FULVICIN P/G 165- ultramicrosize griseofulvin_tablet

FULVICIN P/G Tablets are indicated for the treatment of ringworm infections of the skin, hair, and nails, namely: tinea corporis, tinea pedis, tinea cruris, tinea barbae, tinea capitis, tinea unguium (onychomycosis) when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitale, Trichophyton verrucosum, Trichophyton megninii, Trichophyton gallinae, Trichophyton crateriforme, Trichophyton sulphureum, Trichophyton schoenieinii, 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 this 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.

Accurate diagnosis of the infecting organism is essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium. Medication must be continued until the infecting organism is completely eradicated as indicated by appropriate clinical or laboratory examination. Representative treatment periods are tinea capitis, 4 to 6 weeks; tinea corporis, 2 to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium en dash depending on rate of growth en dash fingernails, at least 4 months; toenails, at least 6 months. 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 athlete’s foot, yeasts and bacteria may be involved as well as fungi. Griseofulvin will not eradicate the bacterial or monilial infection. Adults: Children: Children 2 years of age and younger en dash dosage has not been established. Clinical experience with griseofulvin in children with tinea capitis indicates that a single daily dose is effective. Clinical relapse will occur if the medication is not continued until the infecting organism is eradicated.

When adverse reactions occur, they are most commonly of the hypersensitivity type, such as skin rashes and urticaria, and rarely, angioneurotic edema and epidermal necrolysis (Lyell’s syndrome), 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, nephrosis, leukopenia, hepatic toxicity, GI bleeding, and menstrual irregularities 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.

This drug is contraindicated in patients with porphyria, hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin. Rare cases of conjoined twins have been reported in patients taking griseofulvin during the first trimester of pregnancy. Griseofulvin should not be prescribed to pregnant patients or to women contemplating pregnancy.

Prophylactic Usage: Since griseofulvin has demonstrated harmful effects in vitro Animal Toxicology 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 a colchicine-like effect on mitosis and cocarcinogenicity with methylcholanthrene in cutaneous tumor induction in laboratory animals. Griseofulvin interferes with chromosomal distribution during cell division, causing aneuploidy in plant and mammalian cells. These effects have been demonstrated in vitro Usage in Pregnancy: CONTRAINDICATIONS Animal Reproduction Studies: Suppression of spermatogenesis has been reported to occur in rats, but investigation in man failed to confirm this.

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FULVICIN P/G 165- ultramicrosize griseofulvin_tablet Product manual source documgent