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Pharmacokinetic study of metopimazine by oral route in children.

Identifieur interne : 000089 ( PubMed/Corpus ); précédent : 000088; suivant : 000090

Pharmacokinetic study of metopimazine by oral route in children.

Auteurs : Eric Mallet ; Frederic Bounoure ; Mohamed Skiba ; Elodie Saussereau ; Jean-Pierre Goullé ; Mireille Castanet

Source :

Pharmacology research & perspectives ; 2015.

RBID : pubmed:26171218

Abstract

Metopimazine (MPZ) is an antiemetic considered as a currently used drug. In France, it has become the leading antiemetic mediator due to its good tolerance, however, its pharmacokinetics has never previously been studied in children. MPZ was administered by oral route to 8 children with a single dose of 0.33 mg/kg during an endocrine exploration using stimuli well known for its adverse emetic effects. We used biological remnants from sera following an hGH test in order to obtain the MPZ pharmacokinetics. Plasmatic concentrations of MPZ and the active acid metabolite AMPZ, were quantified by HPLC-MS/MS during a 270 min test period. MPZ is quickly absorbed with a median C max of 17.2 ng/mL at one hour and its half-life is 2.18 h. The plasmatic concentrations of AMPZ were higher than MPZ with a median C max of 76.3 ng/mL, a T max to 150 min and its concentration was approximately maintained at 50 ng/mL from 1 to 4 h. The plasmatic concentrations in children are similar to those observed in adults. No adverse effects, nausea or vomiting occurred during the trial. Therefore, these results confirm the MPZ dosage that should be used in children under 15 kg administered as 0.33 mg/kg up to 3 times a day.

DOI: 10.1002/prp2.130
PubMed: 26171218

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<author><name sortKey="Mallet, Eric" sort="Mallet, Eric" uniqKey="Mallet E" first="Eric" last="Mallet">Eric Mallet</name>
<affiliation><nlm:affiliation>CIC INSERM 204, Department of Pediatrics, Rouen University Hospital Charles Nicolle, 76031, Rouen, France.</nlm:affiliation>
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<author><name sortKey="Bounoure, Frederic" sort="Bounoure, Frederic" uniqKey="Bounoure F" first="Frederic" last="Bounoure">Frederic Bounoure</name>
<affiliation><nlm:affiliation>Pharmaceutics Laboratory (UMR CNRS 5007), Faculty of Medicine and Pharmacy, Rouen University 76183, Rouen, France.</nlm:affiliation>
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<author><name sortKey="Skiba, Mohamed" sort="Skiba, Mohamed" uniqKey="Skiba M" first="Mohamed" last="Skiba">Mohamed Skiba</name>
<affiliation><nlm:affiliation>Pharmaceutics Laboratory (UMR CNRS 5007), Faculty of Medicine and Pharmacy, Rouen University 76183, Rouen, France.</nlm:affiliation>
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<author><name sortKey="Saussereau, Elodie" sort="Saussereau, Elodie" uniqKey="Saussereau E" first="Elodie" last="Saussereau">Elodie Saussereau</name>
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<author><name sortKey="Goulle, Jean Pierre" sort="Goulle, Jean Pierre" uniqKey="Goulle J" first="Jean-Pierre" last="Goullé">Jean-Pierre Goullé</name>
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<author><name sortKey="Castanet, Mireille" sort="Castanet, Mireille" uniqKey="Castanet M" first="Mireille" last="Castanet">Mireille Castanet</name>
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<front><div type="abstract" xml:lang="en">Metopimazine (MPZ) is an antiemetic considered as a currently used drug. In France, it has become the leading antiemetic mediator due to its good tolerance, however, its pharmacokinetics has never previously been studied in children. MPZ was administered by oral route to 8 children with a single dose of 0.33 mg/kg during an endocrine exploration using stimuli well known for its adverse emetic effects. We used biological remnants from sera following an hGH test in order to obtain the MPZ pharmacokinetics. Plasmatic concentrations of MPZ and the active acid metabolite AMPZ, were quantified by HPLC-MS/MS during a 270 min test period. MPZ is quickly absorbed with a median C max of 17.2 ng/mL at one hour and its half-life is 2.18 h. The plasmatic concentrations of AMPZ were higher than MPZ with a median C max of 76.3 ng/mL, a T max to 150 min and its concentration was approximately maintained at 50 ng/mL from 1 to 4 h. The plasmatic concentrations in children are similar to those observed in adults. No adverse effects, nausea or vomiting occurred during the trial. Therefore, these results confirm the MPZ dosage that should be used in children under 15 kg administered as 0.33 mg/kg up to 3 times a day.</div>
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<Abstract><AbstractText>Metopimazine (MPZ) is an antiemetic considered as a currently used drug. In France, it has become the leading antiemetic mediator due to its good tolerance, however, its pharmacokinetics has never previously been studied in children. MPZ was administered by oral route to 8 children with a single dose of 0.33 mg/kg during an endocrine exploration using stimuli well known for its adverse emetic effects. We used biological remnants from sera following an hGH test in order to obtain the MPZ pharmacokinetics. Plasmatic concentrations of MPZ and the active acid metabolite AMPZ, were quantified by HPLC-MS/MS during a 270 min test period. MPZ is quickly absorbed with a median C max of 17.2 ng/mL at one hour and its half-life is 2.18 h. The plasmatic concentrations of AMPZ were higher than MPZ with a median C max of 76.3 ng/mL, a T max to 150 min and its concentration was approximately maintained at 50 ng/mL from 1 to 4 h. The plasmatic concentrations in children are similar to those observed in adults. No adverse effects, nausea or vomiting occurred during the trial. Therefore, these results confirm the MPZ dosage that should be used in children under 15 kg administered as 0.33 mg/kg up to 3 times a day.</AbstractText>
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Pharmacokinetic study of metopimazine by oral route in children.

Pharmacokinetic study of metopimazine by oral route in children.

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