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Dosage Form, Composition & NAFDAC Registration Number (NRN)
Tablet (NRN: 5379): Griseofulvin BP 500 mg.
G-Cin is an oral fungicidal antibiotic derived from a species of Penicillin and used for the treatment of superficial mycoses. G-Cin is active in-vitro against various species of Microsporum, Epidermophyton and Tricophyton. It has no effect on bacteria or on other genera of fungi such as Candida albicans (thrush fungus), Aspergilus and Malasselzia furfur (Pityriasis versicolor).
G-Cin is deposited in the keratin precursor cells and has a greater affinity for diseased tissues. It enables newly formed keratin of the skin hair and nails to resist attack by fungi.
G-Cin is effective against the dermatophytes causing Ringworm (tinea) infections of the skin, hair and nail including Microsporum canis, Trichophyton rubrum and T. verrucosum.
It is generally given for such infections that involve the scalp, hair, nails and skin which do not respond to topical treatment.
G-Cin is contraindicated in patients with porphyria, liver failure and in individuals with a history of hypersensitivity to Griseofulvin.
Concurrent treatment with G-Cin may reduce the effectiveness of oral contraceptives. So additional contraceptive precautions should be taken during G-Cin treatment and for a month after stopping it. As there is no evidence of its safety in human pregnancy (Griseofulvin is teratogenic in animals and some case reports suggest that it produces human foetal abnormalities)
G-Cin should not be used in pregnancy.
Griseofulvin decrease the activity of Warfarin type anticoagulants. Patients receiving these drugs concomitantly may require dosage adjustment of the anticoagulants during and after G-Cin therapy.
Barbiturates actually depress Griseofulvin activity and concomitant administration may require a dosage adjustment of the antifungal agent
The effect of alcohol may be potentiated by Griseofulvin, producing such effects as tachycardia and flush.
When adverse reactions occur, they are commonly of the hypersensitivity type such as skin rashes, urticaria and rarely angioneurotic edema.
Other side effects reported occasionally are gastric discomfort, headache, dizziness and insomnia, dryness of mouth, an altered sensation of taste. Proteinuria and leukopenia have been reported rarely. Administration of drug should be discontinued if granulocytopenia occurs.
Dosage & Administration
Doses should be taken after meals, otherwise absorption is likely to be inadequate.
Normally 500 to 1000 mg daily, but not less than 10 mg/kg body weight daily. A single dose is often satisfactory but divided doses may be more effective in patients who respond poorly.
Usually 10 mg/kg body weight daily in divided doses.
The duration of treatment depends upon the thickness of keratin at the site of infection:
- 2 to 6 weeks for infection of hair & skin;
- 6 to 9 months for infections of the finger nails and
- 12 to 18 months of infections of the toe nails.
Store in cool and dry place. Protect from light.
Keep the medicines out of reach of children.