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DRUG INTERACTIONS

Lack of a Clinically Significant Effect of Zonisamide on Phenytoin Steady-State Pharmacokinetics in Patients With Epilepsy

René H. Levy, PhD, Isabelle Ragueneau-Majlessi, MD, William R. Garnett, PharmD, Michael Schmerler, MD, William Rosenfeld, MD, Jaymin Shah and Wei-Jian Pan

From the Department of Pharmaceutics, University of Washington, Seattle, Washington (Dr Levy, Dr Ragueneau-Majlessi); Virginia Commonwealth University, Medical College of Virginia, Richmond, Virginia (Dr Garnett); Riverhills Healthcare, Inc, Cincinnati, Ohio (Dr Schmerler); Comprehensive Epilepsy Care Center for Children and Adults, Chesterfield, Missouri (Dr Rosenfeld); Gilead Sciences, Inc, Foster City, California (Dr Shah, formerly at Elan Pharmaceutical, Inc); and Elan Pharmaceuticals, Inc, San Diego, California (Dr Pan).

This study was designed to measure the effect of the addition of zonisamide on phenytoin pharmacokinetics under steady-state conditions in patients with epilepsy. Nineteen patients stabilized under phenytoin monotherapy were included in a 3-center, open-label, 1-way drug interaction trial. Zonisamide was gradually increased to 400 mg/day, taken twice daily. Three pharmacokinetic profiles were performed: on days -7 and -1, to assess pharmacokinetic parameters of oral phenytoin administered alone, and on day 35, after 14 days of zonisamide treatment, to evaluate the effect of zonisamide on phenytoin pharmacokinetics and to characterize zonisamide pharmacokinetics in the presence of phenytoin. Fourteen patients completed the study; the coadministration of zonisamide and phenytoin was safe and well tolerated. Zonisamide did not significantly affect the mean Cmin, Cmax, AUC0-12, and CL/F of phenytoin measured before and after zonisamide administration. The pharmacokinetic measures of zonisamide in the presence of phenytoin were consistent with previous reports of induction of zonisamide metabolism by phenytoin.

Key Words: Zonisamide • phenytoin • pharmacokinetics • epilepsy • drug interactions

Address for reprints: Dr René H. Levy, University of Washington, H-272N Health Sciences, Box 357610, Seattle, WA 98195.


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