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S.C. Sandoz S.R.L.
[Natrapharm]
Regulatory Class: Rx
C: Clarithromycin
I: Upper resp tract eg, tonsillitis/pharyngitis, lower resp tract eg, community acquired pneumonia & skin & soft tissue infections of mild to moderate severity. Acute otitis media in childn. Sinusitis & acute exacerbation of chronic bronchitis in adult & adolescents >12 yr. Eradication of H. pylori in adult w/ H. pylori associated ulcers.
D: Adult & adolescent 250 mg bid, may be increased to 500 mg bid in severe infections. Duration of treatment: 6-14 days. Adult Elimination of H. pylori Clarithromycin 500 mg bid + amoxicillin 1,000 mg bid + omeprazole 20 mg bid for 7 days. Renal impairment CrCl <30 mL/min 250 mg daily or 250 mg bid in most severe infections. Duration of treatment: Do not exceed 14 days. Childn 6 mth- 12 yr 7.5 mg/kg bid. Childn 8-12 yr 10 mL bid for up to 5-10 days, 4-8 yr 7.5 mL bid, 2-4 yr, 5 mL bid, 1-2 yr 2.5 mL bid. Renal impairment CrCl <30 mL/min 7.5 mg/kg once daily. Duration of treatment: Do not exceed 14 days. Strep pyogenes infections Duration of therapy: At least 10 days.
A:
CI: Hypersensitivity to clarithromycin or macrolides. Concomitant use w/ astemizole, cisapride, domperidone, pimozide, terfenadine, ticagrelor or ranolazine, ergot alkaloids (eg, ergotamine or dihydroergotamine), HMG-CoA reductase inhibitors (lovastatin or simvastatin), colchicine, oral midazolam. Patients w/ history of QT prolongation (congenital or documented acquired QT prolongation) or ventricular cardiac arrhythmia including torsade de pointes. Hypokalemia. Severe hepatic failure in combination w/ renal impairment.
SP: Hepatic dysfunction including increased liver enzymes & hepatocellular &/or cholestatic jaundice w/ or w/o jaundice. Patients w/ preexisting hepatic disease or those taking other hepatotoxic medicinal products. Clostridium difficile-associated diarrhea. Avoid use of medicinal products that inhibits peristalsis. Patients w/ CAD, severe cardiac insufficiency, conduction disturbances or clinically relevant bradycardia; electrolyte disturbances eg, hypomagnesemia. Should not be given to patient w/ hypokalemia. Short term risk of arrhythmia, MI & CV mortality. Perform sensitivity testing when prescribing for community-acquired pneumonia & skin & soft tissue infections of mild to moderate severity. Discontinue immediately in the event of severe acute hypersensitivity reactions eg, anaphylaxis, severe cutaneous adverse reactions, Stevens-Johnson syndrome, toxic epidermal necrolysis & drug rash w/ eosinophilia & systemic symptoms. Monitor for signs & symptoms of myopathy. Monitor glucose when in concomitant use w/ sulphonylureas. Frequently monitor INR & prothrombin time when in concurrent use w/ oral anticoagulants. Colonisation w/ increased numbers of non-susceptible bacteria & fungi on long-term use. Concomitant use w/ triazolobenzodiazepenes eg, triazolam & IV or oromucosal midazolam; other medicinal products associated w/ QT prolongation; cytochrome CYP3A4 inducers. Visual impairment & vision blurred may affect ability to drive or operate machinery. Moderate to severe renal impairment & impaired hepatic function. Pregnancy.
