Home » Drug Information » FDA-Approved Drugs » 2000
Medical Areas: Immunology/Infectious Diseases | Pulmonary/Respiratory Diseases
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Drug Information
The following 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
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.
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.
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.
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.
