KLACID MR TABLET 500 mg

**4.1 Therapeutic Indications** Klacid® MR 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 4.4 and 5.1** 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. Klacid® MR is also indicated in skin and soft tissue infections of mild to moderate severity, for example folliculitis, cellulitis and erysipelas (see **section 4.4 and 5.1** regarding Sensitivity Testing – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

**4.3. Contraindications** - Hypersensitivity to macrolide antibiotic drugs or any of its excipients (see **section 6.1** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - 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_ (see **section 4.5** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Concomitant administration of clarithromycin and ergot alkaloids (e.g., ergotamine or dihydroergotamine) is contraindicated, as this may result in ergot toxicity (see **section 4.5** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Concomitant administration of clarithromycin and oral midazolam is contraindicated (see **section 4.5** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_) - 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_ (see **sections 4.4 and 4.5** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - 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 (see **section 4.4** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - Clarithromycin (and other strong CYP3A4 inhibitors) should not be used concomitantly with colchicine (see **sections 4.4 and 4.5** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_). - 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 (see **section 4.5** – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_).

ABBOTT LABORATORIES (SINGAPORE ) PRIVATE LIMITED

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