Question

I am a breastfeeding mother and i want to know if it is safe to use Ketoconazolum? Is Ketoconazolum safe for nursing mother and child? Does Ketoconazolum extracts into breast milk? Does Ketoconazolum has any long term or short term side effects on infants? Can Ketoconazolum influence milk supply or can Ketoconazolum decrease milk supply in lactating mothers?

Ketoconazolum lactation summary

Ketoconazolum is safe in breastfeeding
  • DrLact safety Score for Ketoconazolum is 1 out of 8 which is considered Safe as per our analyses.
  • A safety Score of 1 indicates that usage of Ketoconazolum is mostly safe during lactation for breastfed baby.
  • Our study of different scientific research also indicates that Ketoconazolum does not cause any serious side effects in breastfeeding mothers.
  • Most of scientific studies and research papers declaring usage of Ketoconazolum safe in breastfeeding are based on normal dosage and may not hold true for higher dosage.
  • Score calculated using the DrLact safety Version 1.2 model, this score ranges from 0 to 8 and measures overall safety of drug in lactation. Scores are primarily calculated using publicly available case studies, research papers, other scientific journals and publically available data.

Answer by Dr. Ru: About Ketoconazolum usage in lactation

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.

Answer by DrLact: About Ketoconazolum usage in lactation

Because there is little published experience with Ketoconazolum during breastfeeding and its potential liver enzyme inhibition and liver toxicity, other agents may be preferred. However, if oral Ketoconazolum is required by the mother, it may not be a reason to discontinue breastfeeding.[1] Taking the dose just before the infant's longest sleep period or avoiding breastfeeding from 2 to 5 hours after the dose might decrease the infant's exposure to Ketoconazolum. Use of Ketoconazolum shampoo or topical use on the skin by the mother poses little or no risk to the breastfed infant.[2][3] However, topical use on the breast or nipples should be avoided in nursing mothers because of possible oral ingestion by the infant and the availability of safer alternatives. Only water-miscible cream or gel products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.[4]

Ketoconazolum Side Effects in Breastfeeding

A mother taking Ketoconazolum 200 mg orally for 10 days noticed no adverse effects in her breastfed 1-month-old infant.[1]
Disclaimer: Information presented in this database is not meant as a substitute for professional judgment. You should consult your healthcare provider for breastfeeding advice related to your particular situation. We do not warrant or assume any liability or responsibility for the accuracy or completeness of the information on this Site.