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Negligible Amounts of ICS Budesonide Excreted in Breast Milk: Presented at ERS By Paula Moyer MUNICH, GERMANY -- September 8, 2006 -- Women with asthma who continue to take the inhaled corticosteroid (ICS) budesonide (Pulmicort) while breastfeeding excrete negligible amounts of the drug in their breast milk, according to a findings presented here at the 16th annual meeting of the European Respiratory Society (ERS). The findings should help physicians reassure women with asthma to continue their ICS therapy while breastfeeding, said principal investigator Anette Fält, BSc. research coordinator, AstraZeneca, Lund, Sweden, in a presentation on September 5th. She collaborated with Bengt Lindberg, MD, consultant, pediatrics department, University of Malmö, Malmö, Sweden. The investigators wanted to know the level of budesonide concentrations in the breast milk and plasma of women with asthma on maintenance treatment with budesonide. With this information, they estimated the systemic exposure to budesonide of breast-fed infants. For the study, breast milk and plasma samples were obtained from 8 women before they took their first morning dose of budesonide and up to 8 hours afterward. The women were taking either 200 or 400 mcg of budesonide twice daily. The investigators then calculated the pharmacokinetic parameters from the plasma and breast milk concentrations. The investigators also obtained a single blood sample from the infants 1 to 1.5 hours after the first feeding following the mother's treatment, which was expected to be the time of peak concentration. Infants' exposure was estimated based on the average concentration of budesonide in breast milk and a breast milk intake of 0.15 L/Kg daily. Concentrations of the drug in breast milk followed those in maternal plasma and were always lower than plasma levels. The average milk-to-plasma ratio based on the area-under-the-curve (AUC) was 0.46. Budesonide concentrations in plasma samples from 5 infants were below the limit of quantification (0.02 to 0.04 nmol/L). Based on the average breast milk concentration, the estimated daily infant dose was 0.3% of mother's daily dose. The estimated average plasma concentration in infants was about 600 times lower than the average maternal plasma concentration, the researchers said. Because of the route by which they were exposed, the investigators assumed 100% infant bioavailability, compared with 10% bioavailability in adults. The study was funded by AstraZeneca, which manufactures Pulmicort. [Presentation title: Negligible Exposure of Infants to Budesonide Via Breast Milk. Abstract P3855] E-mail this page to a friend or colleague! To print, use this version