Composition: Each tablet contains:
Griseofulvin . . . . . . . . . . . . . . . . . . . . . . 500 mg
Cardboard box containing 2 blisters of 10 tablets.
Griseofulvin is indicated for the treatment of dermatophyte infections of the skin, hair, or nails which do not respond to topical treatment including tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium caused by susceptible strains of Trichophyton sp., Microsporum sp., or Epidermophyton sp..
|Dosage and administration||
Hypersensitivity to griseofulvin or any of excipients of the drug.
|Warnings and precautions for use||
Griseofulvin may cause severe toxicity. When the treatment with griseofulvin is prolonged hepatic, renal and hematopoietic function should be periodically monitored.
|Recommendation for pregnancy and breastfeeding||
|Effects on ability to drive and use machines||
Griseofulvin can cause headaches, fatigue, drowsiness, dizziness, and impaired co-ordination, which influence the ability to drive and use machines. If affected, patients should not perform activities that require alertness.
|Interactions, incompatibilities of medicine||
Alcohol: Concomitant use of griseofulvin with alcohol may cause fast heartbeat, flushing, increased sweating.
|Undesirable effects (ADRs)||
Undesirable effects are usually mild and transient.
|Overdose and management||
There is no specific antidote.
Griseofulvin is a fungistatic antibiotic obtained from culture of Penicillium griseofulvum or by other methods. The fungistatic action of griseofulvin is primarily due to disruption of mitotic spindle structure of the fungal cell, which causes an arrest of metaphase of cell division, inhibiting the division of fungal cells. It has also been proposed that griseofulvin causes the production of defective DNA, which is then unable to replicate. Griseofulvin is deposited in the keratin precursor cells and has a greater affinity for diseased tissue. The drug is tightly bound to the new keratin which becomes highly resistant to fungal invasions. Infected skin, hair and nails will be replaced by noninfected tissues. Griseofulvin is effective against skin infections that are widespread and difficult to treat. Griseofulvin inhibits the development of dermatophytes caused by Trichophyton species (especially T. rubrum, T. tonsurans, T. mentagrophytes, T. verrucosum, T. megninii, T. gallinae and T. schoenleinii), Microsporum (M. audouinii, M. canis, M. gypseum) and Epidermophyton floccosum.
After oral administration, absorption of griseofulvin varies from 25% to 70%. The absorption increases significantly if griseofulvin is taken with or after high-fat meals. Peak plasma levels are achieved within 4 hours and are maintained for some 10 to 20 hours.
|Storage conditions, shelf-life, quality specification of the medicine||
Storage conditions: Protect from humidity and light, below 30 degrees C.