J Clin Pharmacol
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0091270007305504v1
47/10/1320    most recent
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DRUG INTERACTIONS

Ciprofloxacin Prolonged-Release Tablets Do Not Affect Warfarin Pharmacokinetics and Pharmacodynamics

Carla Washington, PhD, S. Y. Eddie Hou, PhD, Nicola C. Hughes, PhD, Corinne Campanella, PharmD and Bret Berner, PhD

From Depomed, Inc, Menlo Park, California (Dr Washington, Dr Berner, Dr Hou) and Biovail Contract Research, Toronto, Ontario, Canada (Dr Hughes, Dr Campanella).

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.

Key Words: Prolonged-release ciprofloxacin • warfarin • drug interactions • pharmacokinetics • pharmacodynamics

Address for correspondence: S. Y. Eddie Hou, PhD, Depomed, Inc, Menlo Park, Calif 94025.


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