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Phenobarbital pharmacokinetics in neonates.

W Pitlick, M Painter, C Pippenger

    Clinical Pharmacology and Therapeutics
    |March 1, 1978
    PubMed
    Summary

    Phenobarbital elimination slows in neonates over time, with clearance increasing as drug-metabolizing enzymes mature. This study tracked phenobarbital pharmacokinetics in infants with seizures.

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    Area of Science:

    • Neonatal Pharmacology
    • Clinical Pharmacokinetics
    • Pediatric Neurology

    Background:

    • Phenobarbital is a common anticonvulsant used in neonates.
    • Understanding its pharmacokinetic profile in this population is crucial for effective dosing.
    • Neonatal drug metabolism and elimination pathways differ significantly from adults.

    Purpose of the Study:

    • To investigate the pharmacokinetics of phenobarbital following intravenous administration in neonates with seizures.
    • To characterize the volume of distribution (Vd) and elimination half-life (t1/2) of phenobarbital in this patient group.
    • To develop a pharmacokinetic model to describe phenobarbital disposition and its changes over time.

    Main Methods:

    • Intravenous phenobarbital administration in 8 neonates (30-40 wk gestational age).
    • Plasma phenobarbital concentrations measured using enzyme-multiplied immunoassay (EMIT).
    • Pharmacokinetic parameters, including Vd and t1/2, were calculated; a pharmacokinetic model was developed.

    Main Results:

    • Phenobarbital Vd was 0.97 +/- 0.15 L/kg, independent of dose and gestational age.
    • Elimination half-life (t1/2) decreased from 115 hr at 1 week to 67 hr at 4 weeks of therapy.
    • A pharmacokinetic model with an exponentially increasing elimination rate term accurately predicted observed concentrations.

    Conclusions:

    • Phenobarbital elimination in neonates shows a significant decrease in half-life over the first four weeks of therapy.
    • Increased phenobarbital clearance is likely due to the maturation of drug-metabolizing enzymes in the neonatal liver.
    • The developed pharmacokinetic model provides adequate prediction of phenobarbital concentrations in neonates.

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