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Indications

REMS

Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects

CV: QT interval prolongation, TORSADES DE POINTES.

Derm: ACUTE GENERALIZED EXANTHEMATOUS PUSTULOSIS, DRUG RASH WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), pruritus, rash, STEVENS-JOHNSON SYNDROME, TOXIC EPIDERMAL NECROLYSIS.

GI: CLOSTRIDIOIDES DIFFICILE-ASSOCIATED DIARRHEA (CDAD), abdominal pain/discomfort, abnormal taste, diarrhea, dyspepsia, HEPATOTOXICITY, nausea.

Neuro: headache.

Misc: HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA).

Interactions

Drug-Drug:

Availability

(Generic available)

Route/Dosage

see Calculator

Renal Impairment

  • PO (Adults): CCr <30 mL/min: 250 mg 1–2 times daily, a 500-mg initial dose may be used.
  • PO (Children): CCr <30 mL/min: ↓ dose by 50% or double dosing interval.

US Brand Names

Biaxin XL

Action

Therapeutic Effects:

Spectrum:

Classifications

Therapeutic Classification: agents for atypical mycobacterium, anti-infectives, antiulcer agents

Pharmacologic Classification: macrolides

Pharmacokinetics

Absorption: Rapidly absorbed (50%) after oral administration.

Distribution: Widely distributed; tissue levels may exceed those in serum.

Protein Binding: 65–70%.

Metabolism/Excretion: 10–15% converted by the liver to 14-hydroxyclarithromycin, which has anti-infective activity; 20–30% excreted unchanged in urine. Metabolized by and also inhibits the CYP3A enzyme system.

Half-life: Dose-dependent and prolonged with renal dysfunction 250-mg dose: 3–4 hr; 500-mg dose: 5–7 hr.

Canadian Brand Names

Biaxin

Time/Action Profile

(plasma concentrations)

ROUTEONSETPEAKDURATION
POunknown2 hr12 hr
PO-XLunknown4 hr24 hr

Patient/Family Teaching

Pronunciation

kla-RITH-roe-mye-sin audio

Code

NDC Code*