Biaxin XL (clarithromycin extended-release tablets)
Company: Abbott Laboratories
Approval Status: Approved March 2000
Treatment for: Acute Bacterial Exacerbation of Chronic Bronchitis (AECB) and Acute Maxillary Sinusitis
Areas: Immunology/Infectious Diseases; Pulmonary/Respiratory Diseases
| General Information | Clinical Results | Side Effects | Additional Information |
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.
The FDA drug information shown here is licensed from Thomson CenterWatch. The information provided here is for general educational purposes only and does not constitute medical or pharmaceutical advice which should be sought from qualified medical and pharmaceutical advisers.
