To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Three-Day Treatment For Bacterial Vaginosis Gets FDA Approval URL: http://www.pslgroup.com/dg/5E98E.htm Doctor's Guide March 3, 1998
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. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. P\S\L shall not be liable for any errors, omissions or delays in this content or any other content on its sites, newsletters or other publications, nor for any decisions or actions taken in reliance on such content. --------------------------------------------------------------------------------------------- This news story was printed from *Doctor's Guide to the Internet* located at http://www.docguide.com --------------------------------------------------------------------------------------- Return to News Story Page This site is maintained by webmaster@pslgroup.com Please contact us with any comments, problems or bugs. All contents Copyright (c) 1998 P\S\L Consulting Group Inc. All rights reserved.