Worldwide clinical experience with ofloxacin in urologic cases

Ofloxacin is a quinolone carboxylic acid with a broad spectrum of activity for gram-negative pathogens that are common causes of urologic infections including cystitis, pyelonephritis, and prostatitis. The data in this publication will review clinical trials in urologic infections as well as the literature which dates from January 1983 through February 1989. The database includes over four hundred reports from nineteen foreign countries and involves data from more than 21,000 patients. The data from the United States were accumulated in clinical trials conducted between 1984 and 1988. Ofloxacin has certain attributes that make it a potentially useful drug in the treatment of urologic infections. These include the high bioavailability from oral administration and the fact that the product is excreted almost entirely by the kidney, primarily as the active parent compound. Urinary levels of ofloxacin two to four hours postadministration can achieve concentrations above 600 micrograms/mL after a single 400-mg dose. Urinary levels twenty-four hours after a single dose are noted to be typically around 50 micrograms/mL. Both of these concentrations are well above the minimum inhibitory concentration (MIC90) for uropathogens, which might be below 1 microgram/mL for many uropathogens. With respect to the prostate, ofloxacin penetrates prostatic tissues well and can achieve concentrations of approximately 4.5 micrograms per gram of prostate tissue as a mean peak level. Prostate levels ten hours postdose will typically be approximately 2.7 micrograms per gram of prostatic tissue. These levels exceed the MIC90 for the majority of prostatic pathogens as well.