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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
BPCA(B):
B
Sponsor:
UCB Pharma
Pediatric Exclusivity Granted Date:
06/03/2008
NNPS:
FALSE'
Therapeutic Category:
Anticonvulsant
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