Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2018 Publisher: Transdermal Limited, Merlin House, Brunel Road, Theale, Reading RG7 4AB, United Kingdom
The active ingredient of Grisol, griseofulvin, is an antifungal agent which, when applied topically in this formulation, penetrates the skin in the tissues of which it remains active against dermatophyte infections even after subsequent evaporation of the solvent system.
Grisol is active against dermatophytes including microsporum canis, trichophyton rubrum and trichophyton verrucosum.
Studies in humans have demonstrated no significant absorption.
When taken orally griseofulvin is metabolised by the liver mainly to 6-desmethyl- griseofulvin which is excreted in the urine. A large amount of an oral dose of griseofulvin is excreted unchanged in faeces and a small amount in urine; some is excreted in sweat.
Animal studies undertaken with respect to Grisol relate appropriately to local toxicity and absorption.
Twenty-eight day studies of the effects of griseofulvin, benzyl alcohol, acetone and isopropyl alcohol on the skin of rabbits showed few signs of dermal irritation.
Systemic absorption after topical administration of Grisol to shaved rats is poor, being approximately 20% in 24 hours. The data suggest a reduced systemic absorption in man by the topical route and a much more favourable distribution between the dermis and the skin.
In human volunteer studies, serum concentrations after topical administration of high doses are too small to be measured.
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