Last update July 22, 2022

Miconazole

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

It is a broad-spectrum azole antifungal. It is used to treat fungal infections (candidiasis, dermatophytosis, pityriasis versicolor) of the vagina, oropharynx, intestine, and skin. Topical application.

Since the last update we have not found published data on its excretion in breastmilk.

Excretion into breast milk is highly unlikely due to an almost nil systemic absorption through the skin, vaginal mucosa and even the intestine, with non-significant plasma levels (< 1 mcg/ mL) observed. (Chen 2010, Eichenfield 2007, Cardot 2004, Mactal 2001, Dhondt 1992, Daneshmend 1986)

Miconazole has not been found to be more effective than pure lanolin for treatment of sore or cracked nipples. (Dennis 2012)

In case of use on the nipple, let it be done after the feed and wipe it out any excess of cream before the next feed. A 17-day-old female infant with thrush was almost asphyxiated by miconazole oral gel that had been applied to the nipples of her mother's breasts. The infant recovered after her mother had removed the gel from her mouth. (de Vries 2004)

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)

Several medical societies and expert authors consider the use of this medication to be safe or very probably safe during breastfeeding (Hale, Briggs 2015, Schaefer 2015, Amir 2011, Chen 2010, Leachman 2006) . List of Essential Medicines by WHO 2002: compatible with breastfeeding. (WHO 2002)

Alternatives

  • Clotrimazole ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Fluconazole ( Safe. Compatible. Minimal risk for breastfeeding and infant.)
  • Nystatin ( Safe. Compatible. Minimal risk for breastfeeding and infant.)

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

Miconazole in other languages or writings:

Tradenames

Main tradenames from several countries containing Miconazole in its composition:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 25 %
Molecular weight 416 daltons
Protein Binding 91 %
Tmax 4 hours
24 hours

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. 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
  3. Schaefer C, Peters P, Miller RK. Drugs During Pregnancy and Lactation. Treatment options and risk assessment. Elsevier, Third Edition. 2015
  4. Dennis CL, Schottle N, Hodnett E, McQueen K. An all-purpose nipple ointment versus lanolin in treating painful damaged nipples in breastfeeding women: a randomized controlled trial. Breastfeed Med. 2012 Dec;7(6):473-9. Abstract
  5. 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)
  6. Chen LH, Zeind C, Mackell S, LaPointe T, Mutsch M, Wilson ME. Breastfeeding travelers: precautions and recommendations. J Travel Med. 2010 Jan-Feb;17(1):32-47. Abstract Full text (link to original source) Full text (in our servers)
  7. 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
  8. Eichenfield LF, Bogen ML. Absorption and efficacy of miconazole nitrate 0.25% ointment in infants with diaper dermatitis. J Drugs Dermatol. 2007 Abstract
  9. Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006 Abstract
  10. de Vries TW, Wewerinke ME, de Langen JJ. [Near asphyxiation of a neonate due to miconazole oral gel]. Ned Tijdschr Geneeskd. 2004 Abstract
  11. Cardot JM, Chaumont C, Dubray C, Costantini D, Aiache JM. Comparison of the pharmacokinetics of miconazole after administration via a bioadhesive slow release tablet and an oral gel to healthy male and female subjects. Br J Clin Pharmacol. 2004 Abstract
  12. 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
  13. 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)
  14. Mactal-Haaf C, Hoffman M, Kuchta A. Use of anti-infective agents during lactation, Part 3: Antivirals, antifungals, and urinary antiseptics. J Hum Lact. 2001 Abstract
  15. Dhondt F, Ninane J, De Beule K, Dhondt A, Cauwenbergh G. Oral candidosis: treatment with absorbable and non-absorbable antifungal agents in children. Mycoses. 1992 Abstract

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