Last update: Feb. 19, 2017

Ketoconazole

Very Low Risk for breastfeeding


Safe. Compatible.
Not risky for breastfeeding or infant.

A high protein-binding capacity may explain its low excretion into breastmilk observed after oral administration.



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



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.



It would be wise to avoid applying creams, gels and other topical products containing paraffin (mineral oil) on the nipple so that the infant could not ingest it (Noti 2003, Concin 2008).



American Academy of Pediatrics: medication usually compatible with breastfeeding.

Alternatives

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

Suggestions made at e-lactancia are done by APILAM´s pediatricians and pharmacists, and are based on updated scientific publications.
It is not intended to replace the relationship you have with your doctor but to compound it.

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.

Pharmacokinetics

Variable Value Unit
Bioavailability 75 %
Molecular weight 531 daltons
Protein Binding 99 %
Tmax 2 hours
T1/2 2 - 8 hours
Theoretical Dose 0,01 - 0, 03 mg/Kg/d
Relative Dose 0,3 (0,15 - 0,9) %

References

  1. AEMPS. Ketoconazol óvulos vaginales. Ficha técnica. 2015 Full text (in our servers)
  2. 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
  3. 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
  4. Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006 Abstract
  5. 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
  6. 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)
  7. 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
  8. Moretti ME, Ito S, Koren G. Disposition of maternal ketoconazole in breast milk. Am J Obstet Gynecol. 1995 Abstract
  9. 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
  10. 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)
  11. 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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