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- Title
Prospective Open-Label, Single-Arm, Multicenter, Safety, Tolerability, and Pharmacokinetic Studies of Intravenous Levetiracetam in Children With Epilepsy.
- Authors
Weinstock, Arie; Ruiz, Matilde; Gerard, Danielle; Toublanc, Nathalie; Stockis, Armel; Farooq, Osman; Dilley, Deanne; Karmon, Yuval; Elgie, Mary Jo; Schiemann-Delgado, Jimmy
- Abstract
Levetiracetam given via intravenous administration has been shown to be an effective alternative in adults with epilepsy when oral administration is not feasible. This study was a prospective single-arm, multicenter study to assess tolerability, safety, and pharmacokinetics of intravenous levetiracetam in children with epilepsy. Children with epilepsy ages 1 month to 16 years requiring intravenous levetiracetam were enrolled. Assessments included vital signs, electrocardiogram, hematology, chemistry, plasma concentrations of antiepileptic medications, weight, physical/neurological examinations, and pharmacokinetics. A total of 52 patients were enrolled. Mild to moderate treatment-emergent adverse events occurred in 63%, the most frequent being pyrexia and dry mouth. Most other treatment-emergent adverse events were considered unrelated to intravenous levetiracetam administration. Therefore, intravenous levetiracetam in the acute setting was overall well tolerated in children 1 month to 16 years.
- Subjects
CHILDHOOD epilepsy; PEOPLE with epilepsy; ELECTROCARDIOGRAPHY; PARENTERAL feeding; TREATMENT of fever; PHARMACOKINETICS
- Publication
Journal of Child Neurology, 2013, Vol 28, Issue 11, p1423
- ISSN
0883-0738
- Publication type
Article
- DOI
10.1177/0883073813480241