Bromfenac disposition in patients with impaired kidney function.

Autor: Ermer JC; Department of Pharmacokinetics, Wyeth-Ayerst Research, Philadelphia, Pa., USA., Boni JP, Cevallos WH, DeCleene S, Burghart P, Rudnick MR, Fruncillo RJ, Berns JS, Cohen RM
Jazyk: angličtina
Zdroj: Clinical pharmacology and therapeutics [Clin Pharmacol Ther] 1997 Mar; Vol. 61 (3), pp. 312-8.
DOI: 10.1016/S0009-9236(97)90163-6
Abstrakt: 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 micrograms/ml and 5.1 to 6.9 micrograms.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.
Databáze: MEDLINE
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