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- Title
Population pharmacokinetics of levetiracetam in neonates with seizures.
- Authors
Lima‐Rogel, V.; López‐López, E. J.; Medellín‐Garibay, S. E.; Gómez‐Ruiz, L. M.; Romero‐Méndez, C.; Milán‐Segovia, R. C.; Romano‐Moreno, S.
- Abstract
Summary: What is known and objective: This study developed a population pharmacokinetic (PK) model of levetiracetam (LEV) for treating neonatal seizures (NS) and determined the influence of clinically relevant covariates to explain the interindividual variability and residual error. Methods: Twenty newborns admitted to the Neonatal Intensive Care Unit at the Hospital Central “Dr. Ignacio Morones Prieto” were included. LEV doses were administered by intermittent infusion. Blood samples were drawn 3 times post‐infusion. Levetiracetam was quantified by a chromatographic technique. NONMEM software was used to determine the population PK model of LEV in neonates and the influence of clinical covariates on drug disposition. Results and discussion: The LEV PK in neonates is described by a one‐compartment open model with first‐order elimination. The influence of creatinine clearance (CRCL) and body weight (BW) on clearance (CL[L/h] = 0.47*CRCL), as well as the volume of the distribution (Vd[L] = 0.65*BW) of LEV, were confirmed, considering interindividual variabilities of 36% and 22%, respectively, and a residual error of 13%. What is new and Conclusion: Based on the PK of LEV in neonates and the influence of the final PK model, a priori dosing guidelines are proposed considering CRCL, BW and LEV plasma concentrations between 6 and 20 mg/L for NS treatment.
- Subjects
DRUG therapy for convulsions; HETEROCYCLIC compounds; NEONATAL intensive care; SPASMS; NEONATAL intensive care units; CHILDREN
- Publication
Journal of Clinical Pharmacy & Therapeutics, 2018, Vol 43, Issue 3, p422
- ISSN
0269-4727
- Publication type
Article
- DOI
10.1111/jcpt.12658