BROMFENAC DISPOSITION IN PATIENTS WITH IMPAIRED KIDNEY-FUNCTION

Objectives: To compare the pharmacokinetics of bromfenac among normal subjects and renally compromised patients and patients with end-stage renal disease. Methods: Bromfenac pharmacokinetics were examined after a single 50 mg oral dose in 18 subjects with normal kidney function, 12 subjects with decreased kidney function, and 10 dialysis-dependent subjects. Protein binding was assessed by equilibrium dialysis. Result s: Mean peak concentrations and areas under the concentration versus t ime curve ranged from 3.3 to 3.9 mu g/ml and 5.1 to 6.9 mu g . hr/ml, respectively. The mean unbound fraction in the subjects receiving dial ysis (0.29%) was nearly twice that in the subjects with normal kidney function (0.17%) and in the subjects with impaired kidney function (0. 16%), but no differences were detected in clearance, volume of distrib ution, or their free fraction-corrected counterparts. Bromfenac half-l ife nearly doubled in the impaired and dialysis groups but was shorter than the anticipated 8-hour dose interval. Eight subjects had a total of II study events; none were serious and all were self-limited. Conc lusions: These findings suggest that no dosage adjustment is necessary in patients with impaired kidney function, but clinical monitoring ap propriate for their individual condition is recommended.