GP CLARITHROMYCIN XR FILM-COATED TABLET 500MG

**INDICATIONS & USAGE:** Clarithromycin Extended-Release Tablets USP is indicated for treatment of infections caused by susceptible organisms. Indications include: Lower respiratory tract infections for example, acute and chronic bronchitis, and pneumonia (see section special warnings and clinical pharmacology regarding Sensitivity Testing – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). Upper respiratory tract infections for example, sinusitis and pharyngitis. Clarithromycin Extended-Release Tablets USP is also indicated in skin and soft tissue infections of mild to moderate severity, for example folliculitis, cellulitis and erysipelas (see section special warnings and clinical pharmacology regarding Sensitivity Testing – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

**CONTRAINDICATION:** - Hypersensitivity to macrolide antibiotic drugs or any of its excipients. - Concomitant administration of clarithromycin and any of the following drugs is contraindicated: astemizole, cisapride, pimozide, terfenadine as this may result in QT prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation, and _torsades de pointes_. - Concomitant administration of clarithromycin and ergot alkaloids (e.g., ergotamine or dihydroergotamine) is contraindicated, as this may result in ergot toxicity. - Concomitant administration of clarithromycin and oral midazolam is contraindicated. - Clarithromycin should not be given to patients with history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia, including _torsades de pointes_. - Clarithromycin should not be given to patients with electrolyte disturbances (hypokalemia or hypomagnesaemia, due to the risk of prolongation of the QT-interval). - Clarithromycin should not be used in patients who suffer from severe hepatic failure in combination with renal impairment. - Clarithromycin should not be used concomitantly with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis. - Clarithromycin (and other strong CYP3A4 inhibitors) should not be used concomitantly with colchicine. - As the dose cannot be reduced from 500 mg once-daily, clarithromycin modified release is contraindicated in patients with creatinine clearance less than 30 mL/min. Clarithromycin immediate release tablets may be utilized in this patient population. - Concomitant administration with ticagrelor or ranolazine is contraindicated. - Concomitant administration of clarithromycin and lomitapide is contraindicated

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