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

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

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. Zonisamid...

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Bibliographic Details
Published in:Journal of clinical pharmacology Vol. 44; no. 11; pp. 1230 - 1234
Main Authors: Levy, René H., Ragueneau-Majlessi, Isabelle, Garnett, William R., Schmerler, Michael, Rosenfeld, William, Shah, Jaymin, Pan, Wei-Jian
Format: Journal Article
Language:English
Published: Oxford, UK Blackwell Publishing Ltd 01-11-2004
SAGE Publications
Subjects:
Adolescent
Adult
Anticonvulsants - pharmacokinetics
Anticonvulsants - pharmacology
Anticonvulsants - therapeutic use
Area Under Curve
Drug Interactions
epilepsy
Epilepsy - blood
Epilepsy - drug therapy
Female
Humans
Isoxazoles - pharmacology
Isoxazoles - therapeutic use
Male
Metabolic Clearance Rate
Middle Aged
pharmacokinetics
phenytoin
Phenytoin - pharmacokinetics
Phenytoin - therapeutic use
Zonisamide
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Summary: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.
Bibliography:istex:2E1770311AB2AB4013B01B0AAE86F464AB946BF7
ArticleID:JCPH981
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ObjectType-Article-1
SourceType-Scholarly Journals-1
ObjectType-Feature-2
content type line 23
ISSN:0091-2700
1552-4604
DOI:10.1177/0091270004268045