Comparative Bioavailability of a Generic Phenytoin and Dilantin

David H. Rosenbaum; A. James Rowan; Linda Tuchman; Jacqueline A. French

doi:10.1111/j.1528-1157.1994.tb02487.x

Comparative Bioavailability of a Generic Phenytoin and Dilantin

David H. Rosenbaum, A. James Rowan, Linda Tuchman, Jacqueline A. French

Icahn School of Medicine at Mount Sinai

Research output: Contribution to journal › Article › peer-review

47 Scopus citations

Abstract

Summary: Generic substitution of antiepileptic drugs(AEDs) has been controversial, with many alleged in‐stances of biologic and therapeutic inequivalence re‐ported. The recall of a generic phenytoin (PHT) formula‐tion used in the Veterans Administration (VA) medicalsystem allowed us to evaluate the question of biologicequivalence systematically in a relatively large number ofpatients at the Bronx VA Medical Center. Serum PHTlevels were 22–31% lower during the period of genericintake as compared with levels in the same patients re‐ceiving Dilantin. Review of the literature showed onlyone other adequately documented report of potential clin‐ically significant inequivalence between a brand nameand generic AED. Despite the apparent infrequency ofgeneric inequivalence, several areas in which proceduresfor certification of therapeutic equivalence should be im‐proved were identified.

Original language	English
Pages (from-to)	656-660
Number of pages	5
Journal	Epilepsia
Volume	35
Issue number	3
DOIs	https://doi.org/10.1111/j.1528-1157.1994.tb02487.x
State	Published - May 1994

Keywords

Anticonvulsants
Biologic avail
Drug legislation
Drug stability
Therapeutic equivalence
ability

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10.1111/j.1528-1157.1994.tb02487.x

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Comparative Bioavailability of a Generic Phenytoin and Dilantin

Abstract

Keywords

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