(Griseofulvin Tablet BP 500mg)
Medical Information. To be read carefully.
Each uncoated tablet contains: Griseofulvin BP 500 mg
BIOMESOVIN is an oral fungistatic antibiotic derived from a species of Penicillium and used for the treatment of superficial mycoses.
BIOMESOVIN is active in vitro against various species of Microsporum, Epidermophyton and Trichophyton.
It has no effect on bacteria or on other genera of fungi, such as Candida albicans (“thrush fungus”), Aspergilus and Malassezia furfur (Pityriasis versicolor).
BIOMESOVIN 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.
BIOMESOVIN is effective against the dermatophytes causing ringworm (tinea) infections of the skin, hair and nails including Microsporum canis, Trichophyton rubrum and T. verrucosum.
DOSAGE AND MODE OF ADMINISTRATION
Doses should be taken after meals, otherwise absorption is likely to be inadequate.
Adults: normally 500 to 1,000 mg daily, but not less than 10 mg/kg body weight daily.
A single dose daily is often satisfactory but divided doses may be more effective in patients who respond poorly.
Children: usually 10 mg per kg body weight daily in divided doses.
The duration of treatment 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 finger nails may need six to twelve months’ treatment.
Therapy should be continued for at least two weeks after all signs of infection have disappeared.
or as directed by the physician.
BIOMESOVIN is contraindicated in patients with porphyria, hepatocellular failure and in individuals with a history of hypersensitivity to griseofulvin.
– Concurrent treatment with griseofulvin may reduce the effectiveness of oral contraceptives, so additional contraceptive precautions should be taken during BIOMESOVIN 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), BIOMESOVIN should not be used in pregnancy.
– Biomesovin decreases the activity of warfarin-type anticoagulants so that patients receiving these drugs concomitantly may require dosage adjustment of the anticoagulant during and after BIOMESOVIN therapy.
– Barbiturates usually 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 most 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.
– Proteinuria and leukopenia have been reported rarely. Administration of the drug should be discontinued if granulocytopenia occurs.
STORAGE AND VALIDITY
Store away from light and in a cool dry place.
Do not exceed the expiry date mentioned on the package.
The drug shall only be dispensed by or on the prescription of a physician.
KEEP OUT OF REACH OF CHILDREN.
BIOMESOVIN Tablets are supplied in packs of 20 and 250 tablets.
Bharat Parenterals Ltd.
Vill. Haripura, Ta. Savli, Dist.
Vadodara – 391 520, Gujarat, India.
No 16 Anionwu Street Odoakpu
P.O. Box 7846 Onitsha, Nigeria.