GRISOVIN

What it is

Grisovin is available as 125 mg and 500 mg tablets, each containing griseofulvin B.P (fine particle). Griseofulvin is an antifungal produced by Penicillium griseofulvum and other species of Penicillium.

Approved indications

— Treatment of fungal infections of the skin, scalp, hair or nails, where topical therapy is considered inappropriate or has failed.

Dosing overview

The usual recommended dosage for adults is 500 mg per day. In certain infections higher doses are necessary; for nail infections some patients may require up to 1000 mg daily until a response is apparent, at which time the dose may be reduced to 500 mg per day. The usual dose for children is 10 mg/kg body weight daily, in divided doses. Doses should be taken after meals otherwise absorption is likely to be inadequate; absorption is increased when Grisovin is taken with a high-fat meal. For hair or skin at least four weeks treatment is required, whereas toe or finger nails may need six to twelve months treatment, and therapy should be continued for at least two weeks after all signs of infection have disappeared.

Key safety warnings

Concurrent treatment with griseofulvin may reduce the effectiveness of oral contraceptives, so additional non-hormonal contraceptive precautions should be taken during griseofulvin treatment and for a month after stopping griseofulvin. Since a photosensitivity reaction is occasionally associated with griseofulvin therapy, patients should be warned to avoid exposure to intense natural or artificial sunlight. Headache is a minor effect with incidence as high as 15%, sometimes severe, but usually disappears as therapy is continued. Haematological effects include leukopenia and neutropenia; blood studies should be carried out at least once a week during the first month of treatment or longer, and administration of the drug should be discontinued if granulocytopenia occurs. Proteinuria, nephrosis, hepatotoxicity and menstrual irregularities have been reported rarely in patients receiving griseofulvin. Patients should be warned that an enhancement of the effects of alcohol by griseofulvin has been reported.

Contraindications

Grisovin is contraindicated in hypersensitivity to any ingredient of the preparation. Grisovin is contraindicated in pregnancy and in women intending to become pregnant within one month following cessation of treatment. Men should not father children within six months of treatment. Griseofulvin is contraindicated in established porphyria and systemic lupus erythematosus. Grisovin is contraindicated in severe liver disease and hepatocellular failure, as griseofulvin may cause liver disease to worsen and liver function should be monitored in such conditions.

PBS listing

Both the 125 mg and 500 mg tablets are listed on the PBS with unrestricted access; the 500 mg tablet has an ex-manufacturer price of A$10.52, and the 125 mg tablet has an ex-manufacturer price of A$9.93.

Regulatory history

The 125 mg tablet was first listed on the ARTG in 1991, and the 500 mg tablet was first listed on the ARTG in 2009. The product information was first approved on 24 August 1995 and was last revised on 30 October 2023.