Premium
Evaluation of Effects of Terbinafine on Single Oral Dose Pharmacokinetics and Anticoagulant Actions of Warfarin in Healthy Volunteers
Author(s) -
Guerret Madeleine,
Francheteau Patrice,
Hubert Martine
Publication year - 1997
Publication title -
pharmacotherapy: the journal of human pharmacology and drug therapy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.227
H-Index - 109
eISSN - 1875-9114
pISSN - 0277-0008
DOI - 10.1002/j.1875-9114.1997.tb03753.x
Subject(s) - terbinafine , warfarin , pharmacokinetics , placebo , medicine , pharmacodynamics , crossover study , pharmacology , concomitant , anticoagulant , prothrombin time , anesthesia , oral administration , surgery , antifungal , itraconazole , atrial fibrillation , alternative medicine , pathology , dermatology
Study Objective . To evaluate the potential effects of oral terbinafine, a new synthetic antifungal agent of the allylamine class, on the pharmacokinetics and pharmacodynamics of racemic warfarin. Design . Randomized, double‐blind, placebo‐controlled, crossover study. Subjects . Sixteen healthy men. Interventions . Placebo or terbinafine 250 mg was administered once/day for 14 consecutive days, separated by a washout period lasting at least 2 weeks. A single oral dose of racemic warfarin 30 mg was coadministered with placebo or terbinafine on day 8 of each treatment period. Blood samples were collected for 168 hours after administration of warfarin to determine the drug's pharmacokinetics and anticoagulant effects. Measurements and Main Results . No major differences were seen in the plasma concentration‐time profiles of a single dose of warfarin administered with terbinafine or with placebo. Conclusions . Because of the lack of clinically significant interactions between terbinafine and warfarin during multiple‐dose administration of terbinafine, no adjustment of warfarin dosage during concomitant therapy appears to be necessary.