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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
 
BPCA(B):  B
 
Sponsor:  UCB Pharma
 
Pediatric Exclusivity Granted Date:  06/03/2008
 
NNPS:  FALSE'
 
Therapeutic Category:  Anticonvulsant
 
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