Renal tolerance of ofloxacin, a new gyrase inhibitor.

An open study was carried out in 12 male, healthy volunteers to investigate the renal tolerance of ofloxacin, a new, broad-spectrum oral antibacterial agent. Subjects received single doses of 300 mg and then repeated doses of 300 mg ofloxacin twice daily for 7 days. Urine was collected in several fractions during the study and the excretion of creatinine, alanine-aminopeptidase (AAP), gamma-glutamyl transferase (GGT) and n-acetyl-beta-glucose aminidase (NAG) was calculated in 12-hour fractions. Serum creatinine, beta 2-microglobulin concentrations and creatinine clearance were also determined. Based on the findings for the kidney enzymes AAP, GGT and NAG, renal tolerance was good. This was confirmed by creatinine clearance and serum beta 2-microglobulin values. Ofloxacin showed no nephrotoxic potential in this study.