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Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project

Introduction: Quantitative information on disposition of maternal medicines in human milk remains a major knowledge gap. This case report presents the clinical and pharmacokinetic data of a single mother-infant pair exposed to bosentan and sildenafil for the treatment of pulmonary arterial hypertens...

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Autores principales: Nauwelaerts, Nina, Ceulemans, Michael, Deferm, Neel, Eerdekens, An, Lammens, Bart, Armoudjian, Yeghig, Van Calsteren, Kristel, Allegaert, Karel, de Vries, Loes, Annaert, Pieter, Smits, Anne
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9240352/
https://www.ncbi.nlm.nih.gov/pubmed/35784689
http://dx.doi.org/10.3389/fphar.2022.881084
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author Nauwelaerts, Nina
Ceulemans, Michael
Deferm, Neel
Eerdekens, An
Lammens, Bart
Armoudjian, Yeghig
Van Calsteren, Kristel
Allegaert, Karel
de Vries, Loes
Annaert, Pieter
Smits, Anne
author_facet Nauwelaerts, Nina
Ceulemans, Michael
Deferm, Neel
Eerdekens, An
Lammens, Bart
Armoudjian, Yeghig
Van Calsteren, Kristel
Allegaert, Karel
de Vries, Loes
Annaert, Pieter
Smits, Anne
author_sort Nauwelaerts, Nina
collection PubMed
description Introduction: Quantitative information on disposition of maternal medicines in human milk remains a major knowledge gap. This case report presents the clinical and pharmacokinetic data of a single mother-infant pair exposed to bosentan and sildenafil for the treatment of pulmonary arterial hypertension (PAH) during lactation. Case presentation: A 43-year old mother was treated with sildenafil (20 mg, 3x/day) and bosentan (125 mg, 2x/day) for PAH. Her 21-months old infant received breastfeeding in combination with adequate complementary foods. Milk samples were collected over 24 h, at day 637 and 651 after delivery. The observed average steady-state concentrations of sildenafil (2.84 μg/L) and bosentan (49.0 μg/L) in human milk were low. The Daily Infant Dosage ingested by the nursing infant through human milk was 0.02 μg/kg/day for sildenafil and 0.29 μg/kg/day for bosentan at day 637, and 0.03 μg/kg/day and 0.60 μg/kg/day at day 651. The Relative Infant Dose calculated for an exclusively breastfed infant with an estimated milk intake of 150 ml/kg/day, was 0.06% for sildenafil and 0.24% for bosentan. General health outcome of the infant, reported by the mother, was uneventful until the sampling days. Conclusion: Low medicine concentrations were found in human milk expressed 21 months after delivery after maternal intake of 20 mg sildenafil three times daily and 125 mg bosentan twice daily. General health of the nursing infant until sampling was reported as optimal by the mother.
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spelling pubmed-92403522022-06-30 Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project Nauwelaerts, Nina Ceulemans, Michael Deferm, Neel Eerdekens, An Lammens, Bart Armoudjian, Yeghig Van Calsteren, Kristel Allegaert, Karel de Vries, Loes Annaert, Pieter Smits, Anne Front Pharmacol Pharmacology Introduction: Quantitative information on disposition of maternal medicines in human milk remains a major knowledge gap. This case report presents the clinical and pharmacokinetic data of a single mother-infant pair exposed to bosentan and sildenafil for the treatment of pulmonary arterial hypertension (PAH) during lactation. Case presentation: A 43-year old mother was treated with sildenafil (20 mg, 3x/day) and bosentan (125 mg, 2x/day) for PAH. Her 21-months old infant received breastfeeding in combination with adequate complementary foods. Milk samples were collected over 24 h, at day 637 and 651 after delivery. The observed average steady-state concentrations of sildenafil (2.84 μg/L) and bosentan (49.0 μg/L) in human milk were low. The Daily Infant Dosage ingested by the nursing infant through human milk was 0.02 μg/kg/day for sildenafil and 0.29 μg/kg/day for bosentan at day 637, and 0.03 μg/kg/day and 0.60 μg/kg/day at day 651. The Relative Infant Dose calculated for an exclusively breastfed infant with an estimated milk intake of 150 ml/kg/day, was 0.06% for sildenafil and 0.24% for bosentan. General health outcome of the infant, reported by the mother, was uneventful until the sampling days. Conclusion: Low medicine concentrations were found in human milk expressed 21 months after delivery after maternal intake of 20 mg sildenafil three times daily and 125 mg bosentan twice daily. General health of the nursing infant until sampling was reported as optimal by the mother. Frontiers Media S.A. 2022-06-15 /pmc/articles/PMC9240352/ /pubmed/35784689 http://dx.doi.org/10.3389/fphar.2022.881084 Text en Copyright © 2022 Nauwelaerts, Ceulemans, Deferm, Eerdekens, Lammens, Armoudjian, Van Calsteren, Allegaert, de Vries, Annaert and Smits. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Pharmacology
Nauwelaerts, Nina
Ceulemans, Michael
Deferm, Neel
Eerdekens, An
Lammens, Bart
Armoudjian, Yeghig
Van Calsteren, Kristel
Allegaert, Karel
de Vries, Loes
Annaert, Pieter
Smits, Anne
Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project
title Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project
title_full Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project
title_fullStr Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project
title_full_unstemmed Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project
title_short Case Report: Bosentan and Sildenafil Exposure in Human Milk - A Contribution From the ConcePTION Project
title_sort case report: bosentan and sildenafil exposure in human milk - a contribution from the conception project
topic Pharmacology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9240352/
https://www.ncbi.nlm.nih.gov/pubmed/35784689
http://dx.doi.org/10.3389/fphar.2022.881084
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