Product Description.:
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tablet , white , scored , round round
White to off-whiteDebossedLogo resembles a sigma symbolConcave
Gris-PEG?
(griseofulvin ultramicrosize) Tablets, USP 125 mg 250 mg
DRUG DESCRIPTION
Gris-PEG?Tablets contain ultramicrosize crystals of griseofulvin, an antibiotic derived froma species of Penicillium.
Each Gris-PEG tablet contains:
Active Ingredient: griseofulvin ultramicrosize .... 125 mg
Inactive Ingredients: colloidal silicon dioxide, lactose, magnesiumstearate, methylcellulose, methylparaben, polyethylene glycol 400 and 8000, polyvinylpyrrolidone, and titaniumdioxide.
OR
Active Ingredient: griseofulvin ultramicrosize .... 250 mg
Inactive Ingredients: colloidal silicon dioxide, magnesiumstearate, methylcellulose, methylparaben, polyethylene glycol 400 and 8000, povidone, sodiumlauryl sulfate, and titaniumdioxide.
INDICATIONS
Gris-PEG (griseofulvin ultramicrosize) is indicated for the treatment of the following ringworminfections tinea corporis (ringwormof the body), tinea pedis (athlete's foot), tinea cruris (ringwormof the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringwormof the scalp), and tinea unguium(onychomycosis, ringwormof 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, Microsporumaudouini, Microsporumcanis, Microsporumgypseumand 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.
SIDE EFFECTS
When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria, erythema multiform-like drug reactions, and rarely, angioneurotic edema, and may necessitate withdrawal of therapy and appropriate countermeasures. Paresthesias of the hands and feet have been reported rarely 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.
