J Clin Pharmacol
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First published on August 27, 2007, doi:10.1177/0091270007305504

The Journal of Clinical Pharmacology 2007;47:1320.

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©© 2007 American College of Clinical Pharmacology, Inc.
The Journal of Clinical Pharmacology , 10.1177/0091270007305504

Article

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

Carla Washington 1, S. Y. Eddie Hou 1*, Nicola C. Hughes 2, Corinne Campanella 2, and Bret Berner 1

1 Depomed, Inc
2 Biovail Contract Research

* To whom correspondence should be addressed. E-mail: ehou{at}depomedinc.com.


  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.
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