Ultramicrosize Griseofulvin
Generic: ULTRAMICROSIZE GRISEOFULVIN
Basic Information
Manufacturer
Sigmapharm Laboratories, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
37b4d132-84f1-4394-b468-7e74eeec61eb
Indications & Usage
INDICATIONS AND USAGE Ultramicrosize Griseofulvin Tablets, USP are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum .
NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified.
The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone.
Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.
NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified.
The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone.
Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.
Warnings
WARNINGS Prophylactic Usage - Safety and efficacy of griseofulvin for prophylaxis of fungal infections have not been established.
Serious Skin Reactions Severe skin reactions (e.g, Stevens-Johnson syndrome, toxic epidermal necrolysis) and erythema multiforme have been reported with griseofulvin use.
These reactions may be serious and may result in hospitalization or death.
If severe skin reactions occur, griseofulvin should be discontinued (see ADVERSE REACTIONS section).
Hepatotoxicity Elevations in AST, ALT, bilirubin, and jaundice have been reported with griseofulvin use.
These reactions may be serious and may result in hospitalization or death.
Patients should be monitored for hepatic adverse events and discontinuation of griseofulvin considered if warranted (see ADVERSE REACTIONS section).
Animal Toxicology - Chronic feeding of griseofulvin, at levels ranging from 0.5%-2.5% of the diet resulted in the development of liver tumors in several strains of mice, particularly in males.
Smaller particle sizes result in an enhanced effect.
Lower oral dosage levels have not been tested.
Subcutaneous administration of relatively small doses of griseofulvin once a week during the first three weeks of life has also been reported to induce hepatomata in mice.
Thyroid tumors, mostly adenomas but some carcinomas, have been reported in male rats receiving grisoefulvin at levels of 2.0%, 1.0% and 0.2% of the diet, and in female rats receiving the two higher dose levels.
Although studies in other animal species have not yielded evidence of tumorigenicity, these studies were not of adequate design to form a basis for conclusion in this regard.
In subacute toxicity studies, orally administered griseofulvin produced hepatocellular necrosis in mice, but this has not been seen in other species.
Disturbances in porphyrin metabolism have been reported in griseofulvin-treated laboratory animals.
Griseofulvin has been reported to have colchicine-like effect on mitosis and cocarcinogenicity with methylcholanthrene in cutaneous tumor induction in laboratory animals.
Usage in Pregnancy - see CONTRAINDICATIONS section.
Animal Reproduction Studies - It has been reported in the literature that griseofulvin was found to be embryotoxic and teratogenic on oral administration to pregnant rats.
Pups with abnormalities have been reported in the litters of a few bitches treated with griseofulvin.
Suppression of spermatogenesis has been reported to occur in rats, but investigation in man failed to confirm this.
Serious Skin Reactions Severe skin reactions (e.g, Stevens-Johnson syndrome, toxic epidermal necrolysis) and erythema multiforme have been reported with griseofulvin use.
These reactions may be serious and may result in hospitalization or death.
If severe skin reactions occur, griseofulvin should be discontinued (see ADVERSE REACTIONS section).
Hepatotoxicity Elevations in AST, ALT, bilirubin, and jaundice have been reported with griseofulvin use.
These reactions may be serious and may result in hospitalization or death.
Patients should be monitored for hepatic adverse events and discontinuation of griseofulvin considered if warranted (see ADVERSE REACTIONS section).
Animal Toxicology - Chronic feeding of griseofulvin, at levels ranging from 0.5%-2.5% of the diet resulted in the development of liver tumors in several strains of mice, particularly in males.
Smaller particle sizes result in an enhanced effect.
Lower oral dosage levels have not been tested.
Subcutaneous administration of relatively small doses of griseofulvin once a week during the first three weeks of life has also been reported to induce hepatomata in mice.
Thyroid tumors, mostly adenomas but some carcinomas, have been reported in male rats receiving grisoefulvin at levels of 2.0%, 1.0% and 0.2% of the diet, and in female rats receiving the two higher dose levels.
Although studies in other animal species have not yielded evidence of tumorigenicity, these studies were not of adequate design to form a basis for conclusion in this regard.
In subacute toxicity studies, orally administered griseofulvin produced hepatocellular necrosis in mice, but this has not been seen in other species.
Disturbances in porphyrin metabolism have been reported in griseofulvin-treated laboratory animals.
Griseofulvin has been reported to have colchicine-like effect on mitosis and cocarcinogenicity with methylcholanthrene in cutaneous tumor induction in laboratory animals.
Usage in Pregnancy - see CONTRAINDICATIONS section.
Animal Reproduction Studies - It has been reported in the literature that griseofulvin was found to be embryotoxic and teratogenic on oral administration to pregnant rats.
Pups with abnormalities have been reported in the litters of a few bitches treated with griseofulvin.
Suppression of spermatogenesis has been reported to occur in rats, but investigation in man failed to confirm this.
Adverse Reactions
ADVERSE REACTIONS There have been post-marketing reports of severe skin and hepatic adverse events associated with griseofulvin use (see WARNINGS section).
When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema, and may necessitate withdrawal of therapy and appropriate countermeasures.
Paresthesia of the hands and feet have been reported after extended therapy.
Other side effects reported occasionally are oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, mental confusion, and impairment of performance of routine activities.
Proteinuria and leukopenia have been reported rarely.
Administration of the drug should be discontinued if granulocytopenia occurs.
When rare, serious reactions occur with griseofulvin, they are usually associated with high dosages, long periods of therapy, or both.
To report SUSPECTED ADVERSE REACTIONS, contact Sigmapharm Laboratories, LLC, Pharmacovigilance at 1-855-332-0731 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema, and may necessitate withdrawal of therapy and appropriate countermeasures.
Paresthesia of the hands and feet have been reported after extended therapy.
Other side effects reported occasionally are oral thrush, nausea, vomiting, epigastric distress, diarrhea, headache, fatigue, dizziness, insomnia, mental confusion, and impairment of performance of routine activities.
Proteinuria and leukopenia have been reported rarely.
Administration of the drug should be discontinued if granulocytopenia occurs.
When rare, serious reactions occur with griseofulvin, they are usually associated with high dosages, long periods of therapy, or both.
To report SUSPECTED ADVERSE REACTIONS, contact Sigmapharm Laboratories, LLC, Pharmacovigilance at 1-855-332-0731 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.