title: Ciprofloxacin prolonged-release tablets do not affect warfarin pharmacokinetics and pharmacodynamics.
abstract: The purpose of this study was to determine whether the pharmacokinetics of warfarin and ciprofloxacin PR (a prolonged-release formulation of ciprofloxacin) were altered after coadministration. Eighteen healthy male volunteers were given a single oral 7.5-mg dose of warfarin, a single oral 500-mg dose of ciprofloxacin PR, or both drugs administered together in a randomized, open-label, 3-way crossover study. Ciprofloxacin concentrations, warfarin (R)- and (S)-enantiomer concentrations, prothrombin time, and activated partial thromboplastin time were measured over 120 hours following study drug administration. There were no significant differences in pharmacokinetic or pharmacodynamic parameters among treatments. A slightly greater value of half-life for (R)-warfarin was observed when coadministered with ciprofloxacin PR compared with warfarin administered alone (52.6 vs 50.1 hours, P = .029). This difference is not considered clinically relevant, because the values remain similar. These results show that warfarin pharmacokinetics and pharmacodynamics are not altered with concomitant administration of ciprofloxacin PR.
authors.affiliation: Depomed Inc., Menlo Park, CA 94025, USA.
authors.forename: Carla
authors.initials: C
authors.lastname: Washington
authors.forename: S Y Eddie
authors.initials: SY
authors.lastname: Hou
authors.forename: Nicola C
authors.initials: NC
authors.lastname: Hughes
authors.forename: Corinne
authors.initials: C
authors.lastname: Campanella
authors.forename: Bret
authors.initials: B
authors.lastname: Berner
mesh_terms: D000293:Adolescent; D000328:Adult; D000704:Analysis of Variance; D000890:Anti-Infective Agents / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000494:pharmacology; D000925:Anticoagulants / Q000493:pharmacokinetics / Q000494:pharmacology; D002939:Ciprofloxacin / Q000008:administration & dosage / Q000493:pharmacokinetics / Q000494:pharmacology; D018592:Cross-Over Studies; D003692:Delayed-Action Preparations; D004347:Drug Interactions; D006207:Half-Life; D006801:Humans; D008297:Male; D008875:Middle Aged; D010314:Partial Thromboplastin Time; D011517:Prothrombin Time; D013237:Stereoisomerism; D013607:Tablets; D014859:Warfarin / Q000493:pharmacokinetics / Q000494:pharmacology
chemical_list: D000890:Anti-Infective Agents; D000925:Anticoagulants; D003692:Delayed-Action Preparations; D013607:Tablets; D002939:Ciprofloxacin; D014859:Warfarin