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Maturation of Oxycodone Pharmacokinetics in Neonates and Infants: a Population Pharmacokinetic Model of Three Clinical Trials
Leiden Univ, Div Pharmacol, Leiden, Netherlands..
Kuopio Univ Hosp, Dept Anesthesia & Operat Serv, POB 100, FI-70029 Kuopio, Finland.;Univ Eastern Finland, Sch Med, Kuopio, Finland..
Univ Eastern Finland, Sch Pharm, Kuopio, Finland..
Univ Helsinki, Dept Anesthesiol Intens Care & Pain Med, Helsinki, Finland.;Helsinki Univ Hosp, Helsinki, Finland..
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2017 (English)In: Pharmaceutical research, ISSN 0724-8741, E-ISSN 1573-904X, Vol. 34, no 5, 1125-1133 p.Article in journal (Refereed) Published
Abstract [en]

Purpose The aim of the current population pharmacokinetic study was to quantify oxycodone pharmacokinetics in children ranging from preterm neonates to children up to 7 years of age. Methods Data on intravenous or intramuscular oxycodone administration were obtained from three previously published studies (n = 119). The median [range] postmenstrual age of the subjects was 299 days [170 days-7.8 years]. A population pharmacokinetic model was built using 781 measurements of oxycodone plasma concentration. The model was used to simulate repeated intravenous oxycodone administration in four representative infants covering the age range from an extremely preterm neonate to 1-year old infant. Results The rapid maturation of oxycodone clearance was best described with combined allometric scaling and maturation function. Central and peripheral volumes of distribution were nonlinearly related to bodyweight. The simulations on repeated intravenous administration in virtual patients indicated that oxycodone plasma concentration can be kept between 10 and 50 ng/ml with a high probability when the maintenance dose is calculated using the typical clearance and the dose interval is 4 h. Conclustions Oxycodone clearance matures rapidly after birth, and between-subject variability is pronounced in neonates. The pharmacokinetic model developed may be used to evaluate different multiple dosing regimens, but the safety of repeated doses should be ensured.

Place, publisher, year, edition, pages
SPRINGER/PLENUM PUBLISHERS , 2017. Vol. 34, no 5, 1125-1133 p.
Keyword [en]
analgesic, opioid. infant, extremely premature, oxycodone, pain, pharmacokinetics
National Category
Medicinal Chemistry
Identifiers
URN: urn:nbn:se:uu:diva-321794DOI: 10.1007/s11095-017-2122-6ISI: 000399164800019PubMedID: 28205004OAI: oai:DiVA.org:uu-321794DiVA: diva2:1094789
Available from: 2017-05-11 Created: 2017-05-11 Last updated: 2017-05-11Bibliographically approved

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