Korean J Pediatr.  2017 Feb;60(2):50-54. 10.3345/kjp.2017.60.2.50.

Experience and pharmacokinetics of Levetiracetam in Korean neonates with neonatal seizures

• Shin JW
• Jung YS
• Park K
• Lee SM
• Eun HS
• Park MS
• Park KI
• Namgung R

• KMID: 2371378
• DOI: http://doi.org/10.3345/kjp.2017.60.2.50

Abstract

PURPOSE
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.
METHODS
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.
RESULTS
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.
CONCLUSION
LEV is a safe and effective option for the treatment of neonatal seizures with careful therapeutic drug monitoring.

Keyword

Levetiracetam; Neonatal seizure; Population pharmacokinetics; Safety; Pharmacokinetics

MeSH Terms

Adult
Drug Monitoring
Half-Life
Humans
Infant, Newborn*
Pharmacokinetics*
Retrospective Studies
Seizures*