Last update Sept. 1, 2022

Кетоконазол

Very Low Risk

Safe. Compatible. Minimal risk for breastfeeding and infant.

Ketoconazole is a broad-spectrum antifungal imidazole used to treat seborrheic dermatitis, fungal skin infections, and vaginal candidiasis. In addition, it is a potent inhibitor of cortisol synthesis and is used orally for the treatment of endogenous Cushing's syndrome. Topical (dermatological, vaginal) or oral administration once daily.

A high protein-binding capacity explain its low excretion into breastmilk observed after oral administration, and no problems were observed in the infant. (Moretti 1995)

Low levels that would reach the infant’s gut through breastmilk would barely be absorbed due to the alkaline environment that hinders the absorption. (Butler 2014)

Because it is topically used on creams or vaginal ovules, it would have a low or nil absorption in mother’s plasma (Ene 1984, AEMPS 2015), hence, the amount excreted in milk is expected to be even lower than that following a systemic administration.

Do not apply on the breasts to prevent the infant from ingesting it; if necessary, apply after one feeding and clean well with water before the next.

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)

Expert authors consider the use of this medication to be probably safe during breastfeeding (LacMed, Hale, Briggs 2015, Butler 2014, Mactal 2001). American Academy of Pediatrics: medication usually compatible with breastfeeding.(AAP 2001)

Alternatives

  • Clotrimazole ( 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

Кетоконазол is Ketoconazole in Cyrillic.

Is written in other languages:

Pharmacokinetics

Variable Value Unit
Oral Bioavail. 76 %
Molecular weight 531 daltons
Protein Binding 99 %
VD 0.36 l/Kg
pKa 2.9 -
Tmax 1 - 4 hours
2 - 8 hours
Theoretical Dose 0.01 - 0. 03 mg/Kg/d
Relative Dose 0.3 (0.15 - 1.4) %

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. AEMPS. Ketoconazol óvulos vaginales. Ficha técnica. 2015 Full text (in our servers)
  4. 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
  5. 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
  6. 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
  7. Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006 Abstract
  8. 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
  9. 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)
  10. 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
  11. Moretti ME, Ito S, Koren G. Disposition of maternal ketoconazole in breast milk. Am J Obstet Gynecol. 1995 Abstract
  12. 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
  13. Huang YC, Colaizzi JL, Bierman RH, Woestenborghs R, Heykants J. Pharmacokinetics and dose proportionality of ketoconazole in normal volunteers. Antimicrob Agents Chemother. 1986 Abstract Full text (link to original source) Full text (in our servers)
  14. Ene MD, Williamson PJ, Daneshmend TK, Blatchford NR. Systemic absorption of ketoconazole from vaginal pessaries. Br J Clin Pharmacol. 1984 Abstract Full text (link to original source) Full text (in our servers)

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