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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  10/28/2005
Trade Name:  Trileptal
Generic Name or Proper Name (*):  oxcarbazepine
Indications Studied:  Use as adjunctive therapy in children aged 2 years and above with epilepsy
Label Changes Summary:  * Extended adjunctive therapy age range from 4 years down to 2 years * No evidence drug was effective as adjunctive therapy in patients < 2 years * In clinical studies as adjunctive therapy, apparent clearance (L/hr/kg) decreased when age increased such that children 2 to <4 years of age may require up to twice the dose per body weight compared to adults; and children 4 to d12 years of age may require a 50% higher dose per body weight compared to adults * Approximately 11% of pediatric patients < 4 years discontinued treatment because of adverse events including convulsions, status epilepticus and ataxia * Information on dose, PK parameters, AE profile and clinical studies
Product Labeling:  Labeling  Opens a new window
Sponsor:  Novartis
Pediatric Exclusivity Granted Date:  03/02/2005
Therapeutic Category:  Neurology