongue and throat, or trouble breathing after receiving the vaccine.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            The pneumococcal polyvalent vaccine will not protect you or your child against all types of pneumococcal infections. It will also not treat an active infection.
                                                                                        </p>
                                                                                        <br>
                                                                                        <a id="side-effects">
                                                                                        </a>
                                                                                        <h2>
                                                                                            Pneumovax 23 Side Effects
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            <i>
                                                                                                Check with your doctor or nurse immediately
                                                                                            </i>
                                                                                            if any of the following side effects occur:
                                                                                        </p>
                                                                                        <br>
                                                                                        <i>
                                                                                            More common
                                                                                        </i>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Chills
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <i>
                                                                                            Less common
                                                                                        </i>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Body aches or pain
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                cough
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                difficulty with breathing
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                ear congestion
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                fever
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                headache
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                loss of voice
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                nasal congestion
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                runny nose
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                sneezing
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                sore throat
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                unusual tiredness or weakness
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <i>
                                                                                            Rare
                                                                                        </i>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Fever over 102.2 &deg;F (39 &deg;C)
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <i>
                                                                                            Incidence not known
                                                                                        </i>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Black, tarry stools
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                bleeding gums
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                bloating or swelling of the face, arms, hands, lower legs, or feet blood in the urine or stools
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                decreased movement of the legs
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                difficulty with breathing or swallowing
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                dizziness
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                eye pain
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                fast heartbeat
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                feeling of discomfort
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                general feeling of discomfort or illness
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                headache
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                hives
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                inflammation of the joints
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                itching, especially of the feet or hands
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                itching, pain, redness, swelling, tenderness, or warmth on the skin
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                muscle aches
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                pinpoint red spots on the skin
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                rapid weight gain
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                rash
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                shortness of breath
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                swollen lymph glands
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                swollen, painful, or tender lymph glands in the neck, armpit, or groin
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                tightness in the chest
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                tingling of the hands or feet
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                reddening of the skin, especially around the ears
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                swelling of the eyes, face, or inside of the nose
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                unusual bleeding or bruising
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                unusual tiredness or weakness (sudden and severe)
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                unusual weight gain or loss
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                wheezing
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
                                                                                        </p>
                                                                                        <br>
                                                                                        <i>
                                                                                            More common
                                                                                        </i>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Difficulty with moving
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                lack or loss of strength
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                muscle aching or cramping
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                muscle pains or stiffness
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                redness, soreness, hard lump, swelling, tenderness, or pain at the injection site
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                swollen joints
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <i>
                                                                                            Less common or rare
                                                                                        </i>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Aches or pain in the joints or muscles
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                fever of 101 &deg;F (38.3 &deg;C) or less
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                swollen glands
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                vague feeling of bodily discomfort
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
                                                                                        </p>
                                                                                        <p>
                                                                                            <b>
                                                                                                See also:
                                                                                            </b>
                                                                                            <span>
                                                                                                Pneumovax 23 side effects
                                                                                            </span>
                                                                                            (in more detail)
                                                                                        </p>
                                                                                        <br>
                                                                                        <div class="dotline">
                                                                                        </div>
                                                                                        <br>
                                                                                        <p>
                                                                                            The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
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                                                                                        <div class="contentBoxResources">
                                                                                            <br>
                                                                                            <h2>
                                                                                                More Pneumovax 23 resources
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Pneumovax 23 Side Effects
                                                                                                    </span>
                                                                                                    (in more detail)
                                                                                                </li>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Pneumovax 23 Use in Pregnancy &amp; Breastfeeding
                                                                                                    </span>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Pneumovax 23 Drug Interactions
                                                                                                    </span>
                                                                                                </li>
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                                                                                            <br>
                                                                                            <ul>
                                                                                                <li>
                                                                                                    <span class="drugType drugType-pro">
                                                                                                        Pneumovax 23 Prescribing Information
                                                                                                    </span>
                                                                                                    <span>
                                                                                                        (FDA)
                                                                                                    </span>
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    <span class="drugType drugType-mtm">
                                                                                                        Pneumovax 23 Concise Consumer Information
                                                                                                    </span>
                                                                                                    <span>
                                                                                                        (Cerner Multum)
                                                                                                    </span>
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    <span class="drugType drugType-cdi">
                                                                                                        Pneumovax 23 MedFacts Consumer Leaflet
                                                                                                    </span>
                                                                                                    <span>
                                                                                                        (Wolters Kluwer)
                                                                                                    </span>
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="contentBoxCompare">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Compare Pneumovax 23 with other medications
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul class="clearAfter">
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Pneumococcal Disease Prophylaxis
                                                                                                    </span>
                                                                                                </li>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
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                                                                            Tuesday, 11 September 2012
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                                                                                <h3 class="post-title entry-title" itemprop="name">
                                                                                    <a href="https://articlesdirectorynorfolkisland.blogspot.com/2012/09/metyrosine.html">
                                                                                        metyrosine
                                                                                    </a>
                                                                                </h3>
                                                                                <div class="post-header">
                                                                                    <div class="post-header-line-1">
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                                                                                        <br>
                                                                                        <p>
                                                                                            me-TYE-roe-seen
                                                                                        </p>
                                                                                        <br>
                                                                                        <h2>
                                                                                            Commonly used brand name(s)
                                                                                        </h2>
                                                                                        <p>
                                                                                            <b>
                                                                                                In the U.S.
                                                                                            </b>
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Demser
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Available Dosage Forms:
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Capsule
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Therapeutic Class: Antihypertensive
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Pharmacologic Class: Tyrosine Hydroxylase Inhibitor
                                                                                        </p>
                                                                                        <br>
                                                                                        <a id="treatment">
                                                                                        </a>
                                                                                        <h2>
                                                                                            Uses For metyrosine
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            Metyrosine belongs to the general class of medicines called antihypertensives. It is used to treat high blood pressure (hypertension) caused by a disease called pheochromocytoma (a noncancerous tumor of the adrenal gland).
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Metyrosine reduces the amount of certain chemicals in the body. When these chemicals are present in large amounts, they cause high blood pressure.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Metyrosine is available only with your doctor's prescription.
                                                                                        </p>
                                                                                        <br>
                                                                                        <a id="before-using">
                                                                                        </a>
                                                                                        <h2>
                                                                                            Before Using metyrosine
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For metyrosine, the following should be considered:
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Allergies
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            Tell your doctor if you have ever had any unusual or allergic reaction to metyrosine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Pediatric
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            Studies on metyrosine have been done only in adult patients, and there is no specific information comparing use of metyrosine in children with use in other age groups.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Geriatric
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people. There is no specific information comparing use of metyrosine in the elderly with use in other age groups.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Pregnancy
                                                                                        </h3>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <br>
                                                                                        <table>
                                                                                            <tbody>
                                                                                                <tr>
                                                                                                    <th>
                                                                                                    </th>
                                                                                                    <th>
                                                                                                        Pregnancy Category
                                                                                                    </th>
                                                                                                    <th>
                                                                                                        Explanation
                                                                                                    </th>
                                                                                                </tr>
                                                                                                <tr>
                                                                                                    <td>
                                                                                                        All Trimesters
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        C
                                                                                                    </td>
                                                                                                    <td>
                                                                                                        Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
                                                                                                    </td>
                                                                                                </tr>
                                                                                            </tbody>
                                                                                        </table>
                                                                                        <h3>
                                                                                            Breast Feeding
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Interactions with Medicines
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Interactions with Food/Tobacco/Alcohol
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Other Medical Problems
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            The presence of other medical problems may affect the use of metyrosine. Make sure you tell your doctor if you have any other medical problems, especially:
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Kidney disease or
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                Liver disease&mdash;Effects of metyrosine may be increased because of slower removal from the body
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Mental depression (or history of) or
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                Parkinson's disease&mdash;Metyrosine may make these conditions worse
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <h2>
                                                                                            Proper Use of metyrosine
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            Take metyrosine only as directed by your doctor. Do not take more or less of it than your doctor ordered.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            To help you remember to take your medicine, try to get into the habit of taking it at the same times each day.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Dosing
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            The dose of metyrosine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of metyrosine. If your dose is different, do not change it unless your doctor tells you to do so.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
                                                                                        </p>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                For oral dosage forms (capsules):
                                                                                                <br>
                                                                                                <ul>
                                                                                                    <li>
                                                                                                        Adults and children 12 years of age and older: 1000 milligrams to 3000 milligrams (1 to 3 grams) a day, divided into four doses.
                                                                                                    </li>
                                                                                                    <br>
                                                                                                </ul>
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <h3>
                                                                                            Missed Dose
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            If you miss a dose of metyrosine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
                                                                                        </p>
                                                                                        <br>
                                                                                        <h3>
                                                                                            Storage
                                                                                        </h3>
                                                                                        <br>
                                                                                        <p>
                                                                                            Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Keep out of the reach of children.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Do not keep outdated medicine or medicine no longer needed.
                                                                                        </p>
                                                                                        <br>
                                                                                        <a id="safety">
                                                                                        </a>
                                                                                        <h2>
                                                                                            Precautions While Using metyrosine
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            It is important that your doctor check your progress at regular visits to make sure that metyrosine is working properly and to check for unwanted effects.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            While taking metyrosine, it is important that you drink plenty of fluids and urinate often. This will help prevent kidney problems and keep your kidneys working well. If you have any questions about how much you should drink, check with your doctor.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            metyrosine will add to the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; tricyclic antidepressants (medicine for depression); muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are taking metyrosine.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Before having any kind of surgery (including dental surgery), tell the medical doctor or dentist in charge that you are taking metyrosine.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            metyrosine may cause most people to become drowsy or less alert than they are normally. Make sure you know how you react to metyrosine before you drive, use machines, or do anything else that could be dangerous if you are not alert.
                                                                                        </p>
                                                                                        <br>
                                                                                        <a id="side-effects">
                                                                                        </a>
                                                                                        <h2>
                                                                                            metyrosine Side Effects
                                                                                        </h2>
                                                                                        <br>
                                                                                        <p>
                                                                                            Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Check with your doctor as soon as possible if any of the following side effects occur:
                                                                                        </p>
                                                                                        <br>
                                                                                        <i>
                                                                                            More common
                                                                                        </i>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Diarrhea
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                drooling
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                trembling and shaking of hands and fingers
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                trouble in speaking
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <i>
                                                                                            Less common
                                                                                        </i>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Anxiety
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                confusion
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                hallucinations (seeing, hearing, or feeling things that are not there)
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                mental depression
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <i>
                                                                                            Rare
                                                                                        </i>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Black, tarry stools
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                blood in urine or stools
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                unusual bleeding or bruising
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                muscle spasms, especially of neck and back
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                painful urination
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                pinpoint red spots on skin
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                restlessness
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                shortness of breath
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                shuffling walk
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                skin rash and itching
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                swelling of feet or lower legs
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                tic-like (jerky) movements of head, face, mouth, and neck
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                unusual tiredness or weakness
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
                                                                                        </p>
                                                                                        <br>
                                                                                        <i>
                                                                                            More common
                                                                                        </i>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Drowsiness
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <i>
                                                                                            Less common
                                                                                        </i>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Decreased sexual ability in men
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                dryness of mouth
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                nausea, vomiting, or stomach pain
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                stuffy nose
                                                                                            </li>
                                                                                            <br>
                                                                                            <li>
                                                                                                swelling of breasts or unusual milk production
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            After you stop using metyrosine, it may still produce some side effects that need attention. During this period of time,
                                                                                            <i>
                                                                                                check with your doctor immediately
                                                                                            </i>
                                                                                            if you notice the following side effects:
                                                                                        </p>
                                                                                        <br>
                                                                                        <i>
                                                                                            More common
                                                                                        </i>
                                                                                        <br>
                                                                                        <ul>
                                                                                            <li>
                                                                                                Diarrhea
                                                                                            </li>
                                                                                            <br>
                                                                                        </ul>
                                                                                        <p>
                                                                                            Also, after you stop taking metyrosine, you may have feelings of increased energy or you may have trouble sleeping. However, these effects should last only for two or three days.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
                                                                                        </p>
                                                                                        <p>
                                                                                            <b>
                                                                                                See also:
                                                                                            </b>
                                                                                            <span>
                                                                                                metyrosine side effects
                                                                                            </span>
                                                                                            (in more detail)
                                                                                        </p>
                                                                                        <br>
                                                                                        <div class="dotline">
                                                                                        </div>
                                                                                        <br>
                                                                                        <p>
                                                                                            The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
                                                                                        </p>
                                                                                        <br>
                                                                                        <p>
                                                                                            The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
                                                                                        </p>
                                                                                        <div class="contentBoxResources">
                                                                                            <br>
                                                                                            <h2>
                                                                                                More metyrosine resources
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Metyrosine Side Effects
                                                                                                    </span>
                                                                                                    (in more detail)
                                                                                                </li>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Metyrosine Use in Pregnancy &amp; Breastfeeding
                                                                                                    </span>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Metyrosine Drug Interactions
                                                                                                    </span>
                                                                                                </li>
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Metyrosine Support Group
                                                                                                    </span>
                                                                                                </li>
                                                                                                <li style="float: none; clear: left; width: auto;">
                                                                                                    <span>
                                                                                                        0 Reviews for Metyrosine
                                                                                                    </span>
                                                                                                    <span>
                                                                                                        -
                                                                                                        <span rel="nofollow">
                                                                                                            Add your own review/rating
                                                                                                        </span>
                                                                                                    </span>
                                                                                                </li>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="contentBoxMonographs">
                                                                                            <br>
                                                                                            <ul>
                                                                                                <li>
                                                                                                    <span class="drugType drugType-mtm">
                                                                                                        metyrosine Concise Consumer Information
                                                                                                    </span>
                                                                                                    <span>
                                                                                                        (Cerner Multum)
                                                                                                    </span>
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    <span class="drugType drugType-cdi">
                                                                                                        Metyrosine MedFacts Consumer Leaflet
                                                                                                    </span>
                                                                                                    <span>
                                                                                                        (Wolters Kluwer)
                                                                                                    </span>
                                                                                                </li>
                                                                                                <br>
                                                                                                <li>
                                                                                                    <span class="drugType drugType-pro">
                                                                                                        Demser Prescribing Information
                                                                                                    </span>
                                                                                                    <span>
                                                                                                        (FDA)
                                                                                                    </span>
                                                                                                </li>
                                                                                                <br>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
                                                                                        <div class="contentBoxCompare">
                                                                                            <br>
                                                                                            <h2>
                                                                                                Compare metyrosine with other medications
                                                                                            </h2>
                                                                                            <br>
                                                                                            <ul class="clearAfter">
                                                                                                <li>
                                                                                                    <span>
                                                                                                        Pheochromocytoma
                                                                                                    </span>
                                                                                                </li>
                                                                                            </ul>
                                                                                        </div>
                                                                                        <br>
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