Fleroxacin, A new quinolone derivative, against genito-urinary tract infection

We performed a clinical study on fleroxacin, a newly developed quinolone derivative, with the following results. 1. Diffusion into prostatic fluid (PF) The concentration of fleroxacin in PFs, which were collected 1.0-1.5h after a 200 mg administration, ranged from 0.04-0.21 μg/ml (4 specimens from 2 patients). 2. Clinical results Fleroxacin was used in treating 40 patients at doses of 200-600mg a day (400mg, in 2 divided doses, as a rule) for 3-28 days (in many cases 5-14 days). 1) Urinary tract infection (a) Acute uncomplicated cystitis: all five patients, assessed by the Japanese UTI Committee's criteria, were completely cured after 3 day's administration. (b) Chronic complicated diseases: of 21 cases, efficacy in 14 (66.7%) was evaluated as excellent or moderate according to the Japanese UTI Committee's criteria. (c) Genital infection: efficacy in two cases of chronic prostatitis was good and poor. Of two cases of chronic epididymitis (non-chlamydial), the response was good in both after 10-14 day's treatment. 3. Side effects 1) Clinical abnormal values: a transient, mild elevation of BUN and s-Cr was observed in one case. 2) Subjective side effects: there were four cases (six incidences) of side effects probably due to the drug administration: vomiting, headache, disturbed sleep/irritating feeling, and disturbed sleep/light-headed feeling, in one case each. Except in the case of vomiting, administration was continued. After therapy was completed these side effects spontaneously disappeared within 1-2 days. We consider that fleroxacin's long half life (about 10 h) makes it useful in treating UTI and genito-urinary tract infections with once daily administration.