Bromfenac disposition in patients with impaired kidney function.
OBJECTIVE
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.
Ermer
J C
JC
Department of Pharmacokinetics, Wyeth-Ayerst Research, Philadelphia, Pa., USA.
Boni
J P
JP
Cevallos
W H
WH
DeCleene
S
S
Burghart
P
P
Rudnick
M R
MR
Fruncillo
R J
RJ
Berns
J S
JS
Cohen
R M
RM
D000328:Adult; D000368:Aged; D018712:Analgesics, Non-Narcotic / Q000493:pharmacokinetics*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000493:pharmacokinetics*; D001577:Benzophenones / Q000493:pharmacokinetics*; D001969:Bromobenzenes / Q000493:pharmacokinetics*; D005260:Female; D005919:Glomerular Filtration Rate; D006207:Half-Life; D006801:Humans; D007668:Kidney / Q000503:physiopathology*; D007676:Kidney Failure, Chronic / Q000097:blood* / Q000503:physiopathology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D006435:Renal Dialysis
D018712:Analgesics, Non-Narcotic; D000894:Anti-Inflammatory Agents, Non-Steroidal; D001577:Benzophenones; D001969:Bromobenzenes; C053083:bromfenac