TUESDAY, Dec. 17, 2002 (HealthDayNews) -- The U.S. Food and Drug Administration has approved an extended-release version of the antibiotic Cipro (ciprofloxacin) to treat uncomplicated urinary tract infections (UTIs).
The recommended dose for the 500-mg. Cipro XR tablet is once daily for three days, Bayer Corp. said in announcing the FDA action. Regular-strength Cipro is normally taken in 250-mg strength twice daily.
UTIs are caused by bacteria that enter the urethra and travel up the urinary tract. Affecting millions of Americans annually, they are the second most common infection, behind those of the respiratory tract. Women are especially prone to UTIs, and their risk increases with age.
FDA approval of Cipro XR followed clinical trials among 891 adult women who had clinical signs of UTI. The study compared the once-daily medication with its older twice-daily counterpart. The company says 95 percent of UTI patients were cured with Cipro XR, versus 93 percent of patients who used regular-strength Cipro.
Cipro XR will begin shipping to U.S. pharmacies on January 2, the company said. Side effects include nausea and headache. The drug should not be taken concurrently with the asthma medication theophylline.
Here is the Bayer Press Release announcing the approval. For more information about urinary tract infections, visit the U.S. National Kidney and Urologic Diseases Information Clearinghouse.