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Titolo:
Effect of food on absorption of Dilantin Kapseals and Mylan extended phenytoin sodium capsules
Autore:
Wilder, BJ; Leppik, I; Hietpas, TJ; Cloyd, JC; Randinitis, EJ; Cook, J;
Indirizzi:
Univ Florida, Coll Med, Dept Neurol & Neurosci, Gainesville, FL 32606 USA Univ Florida Gainesville FL USA 32606 Neurosci, Gainesville, FL 32606 USA Univ Minnesota, Dept Neurol, MINCEP Epilepsy Care, Minneapolis, MN 55455 USA Univ Minnesota Minneapolis MN USA 55455 y Care, Minneapolis, MN 55455 USA Univ Minnesota, Coll Pharm, Dept Expt & Clin Pharmacol, Minneapolis, MN 55455 USA Univ Minnesota Minneapolis MN USA 55455 rmacol, Minneapolis, MN 55455 USA Pfizer Global Res & Dev, Dept Clin Pharmacokinet & Pharmacodynam, Ann Arbor, MI USA Pfizer Global Res & Dev Ann Arbor MI USA harmacodynam, Ann Arbor, MI USA
Titolo Testata:
NEUROLOGY
fascicolo: 4, volume: 57, anno: 2001,
pagine: 582 - 589
SICI:
0028-3878(20010828)57:4<582:EOFOAO>2.0.ZU;2-X
Fonte:
ISI
Lingua:
ENG
Soggetto:
GENERIC PHENYTOIN; PLASMA-LEVELS; BIOAVAILABILITY; ANTACIDS; FORM;
Tipo documento:
Article
Natura:
Periodico
Settore Disciplinare:
Clinical Medicine
Life Sciences
Citazioni:
43
Recensione:
Indirizzi per estratti:
Indirizzo: Wilder, BJ Univ Florida, Coll Med, Dept Neurol & Neurosci, 10530 NW 15th Pl, Gainesville, FL 32606 USA Univ Florida 10530 NW 15th Pl Gainesville FL USA 32606 2606 USA
Citazione:
B.J. Wilder et al., "Effect of food on absorption of Dilantin Kapseals and Mylan extended phenytoin sodium capsules", NEUROLOGY, 57(4), 2001, pp. 582-589

Abstract

Background: Because of phenytoin's narrow therapeutic index and nonlinear pharmacokinetics, food-induced alterations in absorption may markedly influence drug concentrations and, in turn, safety and effectiveness. Potential food-associated differences between 100-mg Mylan (Mylan Pharmaceuticals) extended-release phenytoin sodium capsules and Parke-Davis 100-mg Dilantin Kapseals were examined. Methods: A single-dose, two-way crossover study was conducted in 24 healthy subjects to determine the effect of a high-fat meal on the pharmacokinetics of both formulations. Pharmacokinetic parameters were estimated by noncompartmental methods. The impact of switching products on steady-state phenytoin concentrations was investigated through simulation using pharmacokinetic data previously obtained from 30 epileptic patients. Results: Based on AUC(0-infinity), bioavailability of the Mylan product administered with food was 13% lower than that observed with Dilantin Kapseals. Simulations of substituting the Mylan product for Dilantin suggested that the 13% decrease in bioavailability would result in a median 37%, decrease (range 19 to 58%) in plasma phenytoin concentrations when the drug is given with food; in 46%, of patients, phenytoin concentrations would likely fall below the therapeutic range of 10 to 20 mg/L. Simulations of substituting Dilantin for the Mylan product suggested that the 15% increase in bioavailability would result in a median 102% increase (range 24 to > 150%) in plasma phenytoin concentrations, with 84% of patients having phenytoin concentrations above the therapeutic range. Conclusions: Results suggest that when taking phenytoin sodium with food, product switches may result in either side effects or loss of seizure control.

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Documento generato il 04/04/20 alle ore 02:44:14