Oxcarbazepine Pharmacokinetics and Tolerability in Children With Inadequately Controlled Epilepsy

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 ra...

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Bibliographic Details
Published in:Journal of clinical pharmacology 2004-11, Vol.44 (11), p.1290-1300
Main Authors: Rey, Elisabeth, Bulteau, Christine, Motte, Jacques, Tran, Agnes, Sturm, Yvonne, D'Souza, Joseph, Markabi, Sabri, Pons, Gérard, Dulac, Olivier
Format: Article
Language:English
Subjects:
Anticonvulsants - adverse effects
Anticonvulsants - blood
Anticonvulsants - pharmacokinetics
antiepileptic drugs
Area Under Curve
Carbamazepine - adverse effects
Carbamazepine - analogs & derivatives
Carbamazepine - blood
Carbamazepine - pharmacokinetics
Child
Child, Preschool
Drug Therapy, Combination
Epilepsy - drug therapy
Epilepsy - metabolism
Female
Half-Life
Humans
inadequately controlled epilepsy
Male
Oxcarbazepine
pediatrics
pharmacokinetics
safety
tolerability
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Summary: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.
ISSN:0091-2700
1552-4604
DOI:10.1177/0091270004266617