Oxcarbazepine Pharmacokinetics and Tolerability in Children With Inadequately Controlled Epilepsy
Identifieur interne : 000D79 ( France/Analysis ); précédent : 000D78; suivant : 000D80Oxcarbazepine Pharmacokinetics and Tolerability in Children With Inadequately Controlled Epilepsy
Auteurs : Rey [France] ; Bulteau [France] ; Motte [France] ; Tran [France] ; Sturm [Suisse] ; D'Souza [États-Unis] ; Markabi [États-Unis] ; Pons [France] ; Dulac [France]Source :
- The Journal of Clinical Pharmacology [ 0091-2700 ] ; 2004-11.
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Abstract
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 t1/2 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.
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DOI: 10.1177/0091270004266617
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