Classes
DEA Class; Rx
Common Brand Names; Biaxin, Biaxin XL
- Macrolides
Description
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.
Indications
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
Contraindications
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
Adverse Effects
- 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%)
Warnings
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
Pregnancy and Lactation
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
Maximum Dosage
1.5 g/day PO (immediate-release formulations); 1 g/day PO (extended-release formulation).
1.5 g/day PO (immediate-release formulations); 1 g/day PO (extended-release formulation).
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).
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).
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.
Safety and efficacy have not been established.
How supplied
Clarithromycin
oral suspension
- 125mg/5mL
- 250mg/5mL
tablet
- 250mg
- 500mg
tablet, extended release
- 500mg
