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

    Access Status
    Open access via publisher
    Authors
    Salman, S.
    Davis, T.
    Page-Sharp, Madhu
    Camara, B.
    Oluwalana, C.
    Bojang, A.
    D'Alessandro, U.
    Roca, A.
    Date
    2016
    Type
    Journal Article
    
    Metadata
    Show full item record
    Citation
    Salman, S. and Davis, T. and Page-Sharp, M. and Camara, B. and Oluwalana, C. and Bojang, A. and D'Alessandro, U. et al. 2016. Pharmacokinetics of transfer of azithromycin into the breast milk of African mothers. Antimicrobial Agents Chemotherapy. 60 (3): pp. 1592-1599.
    Source Title
    Antimicrob Agents Chemother
    DOI
    10.1128/AAC.02668-15
    School
    School of Pharmacy
    URI
    http://hdl.handle.net/20.500.11937/3851
    Collection
    • Curtin Research Publications
    Abstract

    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.

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