Last update Sept. 1, 2022
Very Low Risk
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)
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.
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e-lactancia is a resource recommended by Asociación Española de Bancos de Leche Humana of Spain
Would you like to recommend the use of e-lactancia? Write to us at corporate mail of APILAM