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Single-dose ceftriaxone kinetics in the newborn.

U B Schaad, W L Hayton, K Stoeckel

    Clinical Pharmacology and Therapeutics
    |May 1, 1985
    PubMed
    Summary

    Newborn infants have longer ceftriaxone elimination half-lives and reduced clearance compared to adults, necessitating adjusted dosing. Female infants show altered ceftriaxone pharmacokinetics, impacting drug distribution and clearance.

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    Area of Science:

    • Pharmacology
    • Neonatal Medicine
    • Drug Metabolism

    Background:

    • Ceftriaxone is a widely used antibiotic in neonatal care.
    • Understanding ceftriaxone pharmacokinetics in neonates is crucial for safe and effective treatment.
    • Infant physiology differs significantly from adult physiology, impacting drug handling.

    Purpose of the Study:

    • To characterize the pharmacokinetic profile of ceftriaxone in sick newborn infants.
    • To compare ceftriaxone kinetics in neonates with established adult data.
    • To provide evidence-based dosing recommendations for ceftriaxone in the neonatal population.

    Main Methods:

    • Single intravenous infusion of ceftriaxone (50 mg/kg) in 20 sick infants (1-8 days old).
    • Plasma protein binding determined by equilibrium dialysis.
    • Kinetic parameters for free and total ceftriaxone calculated.
    • Comparison with historical adult data.

    Main Results:

    • Infants exhibited a longer elimination half-life (19 vs. 8.4 hours) and reduced systemic clearance (4.48 vs. 8.51 ml/min/m2) compared to adults.
    • Apparent steady-state volume of distribution was similar between infants and adults.
    • Reduced renal and nonrenal clearance in infants was partially offset by increased free fraction due to lower plasma protein binding.
    • Mean urinary excretion of unchanged ceftriaxone was higher in neonates (70%) than adults (46%).
    • Female infants had lower free ceftriaxone fractions and altered drug clearance and distribution compared to males.

    Conclusions:

    • Ceftriaxone dosing of 50-100 mg/day is recommended for neonates in the first week of life.
    • Dosage adjustments may be necessary for neonates with impaired renal function.
    • Sex-based differences in ceftriaxone pharmacokinetics warrant consideration in neonatal dosing.

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