EFFICACY AND SAFETY OF NORFLOXACIN 800 MG ONCE-DAILY VERSUS NORFLOXACIN 400 MG TWICE-DAILY IN THE TREATMENT OF UNCOMPLICATED URINARY-TRACT INFECTIONS IN WOMEN - A DOUBLE-BLIND, RANDOMIZED CLINICAL-TRIAL

Norfloxacin 400 mg twice-a-day has proven to be effective and safe in the treatment of uncomplicated urinary tract infections (UTI). Since p revious pharmacokinetic studies demonstrate the feasibility of using n orfloxacin 800 mg once-daily, and this scheme is assumed to improve pa tient compliance, a double-blind randomized clinical trial was perform ed to compare the efficacy and safety of norfloxacin 800 mg once-daily (Group A) versus norfloxacin 400 mg twice-daily (Group B) in the trea tment of adult female UTI for a 7-10 day period. Eighty-six adult wome n with clinical symptoms and urinary sediment signs suggestive of UTI were enrolled. In Group A, treatment was clinically assessed as effect ive in 95.3% and bacteriologically effective in 92.0% of the patients. In Group B, clinical and bacteriological efficacy was 100% and 95.5%, respectively. Differences between groups are not statistically signif icant. Adverse events were reported by 14.0% of patients in Group A an d 9.6% in Group B (difference not statistically significant), There wa s one withdrawal due to dizziness. In this study, norfloxacin 800 mg o nce-a-day was as effective and safe as norfloxacin 400 mg twice-a-day in the treatment of uncomplicated urinary tract infections in women.