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| |  Once-Daily Biaxin XL (Clarithromycin) Available In US For Sinusitis And Chronic Bronchitis ABBOTT PARK, IL -- April 26, 2000 -- There's good news for people with certain respiratory infections who require antibiotics -- but don't like the inconvenience of multiple daily dosing. Abbott Laboratories announced the availability of Biaxin(R) XL (clarithromycin extended-release tablets), a new, once-daily formulation of its widely-prescribed advanced-generation macrolide antibiotic, Biaxin(R) (clarithromycin) tablets. Biaxin XL is now available in pharmacies nationwide. "Biaxin XL is an important enhancement in the treatment of acute maxillary sinusitis and acute exacerbation of chronic bronchitis, combining proven efficacy equivalent to the original Biaxin tablet with the convenience of a once-daily formulation," said Mark Gotfried, M.D., adjunct associate professor at the University of Illinois at Chicago. "For patients with these conditions who face the challenge of working multiple daily doses into their busy schedules, Biaxin XL offers a new treatment option requiring half the daily doses compared with the original formulation." In studies with healthy subjects, once-daily dosing with Biaxin XL provided equivalent drug absorption compared to the original twice-daily formulation of Biaxin. Biaxin XL tablets are indicated for mild to moderate infections in adults for the treatment of acute maxillary sinusitis (AMS) and acute bacterial exacerbation of chronic bronchitis (AECB). In adult clinical trials, Biaxin XL tablets taken once daily resulted in clinical cure rates comparable to that of the original formulation taken twice daily in both AMS caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae, and AECB caused by Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. The efficacy and safety of Biaxin XL in treating other infections for which other formulations of Biaxin are approved have not been established. The most frequently reported adverse events with Biaxin XL tablets were diarrhea (6 percent), abnormal taste (6 percent), and nausea (3 percent). 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. In 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 due to the potential for cardiac arrhythmias. 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 < 30mL/minute). "We are pleased to introduce a more convenient and very well-tolerated formulation of an important antibiotic," said Ed Fiorentino, vice president, Commercial Operations at Abbott Laboratories. "Biaxin XL reflects our ongoing commitment to research and development of new products that meet the needs of patients and physicians." Abbott Laboratories has a long history of leadership in anti-infectives dating back to the 1930's. Abbott was one of the five pioneers in the United States to start commercial production of penicillin. Years later, in conjunction with the research efforts of two other pharmaceutical companies, Abbott developed an early macrolide antibiotic. In addition, Abbott also markets a cephalosporin antibiotic and recently signed a global licensing agreement with Wakunaga Pharmaceutical to develop and market two investigational anti-infective compounds. Abbott's commitment continues today with extensive research to discover and develop new compounds in this area. Please see full prescribing information for Biaxin. Abbott Laboratories is a global, diversified healthcare company devoted to the discovery, development, manufacture and marketing of pharmaceutical, diagnostic, nutritional and hospital products. The company employs 57,000 people and markets its products in more than 130 countries. Related Links: Biaxin XL (clarithromycin extended-release tablets) and Abbott Laboratories.
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