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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
 
BPCA(B):  B
 
Sponsor:  Novartis
 
Pediatric Exclusivity Granted Date:  03/02/2005
 
NNPS:  FALSE
 
Therapeutic Category:  Neurology        
 
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