Last update Jan. 16, 2023

Spironolactone

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

It is a steroid with a structure similar to that of the natural adrenocortical hormone aldosterone, being an antagonist of aldosterone receptors. It acts as a potassium-sparing diuretic, increasing the excretion of sodium and water. It is used for the treatment of hypertension, primary hyperaldosteronism, edema due to heart failure, liver cirrhosis, nephrotic syndrome, or associated with malignancy, and hypokalemia. It has antiandrogenic properties and is used to treat hirsutism, particularly polycystic ovarian syndrome. It is a prodrug that is metabolized to canrenone. Oral administration once a day

Excretion into breast milk is clinically non-significant (Phelps 1977) and without side-effects observed in breastfed infants of treated mothers. (de Jong 2022, Reisman 2018, Gutgesell 1990, Phelps 1977)

A medication which is used for treatment of infants even in the neonatal period.

It decreases slightly the secretion of Prolactin, however, instead other diuretic drugs, a suppressive effect on lactation has not been reported.

It can cause gynecomastia. (Trinchieri 2021, Deepinder 2012, Cuculi 2007)

American Academy of Pediatrics: medication usually compatible with breastfeeding.(AAP 2001). Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs: compatible with Breastfeeding. (WHO 2002)

Alternatives

We do not have alternatives for Spironolactone 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

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Other names

Spironolactone is also known as


Group

Spironolactone belongs to this group or family:

Tradenames

Main tradenames from several countries containing Spironolactone in its composition:

List of 50 tradenames

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 90 %
Molecular weight 417 daltons
Protein Binding 90 %
pKa 17.89 -
Tmax 1 - 2.6 hours
T½ 13 - 24 hours
M/P ratio 0.5 - 0.7 -
Theoretical Dose 0.016 mg/Kg/d
Relative Dose 1.9 %
Ped.Relat.Dose 0.5 - 1.6 %

References

  1. de Jong MFC, Riphagen IJ, Kootstra-Ros JE, Groenewout M. Potassium and Magnesium in Breast Milk of a Woman With Gitelman Syndrome. Kidney Int Rep. 2022 May 10;7(7):1720-1721. Abstract Full text (link to original source)
  2. Trinchieri A, Perletti G, Magri V, Stamatiou K, Trinchieri M, Montanari E. Drug-induced gynecomastia: A systematic review and meta-analysis of randomized clinical trials. Arch Ital Urol Androl. 2021 Dec 21;93(4):489-496. Abstract
  3. Anderson PO. Treating Hypertension During Breastfeeding. Breastfeed Med. 2018 Abstract
  4. Reisman T, Goldstein Z. Case Report: Induced Lactation in a Transgender Woman. Transgend Health. 2018 Jan 1;3(1):24-26. Abstract Full text (link to original source) Full text (in our servers)
  5. Kearney L, Wright P, Fhadil S, Thomas M. Postpartum Cardiomyopathy and Considerations for Breastfeeding. Card Fail Rev. 2018 Abstract Full text (link to original source) Full text (in our servers)
  6. Malachias MV, Figueiredo CE, Sass N, Antonello IC, Torloni MR, Bortolotto MRF L. 7th Brazilian Guideline of Arterial Hypertension: Chapter 9 - Arterial Hypertension in pregnancy Arq Bras Cardiol. 2016 Abstract Full text (link to original source) Full text (in our servers)
  7. Butler DC, Heller MM, Murase JE. Safety of dermatologic medications in pregnancy and lactation: Part II. Lactation. J Am Acad Dermatol. 2014 Mar;70(3):417.e1-10; quiz 427. Abstract
  8. Deepinder F, Braunstein GD. Drug-induced gynecomastia: an evidence-based review. Expert Opin Drug Saf. 2012 Sep;11(5):779-95. Abstract
  9. Nakhjavani M, Hamidi S, Esteghamati A, Abbasi M, Nosratian-Jahromi S, Pasalar P. Short term effects of spironolactone on blood lipid profile: a 3-month study on a cohort of young women with hirsutism. Br J Clin Pharmacol. 2009 Abstract
  10. Ghanem FA, Movahed A. Use of antihypertensive drugs during pregnancy and lactation. Cardiovasc Ther. 2008 Abstract Full text (link to original source) Full text (in our servers)
  11. Cuculi F, Suter A, Erne P. Spironolactone-induced gynecomastia. CMAJ. 2007 Feb 27;176(5):620. No abstract available. Abstract Full text (link to original source)
  12. 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)
  13. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001 Sep;108(3):776-89. Abstract Full text (link to original source) Full text (in our servers)
  14. Erenus M, Gürbüz O, Durmuşoğlu F, Demirçay Z, Pekin S. Comparison of the efficacy of spironolactone versus flutamide in the treatment of hirsutism. Fertil Steril. 1994 Abstract
  15. Cusan L, Dupont A, Gomez JL, Tremblay RR, Labrie F. Comparison of flutamide and spironolactone in the treatment of hirsutism: a randomized controlled trial. Fertil Steril. 1994 Abstract
  16. Vĕtr M, Sobek A. Low dose spironolactone in the treatment of female hyperandrogenemia and hirsutism. Acta Univ Palacki Olomuc Fac Med. 1993 Abstract
  17. Gutgesell M, Overholt E, Boyle R. Oral bretylium tosylate use during pregnancy and subsequent breastfeeding: a case report. Am J Perinatol. 1990 Apr;7(2):144-5. Abstract
  18. Phelps DL, Karim A. Spironolactone: relationship between concentrations of dethioacetylated metabolite in human serum and milk. J Pharm Sci. 1977 Abstract

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