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Population pharmacokinetics of domperidone in preterm neonates

Purpose A population pharmacokinetic analysis was performed to define domperidone pharmacokinetic parameters in preterm neonates, as no pharmacokinetic data are available in this population. Methods An oral domperidone solution was administered (0.75 mg/kg per day) in 32 preterm neonates (64 samples...

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Published in:European journal of clinical pharmacology 2008-12, Vol.64 (12), p.1197-1200
Main Authors: Dailly, E, Drouineau, M. H, Gournay, V, Rozé, J. C, Jolliet, P
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description Purpose A population pharmacokinetic analysis was performed to define domperidone pharmacokinetic parameters in preterm neonates, as no pharmacokinetic data are available in this population. Methods An oral domperidone solution was administered (0.75 mg/kg per day) in 32 preterm neonates (64 samples). Domperidone plasma concentration was measured by high-performance liquid chromatography (HPLC) assay, and a one-compartment model with first-order absorption was fitted to the data using NONMEM version V level 1.1. Results The mean peak and trough plasma concentration values of domperidone were, respectively, 25.3 ± 20.5 ng/ml and 15.4 ± 11.4 ng/ml (mean ± standard deviation). The pharmacokinetic parameters (interindividual variability%) were clearance (Cl/F) = 0.92 L/h (51.6%), volume of distribution (Vd/F) = 0.405 L (68%), and absorption constant rate (Ka) = 0.0843 h⁻¹ (55.8%). The clearance is not lower than values reported in adults. No influence of covariates (postnatal age, prematurity, weight, gender) on domperidone pharmacokinetic parameters was found. Conclusion This pilot study designed with a limited sampling strategy showed that domperidone plasma concentrations were consistent with those reported in adults, suggesting that domperidone dosage regimen currently used in preterm neonates is suitable.
doi_str_mv 10.1007/s00228-008-0535-1
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H ; Gournay, V ; Rozé, J. C ; Jolliet, P</creator><creatorcontrib>Dailly, E ; Drouineau, M. H ; Gournay, V ; Rozé, J. C ; Jolliet, P</creatorcontrib><description>Purpose A population pharmacokinetic analysis was performed to define domperidone pharmacokinetic parameters in preterm neonates, as no pharmacokinetic data are available in this population. Methods An oral domperidone solution was administered (0.75 mg/kg per day) in 32 preterm neonates (64 samples). Domperidone plasma concentration was measured by high-performance liquid chromatography (HPLC) assay, and a one-compartment model with first-order absorption was fitted to the data using NONMEM version V level 1.1. Results The mean peak and trough plasma concentration values of domperidone were, respectively, 25.3 ± 20.5 ng/ml and 15.4 ± 11.4 ng/ml (mean ± standard deviation). The pharmacokinetic parameters (interindividual variability%) were clearance (Cl/F) = 0.92 L/h (51.6%), volume of distribution (Vd/F) = 0.405 L (68%), and absorption constant rate (Ka) = 0.0843 h⁻¹ (55.8%). The clearance is not lower than values reported in adults. No influence of covariates (postnatal age, prematurity, weight, gender) on domperidone pharmacokinetic parameters was found. Conclusion This pilot study designed with a limited sampling strategy showed that domperidone plasma concentrations were consistent with those reported in adults, suggesting that domperidone dosage regimen currently used in preterm neonates is suitable.</description><identifier>ISSN: 0031-6970</identifier><identifier>EISSN: 1432-1041</identifier><identifier>DOI: 10.1007/s00228-008-0535-1</identifier><identifier>PMID: 18685840</identifier><language>eng</language><publisher>Berlin/Heidelberg: Berlin/Heidelberg : Springer-Verlag</publisher><subject>Antiemetics - administration &amp; dosage ; Antiemetics - blood ; Antiemetics - pharmacokinetics ; Antiemetics - therapeutic use ; Babies ; Biological and medical sciences ; Biomedical and Life Sciences ; Biomedicine ; Birth Weight ; Domperidone ; Domperidone - administration &amp; dosage ; Domperidone - blood ; Domperidone - pharmacokinetics ; Domperidone - therapeutic use ; Drug therapy ; Female ; Gestational Age ; Humans ; Infant, Newborn ; Infant, Premature - blood ; Infant, Premature - metabolism ; Male ; Medical sciences ; Metabolic Clearance Rate ; Models, Biological ; Neonatal care ; Pharmacokinetics and Disposition ; Pharmacology ; Pharmacology. 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H</creatorcontrib><creatorcontrib>Gournay, V</creatorcontrib><creatorcontrib>Rozé, J. C</creatorcontrib><creatorcontrib>Jolliet, P</creatorcontrib><title>Population pharmacokinetics of domperidone in preterm neonates</title><title>European journal of clinical pharmacology</title><addtitle>Eur J Clin Pharmacol</addtitle><addtitle>Eur J Clin Pharmacol</addtitle><description>Purpose A population pharmacokinetic analysis was performed to define domperidone pharmacokinetic parameters in preterm neonates, as no pharmacokinetic data are available in this population. Methods An oral domperidone solution was administered (0.75 mg/kg per day) in 32 preterm neonates (64 samples). Domperidone plasma concentration was measured by high-performance liquid chromatography (HPLC) assay, and a one-compartment model with first-order absorption was fitted to the data using NONMEM version V level 1.1. Results The mean peak and trough plasma concentration values of domperidone were, respectively, 25.3 ± 20.5 ng/ml and 15.4 ± 11.4 ng/ml (mean ± standard deviation). The pharmacokinetic parameters (interindividual variability%) were clearance (Cl/F) = 0.92 L/h (51.6%), volume of distribution (Vd/F) = 0.405 L (68%), and absorption constant rate (Ka) = 0.0843 h⁻¹ (55.8%). The clearance is not lower than values reported in adults. No influence of covariates (postnatal age, prematurity, weight, gender) on domperidone pharmacokinetic parameters was found. 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H</au><au>Gournay, V</au><au>Rozé, J. C</au><au>Jolliet, P</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Population pharmacokinetics of domperidone in preterm neonates</atitle><jtitle>European journal of clinical pharmacology</jtitle><stitle>Eur J Clin Pharmacol</stitle><addtitle>Eur J Clin Pharmacol</addtitle><date>2008-12-01</date><risdate>2008</risdate><volume>64</volume><issue>12</issue><spage>1197</spage><epage>1200</epage><pages>1197-1200</pages><issn>0031-6970</issn><eissn>1432-1041</eissn><abstract>Purpose A population pharmacokinetic analysis was performed to define domperidone pharmacokinetic parameters in preterm neonates, as no pharmacokinetic data are available in this population. Methods An oral domperidone solution was administered (0.75 mg/kg per day) in 32 preterm neonates (64 samples). Domperidone plasma concentration was measured by high-performance liquid chromatography (HPLC) assay, and a one-compartment model with first-order absorption was fitted to the data using NONMEM version V level 1.1. Results The mean peak and trough plasma concentration values of domperidone were, respectively, 25.3 ± 20.5 ng/ml and 15.4 ± 11.4 ng/ml (mean ± standard deviation). The pharmacokinetic parameters (interindividual variability%) were clearance (Cl/F) = 0.92 L/h (51.6%), volume of distribution (Vd/F) = 0.405 L (68%), and absorption constant rate (Ka) = 0.0843 h⁻¹ (55.8%). The clearance is not lower than values reported in adults. No influence of covariates (postnatal age, prematurity, weight, gender) on domperidone pharmacokinetic parameters was found. Conclusion This pilot study designed with a limited sampling strategy showed that domperidone plasma concentrations were consistent with those reported in adults, suggesting that domperidone dosage regimen currently used in preterm neonates is suitable.</abstract><cop>Berlin/Heidelberg</cop><pub>Berlin/Heidelberg : Springer-Verlag</pub><pmid>18685840</pmid><doi>10.1007/s00228-008-0535-1</doi><tpages>4</tpages></addata></record>
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ispartof European journal of clinical pharmacology, 2008-12, Vol.64 (12), p.1197-1200
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subjects Antiemetics - administration & dosage
Antiemetics - blood
Antiemetics - pharmacokinetics
Antiemetics - therapeutic use
Babies
Biological and medical sciences
Biomedical and Life Sciences
Biomedicine
Birth Weight
Domperidone
Domperidone - administration & dosage
Domperidone - blood
Domperidone - pharmacokinetics
Domperidone - therapeutic use
Drug therapy
Female
Gestational Age
Humans
Infant, Newborn
Infant, Premature - blood
Infant, Premature - metabolism
Male
Medical sciences
Metabolic Clearance Rate
Models, Biological
Neonatal care
Pharmacokinetics and Disposition
Pharmacology
Pharmacology. Drug treatments
Pharmacology/Toxicology
Pilot Projects
Population pharmacokinetics
Predictive Value of Tests
Premature birth
Prescription drugs
Preterm neonates
title Population pharmacokinetics of domperidone in preterm neonates
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