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Oxcarbazepine Pharmacokinetics and Tolerability in Children With Inadequately Controlled Epilepsy

From the Hôpital St. Vincent de Paul, Paris, France (Dr. Rey, Dr. Bulteau, Dr. Tran, Dr. Pons, Dr. Dulac); Hôpital Americain, Reims, France (Dr. Motte); Novartis Pharma AG, Basel, Switzerland (Dr. Sturm); and Novartis Pharmaceuticals Corporation, East Hanover, New Jersey (Dr. D'Souza, Dr. Markabi).

This two-part, open-label study evaluated the pharmacokinetics, safety, and tolerability of oxcarbazepine as combination therapy in 112 children 2 to 12 years old with inadequately controlled epilepsy. Part I was a pharmacokinetic study in children stratified by age (2-5 years and 6-12 years) and randomized to receive a single oxcarbazepine dose of 5 mg/kg or 15 mg/kg. Mean specific AUC and t_1/2 values of the active metabolite (MHD) were approximately 30% lower in younger children compared with older children, regardless of dose. Part II was a 4-month safety, tolerability, and pharmacokinetic study in which children received oxcarbazepine doses of 11 to 68 mg/kg/day. The mean specific oxcarbazepine daily dose was 38% higher in younger children compared with older children. Similarly, mean trough plasma MHD concentrations were 34% lower in younger children. Six (5%) children discontinued due to adverse events. Oxcarbazepine was safe and well tolerated. Younger children require higher oxcarbazepine doses because of rapid clearance.

Key Words: Oxcarbazepine • pharmacokinetics • safety • tolerability • inadequately controlled epilepsy • pediatrics • antiepileptic drugs

Address for reprints: Elisabeth Rey, PharmD, Hôpital St. Vincent de Paul, 74, Avenue Denfert-Rochereau, 75 674 Paris Cedex 14, France.

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				J. E. Pina-Garza, R. Espinoza, D. Nordli, D. A. Bennett, S. Spirito, T. E. Stites, D. Tang, and Y. Sturm Oxcarbazepine adjunctive therapy in infants and young children with partial seizures Neurology, November 8, 2005; 65(9): 1370 - 1375. [Abstract] [Full Text] [PDF]