PHARMACOKINETICS OF OFLOXACIN IN HEALTHY-SUBJECTS AND PATIENTS WITH VARYING DEGREES OF RENAL IMPAIRMENT

The pharmacokinetics of the new fluoroquinolone antimicrobial ofloxacin were studied in 18 subjects with normal renal function or varying degrees of renal impairment, including patients undergoing continuous ambulatory peritoneal dialysis (CAPD) and haemodialysis. Apparent total body and renal clearances declined and elimination half-life increased with decreasing creatinine clearance. CAPD and haemodialysis removed clinically insignificant fractions of of ofloxacin body burden over the study period (6-15% and 9-11% of the dose, respectively). The apparent volume of distribution, peak concentration, time to peak concentration, and non-renal clearance were not altered significantly by renal insufficiency. An extended dosing interval of 24-48 h is recommended, depending upon the degree of renal impairment, when creatinine clearance falls below 50 mL/min. In addition, supplemental doses would not appear to be necessary during CAPD and following haemodialysis.