Population Pharmacokinetics of Amoxicillin in Term Neonates Undergoing Moderate Hypothermia

Y. A. Bijleveld; Raa Mathôt; J. H. van der Lee; F. Groenendaal; P. H. Dijk; A. van Heijst; Shp Simons; K. P. Dijkman; Hlm van Straaten; M. Rijken; I. A. Zonnenberg; F. Cools; A. Zecic; Dhgm Nuytemans; A. H. van Kaam; T. R. de Haan

doi:https://doi.org/10.1002/cpt.748

Population Pharmacokinetics of Amoxicillin in Term Neonates Undergoing Moderate Hypothermia

Y. A. Bijleveld, Raa Mathôt, J. H. van der Lee, F. Groenendaal, P. H. Dijk, A. van Heijst, Shp Simons, K. P. Dijkman, Hlm van Straaten, M. Rijken, I. A. Zonnenberg, F. Cools, A. Zecic, Dhgm Nuytemans, A. H. van Kaam, T. R. de Haan

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Abstract

The pharmacokinetics (PK) of amoxicillin in asphyxiated newborns undergoing moderate hypothermia were quantified using prospective data (N = 125). The population PK was described by a 2-compartment model with a priori birthweight (BW) based allometric scaling. Significant correlations were observed between clearance (Cl) and postnatal age (PNA), gestational age (GA), body temperature (TEMP), and urine output (UO). For a typical patient with GA 40 weeks, BW 3,000 g, 2 days PNA (i.e., TEMP 33.5°C), and normal UO, Cl was 0.26 L/h (interindividual variability (IIV) 41.9%) and volume of distribution of the central compartment was 0.34 L/kg (IIV of 114.6%). For this patient, Cl increased to 0.41 L/h at PNA 5 days and TEMP 37.0°C. The respective contributions of both covariates were 23% and 27%. Based on Monte Carlo simulations we recommend 50 and 75 mg/kg/24h amoxicillin in three doses for patients with GA 36-37 and 38-42 weeks, respectively

Original language	English
Pages (from-to)	458-467
Number of pages	10
Journal	Clinical Pharmacology and Therapeutics
Volume	103
Issue number	3
Early online date	2017
DOIs	https://doi.org/10.1002/cpt.748
Publication status	Published - 1 Mar 2018

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Bijleveld, Y. A., Mathôt, R., van der Lee, J. H., Groenendaal, F., Dijk, P. H., van Heijst, A., Simons, S., Dijkman, K. P., van Straaten, H., Rijken, M., Zonnenberg, I. A., Cools, F., Zecic, A., Nuytemans, D., van Kaam, A. H., & de Haan, T. R. (2018). Population Pharmacokinetics of Amoxicillin in Term Neonates Undergoing Moderate Hypothermia. Clinical Pharmacology and Therapeutics, 103(3), 458-467. https://doi.org/10.1002/cpt.748

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title = "Population Pharmacokinetics of Amoxicillin in Term Neonates Undergoing Moderate Hypothermia",

abstract = "The pharmacokinetics (PK) of amoxicillin in asphyxiated newborns undergoing moderate hypothermia were quantified using prospective data (N = 125). The population PK was described by a 2-compartment model with a priori birthweight (BW) based allometric scaling. Significant correlations were observed between clearance (Cl) and postnatal age (PNA), gestational age (GA), body temperature (TEMP), and urine output (UO). For a typical patient with GA 40 weeks, BW 3,000 g, 2 days PNA (i.e., TEMP 33.5°C), and normal UO, Cl was 0.26 L/h (interindividual variability (IIV) 41.9%) and volume of distribution of the central compartment was 0.34 L/kg (IIV of 114.6%). For this patient, Cl increased to 0.41 L/h at PNA 5 days and TEMP 37.0°C. The respective contributions of both covariates were 23% and 27%. Based on Monte Carlo simulations we recommend 50 and 75 mg/kg/24h amoxicillin in three doses for patients with GA 36-37 and 38-42 weeks, respectively",

author = "Bijleveld, {Y. A.} and Raa Math{\^o}t and {van der Lee}, {J. H.} and F. Groenendaal and Dijk, {P. H.} and {van Heijst}, A. and Shp Simons and Dijkman, {K. P.} and {van Straaten}, Hlm and M. Rijken and Zonnenberg, {I. A.} and F. Cools and A. Zecic and Dhgm Nuytemans and {van Kaam}, {A. H.} and {de Haan}, {T. R.}",

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Bijleveld, YA, Mathôt, R, van der Lee, JH, Groenendaal, F, Dijk, PH, van Heijst, A, Simons, S, Dijkman, KP, van Straaten, H, Rijken, M, Zonnenberg, IA, Cools, F, Zecic, A, Nuytemans, D , van Kaam, AH & de Haan, TR 2018, 'Population Pharmacokinetics of Amoxicillin in Term Neonates Undergoing Moderate Hypothermia', Clinical Pharmacology and Therapeutics, vol. 103, no. 3, pp. 458-467. https://doi.org/10.1002/cpt.748

TY - JOUR

T1 - Population Pharmacokinetics of Amoxicillin in Term Neonates Undergoing Moderate Hypothermia

AU - Bijleveld, Y. A.

AU - Mathôt, Raa

AU - van der Lee, J. H.

AU - Groenendaal, F.

AU - Dijk, P. H.

AU - van Heijst, A.

AU - Simons, Shp

AU - Dijkman, K. P.

AU - van Straaten, Hlm

AU - Rijken, M.

AU - Zonnenberg, I. A.

AU - Cools, F.

AU - Zecic, A.

AU - Nuytemans, Dhgm

AU - van Kaam, A. H.

AU - de Haan, T. R.

PY - 2018/3/1

Y1 - 2018/3/1

N2 - The pharmacokinetics (PK) of amoxicillin in asphyxiated newborns undergoing moderate hypothermia were quantified using prospective data (N = 125). The population PK was described by a 2-compartment model with a priori birthweight (BW) based allometric scaling. Significant correlations were observed between clearance (Cl) and postnatal age (PNA), gestational age (GA), body temperature (TEMP), and urine output (UO). For a typical patient with GA 40 weeks, BW 3,000 g, 2 days PNA (i.e., TEMP 33.5°C), and normal UO, Cl was 0.26 L/h (interindividual variability (IIV) 41.9%) and volume of distribution of the central compartment was 0.34 L/kg (IIV of 114.6%). For this patient, Cl increased to 0.41 L/h at PNA 5 days and TEMP 37.0°C. The respective contributions of both covariates were 23% and 27%. Based on Monte Carlo simulations we recommend 50 and 75 mg/kg/24h amoxicillin in three doses for patients with GA 36-37 and 38-42 weeks, respectively

AB - The pharmacokinetics (PK) of amoxicillin in asphyxiated newborns undergoing moderate hypothermia were quantified using prospective data (N = 125). The population PK was described by a 2-compartment model with a priori birthweight (BW) based allometric scaling. Significant correlations were observed between clearance (Cl) and postnatal age (PNA), gestational age (GA), body temperature (TEMP), and urine output (UO). For a typical patient with GA 40 weeks, BW 3,000 g, 2 days PNA (i.e., TEMP 33.5°C), and normal UO, Cl was 0.26 L/h (interindividual variability (IIV) 41.9%) and volume of distribution of the central compartment was 0.34 L/kg (IIV of 114.6%). For this patient, Cl increased to 0.41 L/h at PNA 5 days and TEMP 37.0°C. The respective contributions of both covariates were 23% and 27%. Based on Monte Carlo simulations we recommend 50 and 75 mg/kg/24h amoxicillin in three doses for patients with GA 36-37 and 38-42 weeks, respectively

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M3 - Article

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SP - 458

EP - 467

JO - Clinical Pharmacology and Therapeutics

JF - Clinical Pharmacology and Therapeutics

IS - 3

ER -

Population Pharmacokinetics of Amoxicillin in Term Neonates Undergoing Moderate Hypothermia

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