Premium
Bromfenac disposition in patients with impaired kidney function
Author(s) -
Ermer James C.,
Boni Joseph P.,
Cevallos William H.,
DeCleene Sheryl,
Burghart Peter,
Rudnick Michael R.,
Fruncillo Richard J.,
Berns Jeffrey S.,
Cohen Raphael M.
Publication year - 1997
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1016/s0009-9236(97)90163-6
Subject(s) - medicine , pharmacokinetics , dialysis , renal function , volume of distribution , kidney disease , kidney , urology , confidence interval , oral administration , impaired renal 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. Results Mean peak concentrations and areas under the concentration versus time curve ranged from 3.3 to 3.9 μg/ml and 5.1 to 6.9 μg · hr/ml, respectively. The mean unbound fraction in the subjects receiving dialysis (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 distribution, or their free fraction‐corrected counterparts. Bromfenac half‐life nearly doubled in the impaired and dialysis groups but was shorter than the anticipated 8‐hour dose interval. Eight subjects had a total of 11 study events; none were serious and all were self‐limited. Conclusions These findings suggest that no dosage adjustment is necessary in patients with impaired kidney function, but clinical monitoring appropriate for their individual condition is recommended. Clinical Pharmacology & Therapeutics (1997) 61 , 312–318; doi: