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Evaluation of Pharmacokinetic Interaction Between Bromfenac and Phenytoin in Healthy Males
Author(s) -
GumbhirShah Kavita,
Cevallos William H.,
DeCleene Sheryl A.,
KorthBradley Joan M.
Publication year - 1997
Publication title -
the journal of clinical pharmacology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.92
H-Index - 116
eISSN - 1552-4604
pISSN - 0091-2700
DOI - 10.1002/j.1552-4604.1997.tb04775.x
Subject(s) - phenytoin , pharmacokinetics , medicine , pharmacokinetic interaction , pharmacology , drug interaction , epilepsy , anesthesia , psychiatry
An open‐label, nonrandomized, multiple‐dose, inpatient study was conducted in healthy male volunteers to compare the pharmacokinetics of bromfenac and phenytoin when the drugs are given individually and concomitantly. Twelve men received multiple oral doses of bromfenac for 4 days and then oral phenytoin for up to 14 days followed by concomitant administration of bromfenac and phenytoin for 8 days. Concomitant administration of the two drugs caused an approximate 40% decrease in the mean peak plasma concentration (C max ) and the interdose area under the concentration—time curve (AUC) of bromfenac. The oral clearance (Cl po ) of bromfenac doubled and the volume of distribution increased by 77%. For phenytoin, the mean peak serum concentration and the AUC increased by 9% and 11%, respectively, in the presence of bromfenac. The only change in unbound phenytoin was a 16% increase in the AUC. Although statistically significant, the changes in the pharmacokinetic parameters of phenytoin and unbound phenytoin were small. Adjustments in the dose of phenytoin should not be required during concomitant administration of bromfenac, although each patient's clinical status should be evaluated individually.