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Bromfenac disposition in patients with impaired kidney function
J C Ermer1, J P Boni, W H Cevallos
1Department of Pharmacokinetics, Wyeth-Ayerst Research, Philadelphia, Pa., USA.
Clinical Pharmacology and Therapeutics
|March 1, 1997
Summary
Bromfenac pharmacokinetics did not require dosage adjustments in renally compromised patients. Increased unbound drug fractions were observed, but clearance and volume of distribution remained unchanged, indicating safety for kidney patients.
Area of Science:
- Pharmacology
- Nephrology
- Drug Metabolism
Background:
- Bromfenac is a nonsteroidal anti-inflammatory drug (NSAID).
- Renal impairment can affect drug pharmacokinetics.
- Understanding bromfenac's behavior in kidney disease is crucial for safe prescribing.
Purpose of the Study:
- To compare the pharmacokinetics of bromfenac in healthy individuals versus patients with impaired kidney function and end-stage renal disease.
- To assess the impact of renal compromise on bromfenac's absorption, distribution, metabolism, and excretion.
Main Methods:
- A single 50 mg oral dose of bromfenac was administered to three groups: normal kidney function (18 subjects), decreased kidney function (12 subjects), and dialysis-dependent (10 subjects).
- Pharmacokinetic parameters including peak concentration, area under the curve, clearance, volume of distribution, and half-life were analyzed.
- Protein binding was evaluated using equilibrium dialysis.
Main Results:
- Bromfenac half-life nearly doubled in patients with impaired kidney function and those on dialysis.
- The mean unbound fraction of bromfenac was approximately twice as high in dialysis patients compared to those with normal kidney function.
- No significant differences were observed in clearance or volume of distribution between the groups, even after correcting for the free fraction.
Conclusions:
- No dosage adjustment for bromfenac is necessary in patients with impaired kidney function.
- Despite altered pharmacokinetics, bromfenac appears safe for use in renal impairment.
- Clinical monitoring tailored to the individual patient's condition is recommended.