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|Product Name:||Griseofulvin Tablets||Composition:||Each Tablet Contains: Griseofulvin 500 Mg|
|Indications:||Mycotic Diseases Of The Skin, Hair And Nails Due To Microsporum, Trichophyton, Or Epidermophyton Respond To Griseofulvin Therapy.||Storage Instructions:||Store In Airtight, Well-closed Containers Below 30°C.|
|Expiration Date:||3 Years|
Each tablet contains 500mg of griseofulvin.
Griseofulvin is fungistatic in vitro for various species of the dermatophytes Microsporum, Epidermophyton and Trichophyton. The drug has no effect on bacteria or on other fungi.
A prominent morphologic manifestation of the action of griseofulvin is the production of multinucleate cells as the drug inhibits fungal mitosis. Griseofulvin causes disruption of the mitotic spindle by interacting with polymerized microtubules. Although the effects of the drug are thus similar to those of colchicine and the vinca alkaloids, its binding sites on the microtubular protein are distinct. There is evidence that griseofulvin binds to a microtubule-associated protein in addition to its binding to tubulin.
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.
Porphyria. It may precipitate an acute attack.
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.
DOSAGE AND DIRECTIONS FOR USE:
Adults: 500 mg to 1g 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 at 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.
SIDE EFFECTS AND SPECIAL PRECAUTIONS:
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.
Angioderma, 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.
Store in airtight, well-closed containers below 30°C.