Budesonide

Drug Levels and Effects:




Summary of Use during Lactation:


The amounts of inhaled budesonide excreted into breastmilk are minute and infant exposure is negligible. Reviewers and an expert panel consider inhaled corticosteroids acceptable to use during breastfeeding.[1][2][3] When taken by mouth, budesonide is only about 9% bioavailable; bioavailability in the infant is likely to be similarly low for any budesonide that enters the breastmilk.


Drug Levels:


Maternal Levels.

Eight women with asthma were using inhaled budesonide 200 mcg (n = 4) or 400 mcg twice daily (n = 4) by Pulmicort Turbihaler. Peak milk levels of budesonide of 168 ng/L and 335 ng/L occurred at 32 and 43 minutes after inhalation with the 200 mcg and 400 mcg doses, respectively. Average infant doses were estimated to be 6.8 and 14.2 ng/kg daily for the 200 mcg and 400 mcg dosages. A fully breastfed infant would receive a maximum of 0.3% of the weight-adjusted maternal dosage, assuming 100% oral bioavailability from breastmilk.[4]

Infant Levels.

Four infants whose mothers were taking budesonide 200 mcg (n = 2) or 400 mcg (n = 2) twice daily by Pulmicort Turbihaler. The infants had serum samples taken 1.5 hours (range 0.7 to 2 hours) after the first breastfeeding after drug administration and 2.3 hours (range 2.1 to 2.6 hours) after maternal drug inhalation. All had undetectable (<8.6 to 17.2 ng/L) serum budesonide concentrations.[4]


Effects in Breastfed Infants:


None reported with any corticosteroid.


Possible Effects on Lactation:


Relevant published information was not found as of the revision date.


Alternate Drugs to Consider:


Beclomethasone


References:


1. Greenberger PA, Patterson R. The management of asthma during pregnancy and lactation. Clin Rev Allergy. 1987;5:317-24. PMID:3319123
2. Ellsworth A. Pharmacotherapy of asthma while breastfeeding. J Hum Lact. 1994;10:39-41. PMID:7619245
3. National Heart, Lung, and Blood Institute, National Asthma Education and Prevention Program Asthma and Pregnancy Working Group. NAEPP expert panel report. Managing asthma during pregnancy: recommendations for pharmacologic treatment-2004 update. 2004;1-57. http://www.nhlbi.nih.gov/health/prof/lung/asthma/astpreg.htm
4. Falt A, Bengtsson T, Kennedy BM et al. Exposure of infants to budesonide through breast milk of asthmatic mothers. J Allergy Clin Immunol. 2007;120:798-802. PMID:17825891



Substance Identification:




Substance Name:

Budesonide

CAS Registry Number:

51333-22-3

Drug Class:


  • Anti-Asthmatic Agents

  • Corticosteroids, Inhaled

  • Anti-allergic Agents

  • Corticosteroids, Systemic


  • Administrative Information:




    LactMed Record Number:


    35


    Last Revision Date:


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