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Three-Day Treatment For Bacterial Vaginosis Gets FDA Approval LONDON, ENGLAND -- March 3, 1998 -- The United States Food and Drug Administration has approved Pharmacia & Upjohn’s three-day treatment option for Cleocin Vaginal Cream 2% (clindamycin phosphate) for the treatment of bacterial vaginosis (BV) in non-pregnant women. Cleocin Vaginal Cream is now the only three-day treatment option available to non-pregnant women with BV. The prescription-only product will be available in pharmacies by April 1998. The product was first marketed in the U.S. in 1992, as a seven-day course of therapy. Along with approval of the three-day therapy option, the FDA has also added pregnant women in their third trimester to the population who can be treated with the seven-day treatment option. The three-day treatment option is not recommended for pregnant women with BV. The seven-day treatment option may be used by both pregnant and non-pregnant patients. Bacterial vaginosis is the most common type of vaginal infection in women of reproductive age and accounts for one-third of all vaginal infections. The symptoms include a white vaginal discharge accompanied by an unpleasant odour. The presence of BV can only be diagnosed by a health care professional during a physical examination. Available only by prescription, Cleocin Vaginal Cream three-day treatment option comes in a new 21-gram tube with three disposable applicators. The recommended dose for non-pregnant women is one full applicator inserted intravaginally, at bedtime, for three or seven consecutive days. The existing 40-gram tube with seven disposable applicators will still be available for patients receiving prescriptions for seven-day treatment. Cleocin Vaginal Cream is not recommended for individuals with a history of hypersensitivity to clindamycin, lincomycin or any of the components of the vaginal cream. It should not be used in individuals with a history of regional enteritis, ulcerative colitis or a history of antibiotic-associated colitis. The most common side effects are vaginitis and candida albicans vaginal infections. E-mail this page to a friend or colleague! To print, use this version