Literature DB >> 15505173

Lower phenytoin serum levels in persons switched from brand to generic phenytoin.

R T Burkhardt1, I E Leppik, K Blesi, S Scott, S R Gapany, J C Cloyd.   

Abstract

After generic phenytoin (PHT) was marketed, the authors identified eight adult patients (ages 34 to 49) whose seizures increased enough to require intervention after switching to generic PHT. The mean total PHT concentration on brand (before generic) was 17.7 +/- 5.3 mg/L, decreased to 12.5 +/- 2.7 mg/L with generic, and increased to 17.8 +/- 3.9 mg/L after brand was re-introduced. Brand and generic PHT do not yield equivalent concentrations in some patients and substitution should not be permitted without physician notification.

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Year:  2004        PMID: 15505173     DOI: 10.1212/01.wnl.0000142091.47698.a2

Source DB:  PubMed          Journal:  Neurology        ISSN: 0028-3878            Impact factor:   9.910


  13 in total

1.  Interchangeability of generic anti-epileptic drugs: a quantitative analysis of topiramate and gabapentin.

Authors:  Marc Maliepaard; Nikola Banishki; Christine C Gispen-de Wied; Steven Teerenstra; André J Elferink
Journal:  Eur J Clin Pharmacol       Date:  2011-04-15       Impact factor: 2.953

2.  The Controversy over Generic Antiepileptic Drugs.

Authors:  Susan J Shaw; Adam L Hartman
Journal:  J Pediatr Pharmacol Ther       Date:  2010-04

3.  Assessing bioequivalence of generic modified-release antiepileptic drugs.

Authors:  Emily L Johnson; Yi-Ting Chang; Barbara Davit; Barry E Gidal; Gregory L Krauss
Journal:  Neurology       Date:  2016-03-25       Impact factor: 9.910

4.  Generic antiepileptic drugs: current controversies and future directions.

Authors:  Michael D Privitera
Journal:  Epilepsy Curr       Date:  2008 Sep-Oct       Impact factor: 7.500

Review 5.  Bioequivalence of antiepileptic drugs: how close is close enough?

Authors:  Barry E Gidal
Journal:  Curr Neurol Neurosci Rep       Date:  2009-07       Impact factor: 5.081

6.  Seizure risk in brain tumor patients with conversion to generic levetiracetam.

Authors:  Terri S Armstrong; Shauna Choi; Julie Walker; Mark R Gilbert
Journal:  J Neurooncol       Date:  2009-11-21       Impact factor: 4.130

7.  Generic antiepileptic drugs.

Authors:  Susan J Shaw; Gregory L Krauss
Journal:  Curr Treat Options Neurol       Date:  2008-07       Impact factor: 3.598

8.  Licensing of Generic Medicines: Are There Any Challenges Left? A Pharmaceutical Regulatory Perspective.

Authors:  John Joseph Borg; Paolo Tomasi; Luca Pani; George Aislaitner; Michal Pirozynski; Hubert Leufkens; Daniela Melchiorri
Journal:  Sci Pharm       Date:  2014-05-22

9.  Substitution of anticonvulsant drugs.

Authors:  Bernhard J Steinhoff; Uwe Runge; Otto W Witte; Hermann Stefan; Andreas Hufnagel; Thomas Mayer; Günter Krämer
Journal:  Ther Clin Risk Manag       Date:  2009-06-22       Impact factor: 2.423

Review 10.  Requirements for generic anti-epileptic medicines: a regulatory perspective.

Authors:  Marc Maliepaard; Yechiel A Hekster; Arnoud Kappelle; Eugène P van Puijenbroek; André J Elferink; Jan Welink; Christine C Gispen-de Wied; Frits J F Lekkerkerker
Journal:  J Neurol       Date:  2009-07-15       Impact factor: 4.849

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