Pharmacokinetic Study of Levetiracetam in Children

Purpose: The pharmacokinetics of the novel antiepileptic drug (AED) levetiracetam and its major metabolite, ucb L057, were studied in children with partial seizures in a multicenter, open‐label, single‐dose study. Methods: Twenty‐four children (15 boys, nine girls), 6 to 12 years old, received a sin...

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Vydané v:	Epilepsia (Copenhagen) Ročník 42; číslo 12; s. 1574 - 1579
Hlavní autori:	Pellock, John M., Glauser, Tracy A., Bebin, E. Martina, Fountain, Nathan B., Ritter, Frank J., Coupez, René M., Shields, W. Donald
Médium:	Journal Article
Jazyk:	English
Vydavateľské údaje:	Boston, MA, USA Blackwell Science Inc 01.12.2001 Blackwell
Predmet:	Adult Age Factors Anticonvulsants - pharmacokinetics Anticonvulsants - therapeutic use Anticonvulsants. Antiepileptics. Antiparkinson agents Biological and medical sciences Child Creatine - metabolism Epilepsy Epilepsy - drug therapy Epilepsy - metabolism Female Humans Keppra Levetiracetam Male Medical sciences Metabolic Clearance Rate Middle Aged Neuropharmacology Pediatric Pharmacokinetics Pharmacology. Drug treatments Piracetam - analogs & derivatives Piracetam - pharmacokinetics Piracetam - therapeutic use ucb L057 Human Nervous system diseases Metabolite Epilepsy Multicenter study Anticonvulsant Clearance Metabolism Cerebral disorder Chemotherapy Treatment Partial Central nervous system disease Pharmacokinetics Child Levetiracetam
ISSN:	0013-9580, 1528-1167
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Shrnutí:	Purpose: The pharmacokinetics of the novel antiepileptic drug (AED) levetiracetam and its major metabolite, ucb L057, were studied in children with partial seizures in a multicenter, open‐label, single‐dose study. Methods: Twenty‐four children (15 boys, nine girls), 6 to 12 years old, received a single dose of levetiracetam (20 mg/kg) as an adjunct to their stable regimen of a single concomitant AED, followed by a 24‐h pharmacokinetic evaluation. Results: In children, the half‐lives of levetiracetam and its metabolite ucb L057 were 6.0 ± 1.1 and 8.1 ± 2.7 hours, respectively. The Cmax and area under the curve (AUC) of levetiracetam equated for a 1‐mg/kg dose were lower in children (Cmax, norm = 1.33 ± 0.35 μg/ml; AUCnorm = 12.4 ± 3.5 μg/h/ml) than in adults (Cmax, norm = 1.38 ± 0.05 μg/ml; AUCnorm = 11.48 ± 0.63 μg/h/ml), whereas the renal clearance was higher. The apparent body clearance (1.43 ± 0.36 ml/min/kg) was ∼30–40% higher in children than in adults. Levetiracetam was generally well tolerated. Conclusions: On the basis of these data, a daily maintenance dose equivalent to 130–140% of the usual daily adult maintenance dosage (1,000–3,000 mg/day) in two divided doses, on a weight‐normalized level (mg/kg/day) is initially recommended. Clinical efficacy trials in children are ongoing with dosages of 20 to 60 mg/kg/day.
Bibliografia:	ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-Feature-1 content type line 23
ISSN:	0013-9580 1528-1167
DOI:	10.1046/j.1528-1157.2001.41300.x