To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: New Prescription Treatment Available For Uncomplicated Urinary Tract Infection URL: http://www.pslgroup.com/dg/D57F2.htm Doctor's Guide December 21, 1998
RARITAN, NJ -- Dec. 21, 1998 -- The United States Food and Drug Administration has approved a new indication for Levaquin(R) Tablets/Injection (levofloxacin tablets/injection) to include the treatment of uncomplicated urinary tract infection. The new indication is for short-course therapy with Levaquin once-daily for three days in the treatment of mild to moderate uncomplicated urinary tract infection (acute cystitis) in women caused by the organisms Escherichia coli, Klebsiella pneumoniae, or Staphylococcus saprophyticus. Since its U.S. introduction in 1996, Levaquin has gained widespread use in the treatment of adults with mild to moderate complicated urinary tract infections and acute pyelonephritis, as well as community-acquired pneumonia, acute maxillary sinusitis and acute exacerbation of chronic bronchitis. Infections of the urinary tract are common -- only respiratory infections occur more frequently, according to the National Institutes of Health (NIH). Each year, urinary tract infections account for about eight million doctor visits and one in five women develops a UTI during her lifetime, according to the NIH. The most common symptoms of the condition are a frequent urge to urinate and a painful, burning feeling in the area of the urethra during urination. Levaquin was studied for the treatment of urinary tract infection in a double-blind multicentre trial, in which 545 subjects were assigned randomly to three days of levofloxacin 250 mg once-daily or Ortho-McNeil's Floxin(R) Tablets/I.V. (ofloxacin tablets/injection) 200 mg twice-daily. The study found that 96.4 percent of all pathogens were eradicated in the levofloxacin group, compared with 94.8 percent for ofloxacin. Symptoms were cured or improved in 98.1 percent of subjects receiving levofloxacin and in 97 percent of those receiving ofloxacin. Drug-related side effects occurred in 3.4 percent of subjects receiving levofloxacin and in 7.5 percent of those receiving ofloxacin. Floxin is indicated for the treatment of uncomplicated cystitis due to Escherichia coli or Klebsiella pneumoniae. In addition, compliance with the three-day regimen was excellent: 95.6 percent in the levofloxacin group and 94.9 percent in the ofloxacin group received all three days of therapy, as prescribed. The safety and efficacy of both levofloxacin and ofloxacin in pediatric patients, adolescents (under 18), pregnant women and nursing women have not been established. Levofloxacin and ofloxacin are contraindicated in persons with a history of hypersensitivity to either drug, quinolone antimicrobial agents, or any other components of the products. Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including levofloxacin and ofloxacin. These reactions often occur following the first dose. The drug should be discontinued immediately at the first appearance of a skin rash or any other sign of hypersensitivity. Related Links: Levaquin --------------------------------------------------------------------------------------------- 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.