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Clarithromycin

    Brands

    DEA Class; Rx

    Common Brand Names; Biaxin, Biaxin XL

    • Macrolides

    Oral macrolide antibiotic; penetrates lung tissue and macrophages to a greater degree than erythromycin; used for respiratory tract infections, STDs, otitis media, and MAC in AIDS patients; used in combination regimens for H. pylori eradication.

    Indicated for treatment of mild-to-moderate infections caused by susceptible isolates caused by Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae

    Indicated for the treatment of mild-to-moderate infections caused by susceptible isolates caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae

    Indicated treatment and prophylaxis of mycobacterial infections

    Indicated for H pylori eradication when treating patients with active or history of peptic ulcer disease

    Indicated for the treatment of mild-to-moderate infections caused by susceptible isolates caused by Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Mycoplasma pneumoniae, Streptococcus pneumoniae, or Chlamydophila pneumoniae

    Used off-label for treatment of pertussis or for postexposure prophylaxis

    Used off-label for bacterial endocarditis prophylaxis

    Documented hypersensitivity

    Coadministration with pimozide, cisapride, ergotamine, and dihydroergotamine

    History of cholestatic jaundice or hepatic dysfunction associated with previous use of clarithromycin

    Coadministration with colchicine in patients with renal or hepatic impairment

    Coadministration with HMG-CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin, simvastatin), due to the increased risk of myopathy, including rhabdomyolysis

    • Gastrointestinal (GI) effects, general (13%)
    • Abnormal taste (adults, 3-7%)
    • Diarrhea (3-6%)
    • Nausea (adults, 3-6%)
    • Vomiting (adults, 1%; children, 6%)
    • Elevated blood urea nitrogen (BUN; 4%)
    • Abdominal pain (adults, 2%; children, 3%)
    • Rash (children, 3%)
    • Dyspepsia (2%)
    • Heartburn (adults, 2%)
    • Headache (2%)
    • Elevated prothrombin time (PT; 1%)

    Acute hypersensitivity reactions; discontinue immediately if severe hypersensitivity reactions occur (eg, anaphylaxis, Stevens-Johnson syndrome, TEN, drug reaction with eosinophilia and systemic symptoms [DRESS] syndrome, Henoch-Schonlein purpura)

    Associated with QT interval prolongation and infrequent cases of arrhythmias, including torsade de pointes; avoid using with ongoing proarrhythmic conditions (eg, uncorrected hypokalemia or hypomagnesemia), clinically significant bradycardia; patients aged ≥65 yr may be more susceptible to drug-associated QT prolongation (also see Drug Interaction Overview)

    Hepatic dysfunction, including increased liver enzyme activity and hepatocellular or cholestatic hepatitis, with or without jaundice, have been reported; this may be severe and is usually reversible

    Discontinue clarithromycin immediately if signs and symptoms of hepatitis occur (eg, anorexia, jaundice, dark urine, pruritus, tender abdomen)

    May increase morbidity among patients with coronary heart disease who received a 2-week course of clarithromycin; in an observational study, this risk became apparent after patients had been followed for ≥1 year; based on this study, the FDA added a warning to the prescribing information (CLARICOR trial; BMJ 2006;332:22-7)

    Clostridium difficile associated diarrhea reported with use of nearly all antibacterial agents, including clarithromycin

    Not for use in pregnancy, except when there is no alternative therapy; apprise patient about potential hazard to fetus if pregnancy occurs while in therapy

    Exacerbation of myasthenia gravis or new onset of symptoms reported

    Based on findings from animal studies, drug is not recommended for use in pregnant women except in clinical circumstances where no alternative therapy is appropriate; if pregnancy occurs while taking drug, patient should be apprised of potential hazard to fetus

    Based on limited human data, clarithromycin and its active metabolite 14-OH clarithromycin are present in human milk at less than 2% of the maternal weight-adjusted dose

    Adults

    1.5 g/day PO (immediate-release formulations); 1 g/day PO (extended-release formulation).

    Geriatric

    1.5 g/day PO (immediate-release formulations); 1 g/day PO (extended-release formulation).

    Adolescents

    15 mg/kg/day PO is FDA-approved maximum; however, doses up to approximately 30 mg/kg/day (Max: 1 g/day) PO have been used off-label for H. pylori eradication (immediate-release formulations only).

    Children

    15 mg/kg/day PO is FDA-approved maximum; however, doses up to approximately 30 mg/kg/day (Max: 1 g/day) PO have been used off-label for H. pylori eradication (immediate-release formulations only).

    Infants

    6 to 11 months: 15 mg/kg/day PO (immediate-release formulations only).
    1 to 5 months: Safety and efficacy have not been established; however, up to 15 mg/kg/day PO (immediate-release formulations only) has been used off-label.

    Neonates

    Safety and efficacy have not been established.

    Clarithromycin

    oral suspension

    • 125mg/5mL
    • 250mg/5mL

    tablet

    • 250mg
    • 500mg

    tablet, extended release

    • 500mg