Pharmacokinetics of transfer of azithromycin into the breast milk of African mothers

Azithromycin (AZI) is used for its antibiotic and antimalarial properties in pregnancy. Reported estimates of AZI breast milk transfer, based on concentrations in single samples from small numbers of women, have suggested that infant intake is safe. To better characterize infant intake and the assoc...

Full description

Bibliographic Details
Main Authors: Salman, S., Davis, T., Page-Sharp, Madhu, Camara, B., Oluwalana, C., Bojang, A., D'Alessandro, U., Roca, A.
Format: Journal Article
Published: 2016
Online Access:68396
http://hdl.handle.net/20.500.11937/3851
_version_ 1848744344467537920
author Salman, S.
Davis, T.
Page-Sharp, Madhu
Camara, B.
Oluwalana, C.
Bojang, A.
D'Alessandro, U.
Roca, A.
author_facet Salman, S.
Davis, T.
Page-Sharp, Madhu
Camara, B.
Oluwalana, C.
Bojang, A.
D'Alessandro, U.
Roca, A.
author_sort Salman, S.
building Curtin Institutional Repository
collection Online Access
description Azithromycin (AZI) is used for its antibiotic and antimalarial properties in pregnancy. Reported estimates of AZI breast milk transfer, based on concentrations in single samples from small numbers of women, have suggested that infant intake is safe. To better characterize infant intake and the associated potential benefits and risks, AZI was measured by liquid chromatography-mass spectrometry in four breast milk samples taken over 28 days postpartum from each of 20 Gambian women given 2 g AZI during labor. A population pharmacokinetic model utilizing published parameters for AZI disposition in pregnancy, the present breast milk concentrations, and increasing/decreasing sigmoid Emax functions, adequately described temporal changes in the milk:plasma ratio. The median estimated absolute and relative cumulative infant doses were 4.5 (95% prediction interval 0.6-7.0) mg/kg and 15.7 (95% prediction interval 2.0-27.8) % of maternal dose, respectively, the latter exceeding the recommended 10% safety limit. Although some infants with bacterial infections may benefit from AZI in breast milk, there is a risk of hypertrophic pyloric stenosis with a worst-case number needed to harm of 60 based on the present and available epidemiologic data.
first_indexed 2025-11-14T05:59:58Z
format Journal Article
id curtin-20.500.11937-3851
institution Curtin University Malaysia
institution_category Local University
last_indexed 2025-11-14T05:59:58Z
publishDate 2016
recordtype eprints
repository_type Digital Repository
spelling curtin-20.500.11937-38512023-02-22T06:24:15Z Pharmacokinetics of transfer of azithromycin into the breast milk of African mothers Salman, S. Davis, T. Page-Sharp, Madhu Camara, B. Oluwalana, C. Bojang, A. D'Alessandro, U. Roca, A. Azithromycin (AZI) is used for its antibiotic and antimalarial properties in pregnancy. Reported estimates of AZI breast milk transfer, based on concentrations in single samples from small numbers of women, have suggested that infant intake is safe. To better characterize infant intake and the associated potential benefits and risks, AZI was measured by liquid chromatography-mass spectrometry in four breast milk samples taken over 28 days postpartum from each of 20 Gambian women given 2 g AZI during labor. A population pharmacokinetic model utilizing published parameters for AZI disposition in pregnancy, the present breast milk concentrations, and increasing/decreasing sigmoid Emax functions, adequately described temporal changes in the milk:plasma ratio. The median estimated absolute and relative cumulative infant doses were 4.5 (95% prediction interval 0.6-7.0) mg/kg and 15.7 (95% prediction interval 2.0-27.8) % of maternal dose, respectively, the latter exceeding the recommended 10% safety limit. Although some infants with bacterial infections may benefit from AZI in breast milk, there is a risk of hypertrophic pyloric stenosis with a worst-case number needed to harm of 60 based on the present and available epidemiologic data. 2016 Journal Article http://hdl.handle.net/20.500.11937/3851 10.1128/AAC.02668-15 68396 unknown
spellingShingle Salman, S.
Davis, T.
Page-Sharp, Madhu
Camara, B.
Oluwalana, C.
Bojang, A.
D'Alessandro, U.
Roca, A.
Pharmacokinetics of transfer of azithromycin into the breast milk of African mothers
title Pharmacokinetics of transfer of azithromycin into the breast milk of African mothers
title_full Pharmacokinetics of transfer of azithromycin into the breast milk of African mothers
title_fullStr Pharmacokinetics of transfer of azithromycin into the breast milk of African mothers
title_full_unstemmed Pharmacokinetics of transfer of azithromycin into the breast milk of African mothers
title_short Pharmacokinetics of transfer of azithromycin into the breast milk of African mothers
title_sort pharmacokinetics of transfer of azithromycin into the breast milk of african mothers
url 68396
http://hdl.handle.net/20.500.11937/3851