There are no adequate and well-controlled studies in pregnant or lactating women. Data on a limited number of exposed pregnancies indicate no adverse effects of topical ketoconazole on pregnancy or on the health of the foetus/newborn child. Animal studies have shown reproductive toxicity at doses that are not relevant to the topical administration of ketoconazole. No effects on the breastfed newborn/infant are anticipated.
Plasma concentrations of ketoconazole were not detectable after topical administration of Dermazole shampoo to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Dermazole shampoo on the whole body. There are no known risks associated with the use of Dermazole shampoo in pregnancy or lactation.