Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2011 Publisher: Brown &Burk UK Ltd, 5 Marryat Close, Hounslow West, Middlesex, TW4 5DQ, United Kingdom
The treatment of fungal infections of the skin, scalp, hair, or nails (Tinea barbae, Tinea capitis, Tinea corporis, Tinea cruris, Tinea pedis, Tinea unguium) where topical therapy is considered inappropriate, or the infection has proven refractory to topical therapy.
Oral administration of griseofulvin for systemic therapy of fungal infections enables newly formed keratin of the skin, hair, and nails to resist fungal attack. As the new keratin extends, the old infected keratin is shed.
Prior to therapy, the type of fungi responsible should be identified. The use of griseofulvin is not justified in the treatment of minor or trivial infections that will respond to topical therapy.
Before prescribing Griseofulvin Tablets, consideration should be given to national and/or local guidance on the appropriate use of antifungals.
For oral administration.
Tablets should be swallowed whole with a glass of water. Griseofulvin is recommended to be taken after a high fat meal, for increased absorption and minimising GI distress, see section 5.2.
General measures in regard to hygiene should be observed to control sources of infection or reinfection. Concomitant use of appropriate topical agents is usually required, particularly in treatment of tinea pedis. In some forms of tine pedis, yeasts and bacteria may be involved as well as fungi. Griseofulvin will not eradicate the bacterial or candidial infections.
The usual adult dose is 500 mg to 1000 mg daily. The dose should not be less than 10 mg/Kg bodyweight/day. The dose may be administered as a single daily dose, or it may be administered twice daily.The twice daily dosing regimen may be more effective in those patients who respond poorly.
Griseofulvin is contraindicated in patients with severe hepatic impairment, see section 4.3.
For patients with moderate to mild hepatic impairment, no dosage adjustment is required. However griseofulvin may lead to further impairment of hepatic function, therefore regular monitoring of liver function is mandated, see section 4.4.
No dosage adjustment is required in renally impaired patients; renal insufficiency does not lead to accumulation.
No dosage adjustment is required in the elderly. Consideration should be given that such patients may also have a degree of hepatic impairment, see section 4.4.
The dosage form, film-coated tablet, is only suitable for children of an age to swallow the tablet.
The usual dose in 10 mg/Kg bodyweight/day, in divided doses.
The duration of theapy depends upon the thickness of keratin at the site of infection, and the clinical response. The following duration of therapy are indicative:
Tinea corporis: 2-4 weeks
Tinea capitis: 4-8 weeks, in refractory cases, 8-12 weeks
Tinea pedis: 4-8 weeks
Tinea unguium: 6-12 months
Therapy should be continued for at least two weeks after all signs of infection have disappeared.
No case of overdose has been reported.
The likely symptoms of any overdose would be nausea, nomiting, headache, numbness and tingling, confusion, and vertigo. Urticaria or porphyria could occur.
There is no specific antidote to griseofulvin. Gastric lavage, or the induction of emesis may be of help, if ingestion is recent. Administration of activated charcoal may also be of use. Treatment should be symptomatic and supportive. Laboratory monitoring of haemopoetic, hepatic and nephritic parameters and electrolytes is recommended.
Unopened container: 36 Months.
Opened container: 6 Months.
Do not store above 25°C.
Polypropylene (PP) tablet container with linear low density polyethylene (LLDPE) screw closure.
Tablet containers with 90 tablets.
Not all pack sizes may be marketed.
Any unused product or waste material should be disposed of in accordance with local requirements.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
