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Pharmacokinetics of Levetiracetam in Infants and Young Children with Epilepsy
Author(s) -
Glauser Tracy A.,
Mitchell Wendy G.,
Weinstock Arie,
Bebin Martina,
Chen Dion,
Coupez Rene,
Stockis Armel,
Lu Zhihong Sarah
Publication year - 2007
Publication title -
epilepsia
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.687
H-Index - 191
eISSN - 1528-1167
pISSN - 0013-9580
DOI - 10.1111/j.1528-1167.2007.01090.x
Subject(s) - levetiracetam , pharmacokinetics , medicine , dosing , epilepsy , pediatrics , population , regimen , adverse effect , piracetam , anesthesia , psychiatry , environmental health
Summary: Purpose : To assess the single‐dose pharmacokinetics of levetiracetam and its major metabolite ucb L057 in infants and young children with epilepsy. Methods : Eligible patients with a stable regimen of antiepileptic medications received a single oral dose of levetiracetam 20 mg/kg administered as a 10% oral solution followed by a 24‐hour pharmacokinetic evaluation. Results : Thirteen subjects (age 2.3–46.2 months) enrolled and received levetiracetam; 12 provided evaluable pharmacokinetic data. Levetiracetam was rapidly absorbed and reached peak plasma concentration (t max ) 1.4 ± 0.9 hours after dosing. The mean half‐life (t 1/2 ) of levetiracetam was 5.3 ± 1.3 hours, and the apparent clearance was 1.46 ± 0.42 mL/min/kg. Graphical differences were observed among three age subgroups (1 to <6 months, 6 to <24 months, and 24 to <48 months); however, statistical analysis was limited due to each subgroup's small sample size. No significant gender differences were detected. Treatment‐emergent adverse events were seen in three patients (23.1%) but were not considered to be related to levetiracetam. Conclusion s: The mean t 1/2 of levetiracetam was shorter and its apparent clearance was more rapid for infants and young children than that previously reported for adults. When determining dosage, age‐dependent drug clearance should be considered; these findings suggest that a larger dose of levetiracetam (corrected for body weight) needs to be considered for infants and young children with epilepsy than that given to adults with epilepsy. A single dose of levetiracetam was well tolerated in this study population.