section name header

Pronunciation

kla-RITH-roe-mye-sin

Classifications

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

Pharmacologic Classification: macrolides

Indications

REMS


Action

  • Inhibits protein synthesis at the level of the 50S bacterial ribosome.
Therapeutic effects:
  • Bacteriostatic action.

Spectrum:

Pharmacokinetics

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

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Primarily metabolized by the liver via the CYP3A isoenzymes; 10–15% converted by the liver to 14-hydroxyclarithromycin, which has anti-infective activity. 20–30% excreted unchanged in urine.

Half-Life: 250-mg dose: 3–4 hr; 500-mg dose: 5–7 hr.

Time/Action Profile

(plasma concentrations)

ROUTEONSETPEAKDURATION
POunknown2 hr12 hr
PO-XLunknown4 hr24 hr

Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Adv. Reactions/Side Effects

Interactions

Drug-drug:

Route/Dosage

Acute Bacterial Exacerbation of Chronic Bronchitis

Renal Impairment

Acute Maxillary Sinusitis

Renal Impairment

Community-Acquired Pneumonia

Renal Impairment

Uncomplicated Skin/Skin Structure Infections

Renal Impairment

Pharyngitis/Tonsillitis

Renal Impairment

Acute Otitis Media

Renal Impairment

Treatment and Prophylaxis of Disseminated Mycobacterium avium Disease

Renal Impairment

H. pylori Infection

Renal Impairment

Availability

(Generic available)

Assessment

Lab Test Considerations:

Implementation

Patient/Family Teaching

Evaluation/Desired Outcomes

US Brand Names

Biaxin XL

Canadian Brand Names

Biaxin

Code

NDC Code