Is Ketoconazole compatible with breastfeeding? Do we have alternatives for Ketoconazole?

Ketoconazole

February 19, 2017 (Very Low Risk)

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.

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

  • ケトコナゾール
  • كيتوكونازول
  • Κετοκοναζόλη
  • Кетоконазол
  • 酮康唑

Drug trade names

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. 2014Abstract
  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. 2008Abstract
  4. Leachman SA, Reed BR. The use of dermatologic drugs in pregnancy and lactation. Dermatol Clin. 2006Abstract
  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. 2003Abstract
  6. Mactal-Haaf C, Hoffman M, Kuchta A. Use of anti-infective agents during lactation, Part 3: Antivirals, antifungals, and urinary antiseptics. J Hum Lact. 2001Abstract
  7. AAP - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001Abstract Full text (link to original source) Full text (in our servers)
  8. Moretti ME, Ito S, Koren G. Disposition of maternal ketoconazole in breast milk. Am J Obstet Gynecol. 1995Abstract
  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. 1992Abstract
  10. Huang YC, Colaizzi JL, Bierman RH, Woestenborghs R, Heykants J. Pharmacokinetics and dose proportionality of ketoconazole in normal volunteers. Antimicrob Agents Chemother. 1986Abstract 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. 1984Abstract Full text (link to original source) Full text (in our servers)