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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:  10/30/2014
 
Trade Name:  Keppra
 
Generic Name or Proper Name (*):  levetiracetam
 
Indications Studied:  Partial onset seizures in patients 1 month and older; Primary generalized tonic-clonic seizures in patients 6 years and older; Myoclonic seizures in patients with juvenile myoclonic epilepsy 12 years and older
 
Label Changes Summary:  *Safety and efficacy established for adjunctive treatment of Partial onset seizures (POS, 1 mo to 16 years), Primary generalized tonic clonic seizures (PGTC, 6- 16 years), Myoclonic seizures (12-16 years) *Efficacy for adjunctive treatment of POS established in two multicenter, randomized double-blind, placebo-controlled trials: one trial enrolled 198 patients aged 4-16 years; the other enrolled 116 patients aged 1 month to less than 4 years with partial seizures, uncontrolled by standard epileptic drugs. *Efficacy for adjunctive treatment of PGTC established in one multicenter, randomized double-blind, placebo-controlled trial in 164 patients aged 6 years and older with idiopathic generalized epilepsy experiencing primary generalized tonic-clonic seizures. *Efficacy for adjunctive treatment of myoclonic seizures established in one multicenter, randomized double-blind, placebo-controlled trial in 120 patients aged 12 years and older with juvenile myoclonic epilepsy experiencing myoclonic seizures. *PK studies in pediatric patients established weight-based dosing. *In a 3-month, randomized, double-blind, placebo-controlled study of levetiracetim in 98 patients, aged 4-16 years with partial seizures that were inadequately controlled on prior therapy, there were noeurocognitive or behavioral differences between levetiracetim and placebo. *Common adverse reactions in pediatric patients include fatigue, aggression, nasal congestion, decreased appetite, irritability, decrease in WBC and neutrophil counts, increase in diastolic blood pressure *Age-specific toxicity was studied in juvenile rates and dogs at doses of up to 1800 mg/kg/day and did not indicate a potential for age-specific toxicity
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  UCB
 
Therapeutic Category:  Anticonvulsant
 
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