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Home » Drug Information » FDA Approved Drugs » 2000
Medical Areas: Immunology | Pulmonary/Respiratory Diseases | Family Medicine

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Biaxin XL (clarithromycin extended-release tablets)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Company: Abbott Laboratories
Approval Status: Approved March 2000
Treatment Area: Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis

General Information

Biaxin XL Tablets is an extended-release form of the antibiotic Biaxin (clarithromycin). Biaxin XL is indicated for the treatment of:

  • Acute maxillary sinusitis (AMS) caused by
    • Influenzae
    • Catarrhalis
    • Pneumoniae
  • Acute bacterial exacerbation of chronic bronchitis (AECB) caused by
    • Influenzae
    • Parainfluenzae
    • Catarrhalis
    • Pneumoniae

[Biaxin Tablets (non extended-release) are also indicated for pharyngitis/tonsillitis, pneumonia, and uncomplicated skin and skin structure.]

Biaxin XL should be taken with food even though Biaxin Tablets and oral suspension may be taken with or without food.

Clinical Results

94% of patients with Acute Exacerbation of Chronic Bronchitis (AECB) and 97% of patients with Acute Maxillary Sinusitis (AMS) taking Biaxin Tablets in clinical studies were cured or showed significant improvement.

Side Effects

The most common side effects are:

  • Diarrhea (present in 6% of adults taking the medication)
  • Abnormal taste (6%)
  • Nausea (3%)

Discontinuation of treatment due to these adverse events occurred in fewer patients taking Biaxin XL than patients taking Biaxin Tablets.

Post-marketing spontaneously-reported adverse events included:

  • Various allergic reactions
  • Tooth discoloration
  • Alterations of sense of smell (often occurs in conjunction with abnormal taste)
  • Isolated reports of hearing loss (reversible)
  • Various transient central nervous system events (often resolved by discontinuing use of drug)
  • Infrequently reported hepatic dysfunction
  • Rare cases of hypoglycemia

Biaxin XL is contraindicated in patients with allergies to clarithromycin, erythromycin, or any macrolide antibiotic.
Concomitant administration of Biaxin with cisapride, pimozide, or terfenadine is contraindicated. Fatalities due to interactions between clarithromycin and these drugs have been reported.

Clarithromycin should not be administered to pregnant women.

Additional Information

Visit the Abbott Laboratories web site, www.abbott.com, to learn more about Biaxin and about other products, research, and services provided by the company that developed this drug.