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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:  06/21/2005
Trade Name:  Keppra
Generic Name or Proper Name (*):  levetiracetam
Indications Studied:  Adjunctive therapy in the treatment of partial onset seizures in patients with epilepsy
Label Changes Summary:  * Extended indication from adults to patients 4 years and older * Safety and effectiveness have not been established in patients less than 4 years of age * PK analysis showed that clearance increased with an increase in body weight * Approximately 22% increase of apparent total body clearance of levetiracetam when co-administered with enzyme-inducing Anti-Epileptic Drugs (AEDs). Dose adjustment not necessary * 37.6% of pediatric patients reported behavioral symptoms compared to 13.3% in adults * Somnolence occurred in 22.8% in pediatric patients compared to 14.8% in adults * Information on dose, PK parameters, AE profile and clinical studies
Product Labeling:  Labeling  Opens a new window
Sponsor:  UCB Pharma
Pediatric Exclusivity Granted Date:  06/03/2008
Therapeutic Category:  Anticonvulsant