Last update July 21, 2022

Budesonide

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

It is a potent glucocorticoid used inhaled for asthma, nasally for rhinitis and polyps, orally for inflammatory bowel disease, and applied topically on various skin disorders.

It is excreted in breast milk in clinically insignificant amounts. (Fält 2007)

Plasma levels in these infants were undetectable. (Fält 2007)

Its low oral bioavailability protects the infant from intestinal absorption.

Furthermore, long-term administration of inhaled budesonide to young children with severe asthma does not affect pituitary-adrenal function or final growth. (Berger 2005, Irani 2002, Volovitz 1993)

Several medical societies and expert authors consider topical, systemic or inhaled steroid medication to be compatible with breastfeeding. (Hale, LactMed, Middleton 2020, McConnell 2016, Damas 2015, Briggs 2015, Schaefer 2015, Schulze 2014, Amir 2011, Mottet 2007, Powrie 2006, National Asthma 2004, Ellsworth 1994)

 

TOPICAL USE:

Whenever a treatment for nipple eczema or dermatitis is required, the lowest potency steroid compound should be used. It should be applied right after the feed to make sure it has disappeared before the next nursing. Otherwise, wipe cream out with a clean gauze. Do not continuously use for longer than a week. Reportedly, a case of mineral-steroid toxicity has occurred due to continuous use of cream on the nipple. (De Stefano 1983)

Creams, gels or similar products that contain paraffin or mineral oil should not be used on the nipple to avoid absorption by the infant.(Concin 2008, Noti 2003)

Alternatives

We do not have alternatives for Budesonide since it is relatively safe.

Suggestions made at e-lactancia are done by APILAM team of health professionals, and are based on updated scientific publications. It is not intended to replace the relationship you have with your doctor but to compound it. The pharmaceutical industry contraindicates breastfeeding, mistakenly and without scientific reasons, in most of the drug data sheets.

Jose Maria Paricio, Founder & President of APILAM/e-Lactancia

Your contribution is essential for this service to continue to exist. We need the generosity of people like you who believe in the benefits of breastfeeding.

Thank you for helping to protect and promote breastfeeding.

José María Paricio, founder of e-lactancia.

Other names

Budesonide in other languages or writings:

Tradenames

Main tradenames from several countries containing Budesonide in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. oral: 9-21; inhal: 6 %
Molecular weight 431 daltons
Protein Binding 85 - 90 %
VD 2.2 - 3.9 l/Kg
Tmax 0.2 - 08 hours
2 - 3.6 hours
M/P ratio 0.5 -
Theoretical Dose 0.00001 mg/Kg/d
Relative Dose 0.3 %

References

  1. Hale TW. Medications & Mothers' Milk. 1991- . Springer Publishing Company. Available from https://www.halesmeds.com Consulted on March 17, 2022 Full text (link to original source)
  2. LactMed. Drugs and Lactation Database (LactMed). Internet. Bethesda (MD): National Library of Medicine (US); 2006-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK501922/ 2006 - Consulted on March 15, 2022 Full text (link to original source)
  3. Middleton PG, Gade EJ, Aguilera C, MacKillop L, Button BM, Coleman C, Johnson B, Albrechtsen C, Edenborough F, Rigau D, Gibson PG, Backer V. ERS/TSANZ Task Force Statement on the management of reproduction and pregnancy in women with airways diseases. Eur Respir J. 2020 Feb 6;55(2). pii: 1901208. Abstract Full text (link to original source) Full text (in our servers)
  4. McConnell RA, Mahadevan U. Pregnancy and the Patient with Inflammatory Bowel Disease: Fertility, Treatment, Delivery, and Complications. Gastroenterol Clin North Am. 2016 Abstract
  5. Damas OM, Deshpande AR, Avalos DJ, Abreu MT. Treating Inflammatory Bowel Disease in Pregnancy: The Issues We Face Today. J Crohns Colitis. 2015 Oct;9(10):928-36. Abstract Full text (link to original source) Full text (in our servers)
  6. Briggs GG, Freeman RK, Towers CV, Forinash AB. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. Wolters Kluwer Health. Tenth edition (acces on line) 2015
  7. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, Third Edition. 2015
  8. Schulze H, Esters P, Dignass A. Review article: the management of Crohn's disease and ulcerative colitis during pregnancy and lactation. Aliment Pharmacol Ther. 2014 Nov;40(9):991-1008. Abstract Full text (link to original source) Full text (in our servers)
  9. Amir LH, Pirotta MV, Raval M. Breastfeeding--evidence based guidelines for the use of medicines. Aust Fam Physician. 2011 Sep;40(9):684-90. Review. Abstract Full text (link to original source) Full text (in our servers)
  10. Mottet C, Vader JP, Felley C, Froehlich F, Gonvers JJ, Juillerat P, Stockbrügger R, Angelucci E, Seibold F, Michetti P, Pittet V; EPACT II Study Group. Appropriate management of special situations in Crohn's disease (upper gastro-intestinal; extra-intestinal manifestations; drug safety during pregnancy and breastfeeding): Results of a multidisciplinary international expert panel-EPACT II. J Crohns Colitis. 2009 Abstract Full text (link to original source) Full text (in our servers)
  11. Concin N, Hofstetter G, Plattner B, Tomovski C, Fiselier K, Gerritzen K, Fessler S, Windbichler G, Zeimet A, Ulmer H, Siegl H, Rieger K, Concin H, Grob K. Mineral oil paraffins in human body fat and milk. Food Chem Toxicol. 2008 Abstract
  12. Fält A, Bengtsson T, Kennedy BM, Gyllenberg A, Lindberg B, Thorsson L, Stråndgarden K. Exposure of infants to budesonide through breast milk of asthmatic mothers. J Allergy Clin Immunol. 2007 Abstract Full text (link to original source) Full text (in our servers)
  13. Mottet C, Juillerat P, Pittet V, Gonvers JJ, Froehlich F, Vader JP, Michetti P, Felley C. Pregnancy and breastfeeding in patients with Crohn's disease. Digestion. 2007 Abstract
  14. Powrie RO, Larson L, Miller M. Managing asthma in expectant mothers. Treat Respir Med. 2006;5(1):1-10. Abstract
  15. Berger WE. Budesonide inhalation suspension for the treatment of asthma in infants and children. Drugs. 2005;65(14):1973-89. Review. Abstract
  16. National Asthma Education and Prevention Program Asthma and Pregnancy Working Group. Managing asthma during pregnancy: recommendations for pharmacologic treatment-2004 update. 2004;1-57. None 2004 Full text (link to original source) Full text (in our servers)
  17. Noti A, Grob K, Biedermann M, Deiss U, Brüschweiler BJ. Exposure of babies to C15-C45 mineral paraffins from human milk and breast salves. Regul Toxicol Pharmacol. 2003 Abstract
  18. Irani AM, Cruz-Rivera M, Fitzpatrick S, Hoag J, Smith JA. Effects of budesonide inhalation suspension on hypothalamic-pituitary-adrenal-axis function in infants and young children with persistent asthma. Ann Allergy Asthma Immunol. 2002 Mar;88(3):306-12. Abstract
  19. Ellsworth A. Pharmacotherapy of asthma while breastfeeding. J Hum Lact. 1994 Abstract
  20. Volovitz B, Amir J, Malik H, Kauschansky A, Varsano I. Growth and pituitary-adrenal function in children with severe asthma treated with inhaled budesonide. N Engl J Med. 1993 Dec 2;329(23):1703-8. Abstract Full text (link to original source)
  21. De Stefano P, Bongo IG, Borgna-Pignatti C, Severi F. Factitious hypertension with mineralocorticoid excess in an infant. Helv Paediatr Acta. 1983 Abstract

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