Ketoconazole Tablet while Breastfeeding

What is Ketoconazole Tablet used for?

Is Ketoconazole Tablet usage safe while breastfeeding? If a lactating mother is using it can there be any effect on growth or development of infant?

Ketoconazole while Breastfeeding

CAS Number: 65277-42-1

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.

Ketoconazole while Breastfeeding

CAS Number: 65277-42-1

Because there is little published experience with ketoconazole during breastfeeding and its potential liver enzyme inhibition and liver toxicity, other agents may be preferred. However, if oral ketoconazole 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 ketoconazole. Use of ketoconazole 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]

I already used Ketoconazole Tablet and meanwhile I breastfed my baby should I be concerned?

I am nursing mother and my doctor has suggested me to use Ketoconazole Tablet, is it safe?

If I am using Ketoconazole Tablet, will my baby need extra monitoring?

Who can I talk to if I have questions about usage of Ketoconazole Tablet in breastfeeding?