Retrospective Population Pharmacokinetic Analysis of Levetiracetam in Children and??Adolescents with Epilepsy

Abstract

The most influential covariate of levetiracetam pharmacokinetics in children is bodyweight. A starting dose of levetiracetam 10 mg/kg twice daily ensures the same exposure in children as does 500 mg twice daily in adults.

Population Pharmacokinetic Modeling of Levetiracetam in Pediatric and Adult Patients With Epilepsy by Using Routinely Monitored Data

“…13,14 However, the exponential factors for creatinine clearance were 0.111 and 0.122, respectively, in the previous PPK analyses using data from clinical trials. 13,14 Because the eGFR values of present patients varied from 14.8 to 189 mL$min 21 $1.73 m 22 , the exponential factor for eGFR was estimated as 0.638, and CL/F was greatly dependent on the individual eGFR value compared with that previously reported 14 (Fig. 4).…”

“…[11][12][13][14] Three of the 4 analyses have been based on data from some clinical trials in the drug development processes, which had strict restrictions regarding patient inclusion and dosing criteria. 11,13,14 Therefore, levetiracetam pharmacokinetics in patients of different ages and varying renal function need to be clarified for dosage adjustment in actual clinical settings. To this end, in this study, a PPK model of levetiracetam was developed using routinely monitored serum concentration data of patients with epilepsy of different ages and with varying renal function.…”

Population pharmacokinetics modeling of levetiracetam in Chinese children with epilepsy

“…After parameterization according to previous studies [11,18] , the LEV concentrations were suited to using a one-compartment model and a first-order absorption process. The PPK modeling included the base model and final model.…”

“…The initial daily dose is 20 mg -1 ·kg -1 ·d -1 (10 mg/kg twice daily) and can go up to 60 mg -1 ·kg -1 ·d -1 . Even higher doses (>60 mg -1 ·kg -1 ·d -1 ) have also been reported [11] . Measuring the serum concentration (SC) of LEV can be useful in assessing compliance and managing patients in situations associated with pharmacokinetic (PK) alterations in pathological states such as renal impairment, as well as in specific age groups such as children and the elderly [12,13] .…”

Levetiracetam in der Zusatzbehandlung von Säuglingen und Kleinkindern mit fokalen Anfällen

“…Die Pharmakokinetik von LEV ist äußerst günstig und proportional zur verabreichten Dosis. Das Interaktionspotenzial ist bei Erwachsenen [15,33,37] und Kindern im Alter von mehr als 4 Jahren [13, 32,35,42] gering. Glauser et al [17] untersuchten die Pharmakokinetik von LEV bei Kindern im Alter von 2 bis 46 Monaten, und die Ergebnisse unterschieden sich nicht wesentlich von jenen bei älteren Kindern.…”