Compassionate use of norfloxacin.

Norfloxacin, a new oral fluoroquinolone, has a spectrum of activity and pharmacology that suggest it may be useful in certain infections in which other agents are inactive or have anticipated toxicity. This report is an analysis of 61 "compassionate" requests for norfloxacin that resulted in 42 treatment courses. The reasons for use included multiresistant pathogens susceptible only to norfloxacin in 42 percent, failure of prior use of a marketed antibiotic in 34 percent, and preferred use of norfloxacin due to anticipated toxicity from an aminoglycoside in 32 percent or from other agents in 9 percent. Infections treated included 29 complicated urinary tract infections, 23 involving multiresistant Pseudomonas species, and 10 gastrointestinal infections, seven involving Salmonella species. Prophylaxis of infection was initiated in three neutropenic patients with leukemia. The duration of norfloxacin therapy ranged from eight to 28 days at a daily dose of 800 mg (400 mg twice daily). Norfloxacin treatment resulted in clinical cure or improvement in 84 percent of patients and eradicated the etiologic pathogen(s) 52 percent of the time. In Pseudomonas species infections, cure was achieved in 29 percent of patients and 57 percent showed improvement; the pathogen was eradicated in 43 percent of these infections. Resistance developed in four of the eight Pseudomonas species infections that persisted. Based on a review of compassionate therapy cases, it appears that norfloxacin is effective oral therapy for many complicated urinary and gastrointestinal infections for which other agents cannot be used because of bacterial resistance or anticipated toxicity.