Each uncoated tablet contains: Griseofulvin BP 125mg.
Mycotic diseases of the skin, hair and nails due to Microsporum, Trichophyton, or Epidermophyton respond to griseofulvin therapy.
It must be stressed that, since other fungal diseases are not affected by the medicine, careful mycological study with identification of the responsible organism is the only basis on which therapy can be selected accurately.
Also infections of the hair (tinea capitis) caused by M. canis, M. audouini, T. schoenleini, and T. verrucosum; "ringworm" of the glabrous skin; tinea cruris and tinea corporis caused by M. canis, T. rubrum, T. verrucosum and E. floccosum; and tinea of the hands (T. rubrum, T. mentagrophytes) and beard (Trichophyton species) are readily treatable with griseofulvin.
Griseofulvin also is highly effective in "athlete's foot" or epidermophytosis involving the skin and nails, the vesicular form of which is most commonly due to T. mentagrophytes and the hyperkeratotic type to T. rubrum. Trichophyton rubrum and T. mentagrophytes infections may require higher-than-conventional doses.
Adults: 500 mg to 1 g per 24 hours. Doses of 1.5 g to 2.0 g per 24 hours may be used for short periods in severe or extensive infections.
Children: 10 mg/kg per 24 hours.
Take with or after meals, especially fatty meals, in order to minimise possible gastrointestinal irritation and to increase absorption.
Best results are obtained when the daily dose is divided and given an 6-hour intervals. Treatment must be continued until infected tissue is replaced by normal hair, skin or nails, which requires 2-6 months for skin and hair infections, 6 to 9 months for fingernails, and at least a year for toenails.
The symptoms of overdosage are those stated under side-effects and in these cases the dosage should be reduced or the medicine discontinued. Treatment is supportive and symptomatic.
Porphyria. It may precipitate an acute attack. Liver failure. Pregnancy. Griseofulvin crosses the placenta and it has been shown to be embryo toxic and teratogenic in rats. Hypersensitivity to griseofulvin.
Men receiving griseofulvin should not father children within six months of treatment. The warning is based on data from in vitro studies using mammalian cells which demonstrated aneuploidy. Griseofulvin may impair the ability to drive or operate machinery and has been reported to enhance the effects of alcohol. Use with extreme caution in patients with systemic lupus erythematosus, as griseofulvin may precipitate or aggravate it.
Use is contraindicated during pregnancy.
Side-effects are usually mild and transient. They consist of headache, skin rashes, dryness of the mouth, an altered sensation of taste, and gastrointestinal disturbances.
Angioedema, erythema multiform, toxic epidermal necrolysis, proteinuria, leucopenia and other blood dyscrasias, candidiasis, paraesthesia, photosensitisation, and severe headache have been reported occasionally. Depression, confusion, dizziness, insomnia, and fatigue have also been reported.
Reports of hepatotoxicity have been attributed to griseofulvin. Oral thrush, granulocytopenia or leucopenia and peripheral neuritis can also occur less frequently.
Phenobarbitone has been reported to decrease the gastrointestinal absorption of griseofulvin. Griseofulvin may increase the rate of metabolism and diminish side effects of some drugs such as coumarin anticoagulants and oral contraceptives. Use of an alternate or additional means of contraception if taking oestrogen-containing oral contraceptives concurrently with griseofulvin and for one month after stopping griseofulvin therapy is advisable. Griseofulvin has also been reported to reduce the plasma concentrations of salicylate in patients taking aspirin.
Since griseofulvin is derived from a species of Penicillium, it is theoretically possible that patients intolerant to penicillins or penicillamine may be intolerant of griseofulvin also. However, cross-sensitivity between griseofulvin and penicillins or penicillamine has not been clinically substantiated. In addition penicillin-sensitive patients have received griseofulvin without difficulty.
Keep in a cool, dry place. Store at a temperature not exceeding 30°C.
D01BA01 - griseofulvin ; Belongs to the class of antifungals for systemic use.
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