FDA approves 5-day regimen for complicated UTI, acute pyelonephritis

October 4, 2007

FDA has approved the use of the 5-day, once-daily regimen of levofloxacin (Levaquin), 750 mg IV and oral, for the treatment of complicated urinary tract infections and acute pyelonephritis.

FDA has approved the use of the 5-day, once-daily regimen of levofloxacin (Levaquin), 750 mg IV and oral, for the treatment of complicated urinary tract infections and acute pyelonephritis.

This approval is based on results of a double-blind, randomized clinical trial involving 1,109 patients with either complicated UTI or acute pyelonephritis that assessed the efficacy and safety of levofloxacin versus ciprofloxacin (Cipro), 400/500 mg twice daily for 10 days. Microbiologic eradication and clinical success rates were similar in both treatment groups, demonstrating the resolution of, or improvement in, urinary symptoms for both the 5- and 10-day regimens.

"The availability of this high-dose, short-course antibiotic regimen provides clinicians with an important tool in the management of complicated UTI and acute pyelonephritis," said Richard David, MD, of the David Geffen School of Medicine at UCLA. "Patients do not always finish a longer course of antibiotics. A shorter course of antibiotic offers patients the convenience of 5-day, once-daily therapy."