Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Janssen-Cilag Ltd, 50-100 Holmers Farm Way, High Wycombe, Bucks, HP12 4EG, UK
Pharmacotherapeutic group: Imidazole and triazole derivatives
ATC Code: D01AC08
Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes. Its broad spectrum of activity is already well known.
Plasma concentrations of ketoconazole were not detectable after topical administration of Nizoral 2% shampoo on the scalp. Plasma levels were detected after topical administration of Nizoral 2% shampoo on the whole body.
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.
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