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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 |
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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. |
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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 & 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</subject><ispartof>European journal of clinical pharmacology, 2008-12, Vol.64 (12), p.1197-1200</ispartof><rights>Springer-Verlag 2008</rights><rights>2009 INIST-CNRS</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c423t-4355414db50f67c3a32d81025ac1d273fd9ad6a5c5d18f30398966fef85ddd833</citedby><cites>FETCH-LOGICAL-c423t-4355414db50f67c3a32d81025ac1d273fd9ad6a5c5d18f30398966fef85ddd833</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27923,27924</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=20896583$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/18685840$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Dailly, E</creatorcontrib><creatorcontrib>Drouineau, M. 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. 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><subject>Antiemetics - administration & dosage</subject><subject>Antiemetics - blood</subject><subject>Antiemetics - pharmacokinetics</subject><subject>Antiemetics - therapeutic use</subject><subject>Babies</subject><subject>Biological and medical sciences</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Birth Weight</subject><subject>Domperidone</subject><subject>Domperidone - administration & dosage</subject><subject>Domperidone - blood</subject><subject>Domperidone - pharmacokinetics</subject><subject>Domperidone - therapeutic use</subject><subject>Drug therapy</subject><subject>Female</subject><subject>Gestational Age</subject><subject>Humans</subject><subject>Infant, Newborn</subject><subject>Infant, Premature - blood</subject><subject>Infant, Premature - metabolism</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Metabolic Clearance Rate</subject><subject>Models, Biological</subject><subject>Neonatal care</subject><subject>Pharmacokinetics and Disposition</subject><subject>Pharmacology</subject><subject>Pharmacology. Drug treatments</subject><subject>Pharmacology/Toxicology</subject><subject>Pilot Projects</subject><subject>Population pharmacokinetics</subject><subject>Predictive Value of Tests</subject><subject>Premature birth</subject><subject>Prescription drugs</subject><subject>Preterm neonates</subject><issn>0031-6970</issn><issn>1432-1041</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2008</creationdate><recordtype>article</recordtype><recordid>eNp9kUtLxTAQhYMoen38ADdaBJfVmTzadCOI-IILCuo6xDy0etvUpHfhvzfai-5cDFnMd84cTgjZRzhBgPo0AVAqS4A8gokS18gMOaMlAsd1MgNgWFZNDVtkO6U3ABQNsE2yhbKSQnKYkbP7MCwXemxDXwyvOnbahPe2d2NrUhF8YUM3uNja0LuizUh0o4td0bvQ69GlXbLh9SK5vdW7Q56uLh8vbsr53fXtxfm8NJyyseRMCI7cPgvwVW2YZtRKBCq0QUtr5m2jbaWFERalZ8Aa2VSVd14Ka61kbIccTb5DDB9Ll0b1FpaxzycVRc4lq5BmCCfIxJBSdF4Nse10_FQI6rswNRWmcmHquzCFWXOwMl4-d87-KVYNZeB4Behk9MJH3Zs2_XIUclLxk5BOXMqr_sXFv4T_XT-cRF4HpV9iNn56oIAs_1QloEb2BXl5iy4</recordid><startdate>20081201</startdate><enddate>20081201</enddate><creator>Dailly, E</creator><creator>Drouineau, M. 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C</creator><creator>Jolliet, P</creator><general>Berlin/Heidelberg : Springer-Verlag</general><general>Springer-Verlag</general><general>Springer</general><general>Springer Nature B.V</general><scope>FBQ</scope><scope>IQODW</scope><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7RV</scope><scope>7TK</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope></search><sort><creationdate>20081201</creationdate><title>Population pharmacokinetics of domperidone in preterm neonates</title><author>Dailly, E ; Drouineau, M. H ; Gournay, V ; Rozé, J. C ; Jolliet, P</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c423t-4355414db50f67c3a32d81025ac1d273fd9ad6a5c5d18f30398966fef85ddd833</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2008</creationdate><topic>Antiemetics - administration & dosage</topic><topic>Antiemetics - blood</topic><topic>Antiemetics - pharmacokinetics</topic><topic>Antiemetics - therapeutic use</topic><topic>Babies</topic><topic>Biological and medical sciences</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Birth Weight</topic><topic>Domperidone</topic><topic>Domperidone - administration & dosage</topic><topic>Domperidone - blood</topic><topic>Domperidone - pharmacokinetics</topic><topic>Domperidone - therapeutic use</topic><topic>Drug therapy</topic><topic>Female</topic><topic>Gestational Age</topic><topic>Humans</topic><topic>Infant, Newborn</topic><topic>Infant, Premature - blood</topic><topic>Infant, Premature - metabolism</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Metabolic Clearance Rate</topic><topic>Models, Biological</topic><topic>Neonatal care</topic><topic>Pharmacokinetics and Disposition</topic><topic>Pharmacology</topic><topic>Pharmacology. Drug treatments</topic><topic>Pharmacology/Toxicology</topic><topic>Pilot Projects</topic><topic>Population pharmacokinetics</topic><topic>Predictive Value of Tests</topic><topic>Premature birth</topic><topic>Prescription drugs</topic><topic>Preterm neonates</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Dailly, E</creatorcontrib><creatorcontrib>Drouineau, M. H</creatorcontrib><creatorcontrib>Gournay, V</creatorcontrib><creatorcontrib>Rozé, J. 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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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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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