Experience and pharmacokinetics of Levetiracetam in Korean neonates with neonatal seizures

• Published in: Clinical and experimental pediatrics Vol. 60; no. 2; pp. 50 - 54
• Main Authors: Shin, Jae Won, Jung, Yun Seob, Park, Kyungsoo, Lee, Soon Min, Eun, Ho Seon, Park, Min Soo, Park, Kook In, Namgung, Ran
• Format: Journal Article
• Language: English
• Published: Korea (South) Clinical and Experimental Pediatics / Korean Pediatric Society 01.02.2017; The Korean Pediatric Society; Korean Pediatric Society; 대한소아청소년과학회
• Subjects: Animal cognition; Apoptosis; Birth weight; Cognitive ability; Convulsions & seizures; Creatinine; Drug dosages; Electroencephalography; Gestational age; Laboratories; Levetiracetam; Neonatal seizure; Newborn babies; Original; Pharmacokinetics; Population pharmacokinetics; Safety; 소아과학; United States > US; Neonatal seizure; Population pharmacokinetics; Safety; Pharmacokinetics; Levetiracetam
• ISSN: 1738-1061; 2092-7258; 2713-4148
• DOI: 10.3345/kjp.2017.60.2.50

The aims of this study were to evaluate the safety and pharmacokinetics of levetiracetam (LEV) in neonates with seizures and to establish a population pharmacokinetics (PPK) model by using the software NONMEM. A retrospective analysis of 18 neonatal patients with seizures, who were treated with LEV, including 151 serum samples, was performed. The mean loading dose was 20 mg/kg, followed by a mean maintenance dose of 29 mg/kg/day. Seventeen neonates (94%) had seizure cessation within 1 week and 16 (84%) remained seizure-free at 30 days under the LEV therapy. The mean serum concentration of LEV was 8.7 µg/mL. Eight samples (5%) were found above the therapeutic range. No serious adverse effects were detected. In the PPK analysis for Korean neonates, the half-life was 9.6 hours; clearance, 0.357 L/hr; and volume of distribution, 4.947 L, showing differences from those in adults. LEV is a safe and effective option for the treatment of neonatal seizures with careful therapeutic drug monitoring.