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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 (see Pharmacology: Pharmacokinetics under Actions).
Plasma concentrations of ketoconazole were not detectable after topical administration of Ketoconazole shampoo 2% to the scalp of non-pregnant humans. Plasma levels were detected after topical administration of Ketoconazole shampoo 2% on the whole body. There are no known risks associated with the use of Ketoconazole shampoo 2% in pregnancy or lactation.
