Ketoconazole (ATC code: D01A C08) for topical administration is safety classified as Probably not porphyrinogenic because of minimal hepatic exposure. For more details of the metabolism of ketoconazole please refer to the monograph of ketoconazole for systemic use (ATC code: J02A B02).

Ketoconazole cream is indicated for the treatment of seborrheic eczema. Ketoconazole shampoo is indicated for the treatment of seborrheic dermatitis and dandruff on the scalp.

Insignificant

Plasma concentrations of ketoconazole were not detectable after topical administration of ketoconazole cream in adults on the skin. In one study in infants with seborrhoeic dermatitis (n = 19), where approximately 40 g of ketoconazole cream was applied daily on 40 % of the body surface area, plasma levels of ketoconazole were detected in 5 infants, ranging from 32 to 133 ng/mL (SPC), which is equivalent to < 1 µM hepatic exposure.

Uneventful use reported in 1 patient with acute porphyria.