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| |  FDA Approves Extended-Release Biaxin (Clarithromycin) For Acute Sinusitis ABBOTT PARK, IL -- March 7, 2000 -- Abbott Laboratories announced it has received U.S. Food and Drug Administration (FDA) approval to market Biaxin XL(R) (clarithromycin extended-release tablets), a new, once-daily formulation of its widely-prescribed advanced-generation macrolide antibiotic, Biaxin(R) (clarithromycin) tablets. Biaxin XL will be available in pharmacies nationwide in April. "We are pleased to introduce a convenient and very well-tolerated formulation of an important antibiotic," said Ed Fiorentino, vice president, commercial operations, Pharmaceutical Products Division at Abbott Laboratories. "Biaxin XL reflects our ongoing commitment to research and development of new products that meet the needs of patients and physicians." Biaxin XL tablets are indicated for the treatment of mild-to-moderate acute maxillary sinusitis (AMS) caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae, and acute bacterial exacerbation of chronic bronchitis (AECB) caused by Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. The most frequently reported adverse events in adults taking Biaxin XL tablets were diarrhea (6 percent), abnormal taste (6 percent), and nausea (3 percent). Most of these events were described as mild to moderate in severity. Although the gastrointestinal-related adverse events were similar in patients taking Biaxin XL tablets versus Biaxin tablets, fewer discontinuations due to gastrointestinal events or abnormal taste occurred in patients taking Biaxin XL tablets. As in patients taking Biaxin tablets, for patients with a known hypersensitivity to clarithromycin or any macrolide antibiotic, Biaxin XL tablets are contraindicated. Concomitant administration with Propulsid(R)(cisapride), Orap(R)(pimozide), or Seldane(R)(terfenadine) is contraindicated. Biaxin XL tablets should not be used in pregnant women except in circumstances for which no alternative therapy is appropriate. Biaxin XL tablets may elevate digoxin serum concentration. Serum digoxin levels should be carefully monitored while digoxin and clarithromycin are taken concomitantly. The dose of clarithromycin should be halved or the dosing interval doubled in patients with severe renal impairment (CrCl less than 30mL/minute). Related Links: Biaxin (clarithromycin) and Abbott Laboratories.
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