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DRUG INTERACTIONS

Pharmacokinetics and Pharmacodynamics of Warfarin When Coadministered With Pentosan Polysulfate Sodium

Nishit B. Modi, PhD, Sherron Kell, MD, Mary Simon, MS and Ramon Vargas, MD

From ALZA Corp, Mountain View, California (Dr Modi, Dr Kell, Ms Simon) and MDS Pharma Services, New Orleans, Louisiana (Dr Vargas).

The effect of pentosan polysulfate sodium on warfarin pharmacokinetics and pharmacodynamics was investigated in healthy subjects. Warfarin was titrated to an international normalized ratio between 1.4 and 1.8. Subjects continued their titrated dose of warfarin and received pentosan polysulfate sodium 100 mg or placebo every 8 hours for 7 days. The Cmax of R- and S-warfarin was ~840 to 890 ng/mL and 680 to 730 ng/mL, respectively, and was similar in the absence and presence of pentosan polysulfate sodium. The half-life for R- and S-warfarin was 52 to 56 hours and 36 to 40 hours, respectively. Prothrombin time, partial thromboplastin time, and the international normalized ratio for warfarin + placebo and warfarin + pentosan polysulfate sodium were comparable. The AUCINR indicated no treatment effect (P = .772); however, there was a period effect. Analysis of variance for the treatments by period indicated no treatment effect (P > .1). Adverse events were mild and included headache, epistaxis, and rash. Most adverse events were unrelated to treatment and were seen during warfarin titration. Pentosan polysulfate sodium did not affect warfarin pharmacokinetics or pharmacodynamics.

Key Words: Pharmacokinetics • pharmacodynamics • warfarin • pentosan polysulfate sodium

Address for reprints: Nishit B. Modi, PhD, ALZA Corp, Department of Clinical Pharmacology, 1900 Charleston Road, PO Box 7210, Mountain View, CA 94039-7210.


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