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Exposure of infants to budesonide through breast milk of asthmatic mothers

Falt, Anette; Bengtsson, Thomas; Kennedy, Britt-Marie; Gyllenberg, Ann; Lindberg, Bengt LU ; Thorsson, Lars and Strandgarden, Kerstin (2007) In Journal of Allergy and Clinical Immunology 120(4). p.798-802
Abstract
Background: Maintenance treatment with inhaled corticosteroids is often required for asthmatic nursing women. Data on the transfer of inhaled corticosteroids from plasma to breast milk and the subsequent exposure of the breast-feeding infant has been unavailable. Objective: We sought to assess budesonide concentrations in milk and plasma of asthmatic nursing women receiving maintenance treatment with the Pulmicort Turbuhaler and estimate the exposure of their breast-fed infants. Methods: Milk and plasma samples were collected up to 8 hours after dosing from 8 mothers receiving budesonide maintenance treatment (200 or 400 mu g twice daily). Pharmacokinetic parameters were calculated from budesonide milk and plasma concentrations. Infant... (More)
Background: Maintenance treatment with inhaled corticosteroids is often required for asthmatic nursing women. Data on the transfer of inhaled corticosteroids from plasma to breast milk and the subsequent exposure of the breast-feeding infant has been unavailable. Objective: We sought to assess budesonide concentrations in milk and plasma of asthmatic nursing women receiving maintenance treatment with the Pulmicort Turbuhaler and estimate the exposure of their breast-fed infants. Methods: Milk and plasma samples were collected up to 8 hours after dosing from 8 mothers receiving budesonide maintenance treatment (200 or 400 mu g twice daily). Pharmacokinetic parameters were calculated from budesonide milk and plasma concentrations. Infant exposure was estimated based on average milk budesonide concentrations. A single blood sample was obtained from 5 infants close to expected infant maximum concentration. Results: Budesonide concentrations in milk reflected those in maternal plasma, supporting passive diffusion of budesonide between plasma and milk, and was always lower than that in plasma. The mean milk/plasma ratio was 0.46. The estimated daily infant dose was 0.3% of the daily maternal dose for both dose levels, and the average plasma concentration in infants was estimated to be 1/600th of the concentrations observed in maternal plasma, assuming complete infant oral bioavailability. Budesonide concentrations in infant plasma samples were all less than the limit of quantification. Conclusion: Maintenance treatment with inhaled budesonide (200 or 400 mu g twice daily) in asthmatic nursing women results in negligible systemic exposure to budesonide in breast-fed infants. Clinical implications: These data support continued use of inhaled budesonide during breast-feeding. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
breast milk, asthma, pulmicort, budesonide
in
Journal of Allergy and Clinical Immunology
volume
120
issue
4
pages
798 - 802
publisher
Elsevier
external identifiers
  • wos:000250157700012
  • scopus:35148869737
ISSN
1097-6825
DOI
10.1016/j.jaci.2007.07.023
language
English
LU publication?
yes
id
76cfd369-6e8c-4ccc-abf2-8ebdc1ca8b0e (old id 655219)
date added to LUP
2007-12-10 09:47:03
date last changed
2017-01-01 07:00:50
@article{76cfd369-6e8c-4ccc-abf2-8ebdc1ca8b0e,
  abstract     = {Background: Maintenance treatment with inhaled corticosteroids is often required for asthmatic nursing women. Data on the transfer of inhaled corticosteroids from plasma to breast milk and the subsequent exposure of the breast-feeding infant has been unavailable. Objective: We sought to assess budesonide concentrations in milk and plasma of asthmatic nursing women receiving maintenance treatment with the Pulmicort Turbuhaler and estimate the exposure of their breast-fed infants. Methods: Milk and plasma samples were collected up to 8 hours after dosing from 8 mothers receiving budesonide maintenance treatment (200 or 400 mu g twice daily). Pharmacokinetic parameters were calculated from budesonide milk and plasma concentrations. Infant exposure was estimated based on average milk budesonide concentrations. A single blood sample was obtained from 5 infants close to expected infant maximum concentration. Results: Budesonide concentrations in milk reflected those in maternal plasma, supporting passive diffusion of budesonide between plasma and milk, and was always lower than that in plasma. The mean milk/plasma ratio was 0.46. The estimated daily infant dose was 0.3% of the daily maternal dose for both dose levels, and the average plasma concentration in infants was estimated to be 1/600th of the concentrations observed in maternal plasma, assuming complete infant oral bioavailability. Budesonide concentrations in infant plasma samples were all less than the limit of quantification. Conclusion: Maintenance treatment with inhaled budesonide (200 or 400 mu g twice daily) in asthmatic nursing women results in negligible systemic exposure to budesonide in breast-fed infants. Clinical implications: These data support continued use of inhaled budesonide during breast-feeding.},
  author       = {Falt, Anette and Bengtsson, Thomas and Kennedy, Britt-Marie and Gyllenberg, Ann and Lindberg, Bengt and Thorsson, Lars and Strandgarden, Kerstin},
  issn         = {1097-6825},
  keyword      = {breast milk,asthma,pulmicort,budesonide},
  language     = {eng},
  number       = {4},
  pages        = {798--802},
  publisher    = {Elsevier},
  series       = {Journal of Allergy and Clinical Immunology},
  title        = {Exposure of infants to budesonide through breast milk of asthmatic mothers},
  url          = {http://dx.doi.org/10.1016/j.jaci.2007.07.023},
  volume       = {120},
  year         = {2007},
}