Prospective Open-Label, Single-Arm, Multicenter, Safety, Tolerability, and Pharmacokinetic Studies of Intravenous Levetiracetam in Children With Epilepsy

被引：21

作者：

Weinstock, Arie ^{[1
]}

Ruiz, Matilde ^{[2
]}

Gerard, Danielle ^{[3
]}

Toublanc, Nathalie ^{[4
]}

Stockis, Armel ^{[4
]}

Farooq, Osman ^{[1
]}

Dilley, Deanne ^{[5
]}

Karmon, Yuval ^{[1
]}

Elgie, Mary Jo ^{[1
]}

Schiemann-Delgado, Jimmy ^{[5
]}

机构：

[1] SUNY Buffalo, Buffalo, NY 14260 USA

[2] Inst Nacl Pediat, Coyoacan, Mexico

[3] UCB Pharma, Brussels, Belgium

[4] UCB Pharma, Braine Lalleud, Belgium

[5] UCB Pharma, Raleigh, NC USA

来源：

JOURNAL OF CHILD NEUROLOGY | 2013年 / 28卷 / 11期

关键词：

intravenous; levetiracetam; pharmacokinetics; epilepsy; PARTIAL-ONSET SEIZURES; ADJUNCTIVE LEVETIRACETAM; STATUS EPILEPTICUS; INFUSION; THERAPY; VALPROATE; EFFICACY; PLACEBO; TABLETS;

D O I：

10.1177/0883073813480241

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

100204 [神经病学];

摘要：

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 1month 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 1month to 16 years.

引用

页码：1423 / 1429

页数：7

共 17 条

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Intravenous levetiracetam in critically ill children with status epilepticus or acute repetitive seizures [J].