GRISEOFULVIN

Posology Adults Normally 500 to 1000 mg daily, but not less than 10 mg/kg bodyweight daily. A single dose daily is often satisfactory, but divided doses may be more effective in patients who respond poorly. Paediatric population Usually 10 mg/kg (5 mg/lb) body weight daily in divided doses.

Duration of Treatment This depends upon the thickness of keratin at the site of infection. For hair or skin at least four weeks treatment is required, whereas toe or fingernails may need six to twelve months treatment. Therapy should be continued for at least two weeks after all signs of infection have disappeared.

Method of administration For oral administration. Doses should be taken after meals, otherwise absorption is likely to be inadequate.

Diarrhoea, nausea and vomiting are common adverse events. Headache and gastric discomfort sometimes occur, but usually disappear as treatment continues. On rare occasions urticarial reactions, skin rashes and precipitation of Systemic Lupus Erythematosus have been reported.

Toxic epidermal necrolysis and erythema multiforme have been reported. Significant elevations in LFTs (greater than three times the upper limit of normal) have been reported very rarely. g. confusion, dizziness, impaired co-ordination and peripheral neuropathy.

Leucopenia with neutropenia has been reported. Photosensitivity reactions can occur on exposure to intense natural or artificial sunlight. Drowsiness has been reported. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store

Porphyria or severe liver disease. Griseofulvin may cause liver disease to deteriorate, and liver function should be monitored in such conditions. Systemic Lupus Erythematosus: griseofulvin has been reported to exacerbate the condition.

1. There is no evidence of the safety of Griseofulvin in human pregnancy. Griseofulvin is teratogenic in animals and some case reports of human foetal abnormalities have been observed. Therefore, Griseofulvin should not be used in pregnancy, or in women intending to become pregnant within one month following cessation of treatment.

Males should not father children within six months of treatment with Griseofulvin. Long term administration of high doses of griseofulvin with food has been reported to induce hepatomas in mice and thyroid tumours in rats but not hamsters.

The clinical significance of these findings in man is not known. In view of these data, Griseofulvin tablets should not be used prophylactically.