title: Oxcarbazepine pharmacokinetics and tolerability in children with inadequately controlled epilepsy.
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 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.
authors.affiliation: Hôpital St. Vincent de Paul, 74, Avenue Denfert-Rochereau, 75 674 Paris Cedex 14, France.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Rey
authors.forename: Christine
authors.initials: C
authors.lastname: Bulteau
authors.forename: Jacques
authors.initials: J
authors.lastname: Motte
authors.forename: Agnes
authors.initials: A
authors.lastname: Tran
authors.forename: Yvonne
authors.initials: Y
authors.lastname: Sturm
authors.forename: Joseph
authors.initials: J
authors.lastname: D'Souza
authors.forename: Sabri
authors.initials: S
authors.lastname: Markabi
authors.forename: Gérard
authors.initials: G
authors.lastname: Pons
authors.forename: Olivier
authors.initials: O
authors.lastname: Dulac
mesh_terms: D000927:Anticonvulsants / Q000009:adverse effects* / Q000097:blood / Q000493:pharmacokinetics*; D019540:Area Under Curve; D002220:Carbamazepine / Q000009:adverse effects* / Q000031:analogs & derivatives* / Q000097:blood / Q000493:pharmacokinetics*; D002648:Child; D002675:Child, Preschool; D004359:Drug Therapy, Combination; D004827:Epilepsy / Q000188:drug therapy / Q000378:metabolism*; D005260:Female; D006207:Half-Life; D006801:Humans; D008297:Male; D000078330:Oxcarbazepine
chemical_list: D000927:Anticonvulsants; D002220:Carbamazepine; D000078330:Oxcarbazepine