Is Fludrocortisone Acetate compatible with breastfeeding? Do we have alternatives for Fludrocortisone Acetate?

Fludrocortisone Acetate

October 20, 2016 (Low Risk)

Steroidal drug with glucocorticoid action and high activity as mineralocorticoid.
Systemic administration: oral route. Topical administration: creams as dermatologic compounds and eye drops for ophthalmologic use.
Indicated as replacement therapy in Adrenal Insufficiency (Addison’s Disease) and "salt-losing" Congenital Adrenal Hyperplasia.

At latest update relevant published data were not found on excretion into breast milk.
Other corticosteroids are know to be excreted into breastmilk in small amounts.
Since the goal of treatment is to keep the mother within normal plasma hormone ranges, by monitoring adequately through analytical controls to make sure the mother is receiving a correct dose, it would neither interfere with breastfeeding nor would be harmful to the infant. Take as lowest effective dose as possible with follow-up the infant for hypo-adrenal signs.

The small dose used along with a poor passage to plasma of most ophthalmologic and topical dermatologic preparations makes it very unlikely that a significant excretion into breastmilk would occur.
Do not apply on the breast to prevent ingestion by the infant; otherwise, do it just after a meal and clean the nipple thoroughly with water before the next feed. Mineral-corticoid poisoning occurred in an infant after long-term application of a corticoid cream on the nipple (De Stefano 1983).

Alternatives

We do not have alternatives for Fludrocortisone Acetate.

Very Low Risk

Compatible. Not risky for breastfeeding or infant.

Low Risk

Moderately safe. Mild risk possible. Follow up recommended. Read the Comment.

High Risk

Poorly safe. Evaluate carefully. Use a safer alternative. Read the Comment.

Very High Risk

Not recommended. Cessation of breastfeeding or alternative.

Synonyms

  • 9α-Fluorohydrocortisone 21-Acetate

Writings

  • Флудрокортизона Ацетат (Cyrillic)
  • フルドロコルチゾン酢酸エステル (Japanese)
  • C23H31FO6 (Molecular formula)

References

  1. Polito A, Hamitouche N, Ribot M, Polito A, Laviolle B, Bellissant E, Annane D, Alvarez JC. Pharmacokinetics of oral fludrocortisone in septic shock. Br J Clin Pharmacol. 2016Abstract
  2. AEMPS. Fludrocortisona. Ficha técnica. 2016 Full text (in our servers)
  3. ASPEN. Fludrocortisone. Drug Summary. 2015 Full text (in our servers)
  4. Merck Fludrocortison. Drogen Zusammenfassung. 2014 Full text (in our servers)
  5. WHO / UNICEF. BREASTFEEDING AND MATERNAL MEDICATION Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. Department of Child and Adolescent Health and Development (WHO/UNICEF) 2002 Full text (link to original source) Full text (in our servers)
  6. De Stefano P, Bongo IG, Borgna-Pignatti C, Severi F. Factitious hypertension with mineralocorticoid excess in an infant. Helv Paediatr Acta. 1983Abstract