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Gris Peg

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Gris Peg

Gris Peg

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.

DOSAGE AND ADMINISTRATION

Accurate diagnosis of infecting organismis essential. Identification should be made either by direct microscopic examination of a mounting of infected tissue in a solution of potassiumhydroxide or by culture on an appropriate medium. Medication must be continued until the infecting organismis 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-depending on rate of growth-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.

GRIS-PEG® (griseofulvin) tablets may be swallowed whole or crushed and sprinkled onto 1 tablespoonful of applesauce and swallowed immediately without chewing.

Adults: Daily administration of 375 mg (as a single dose or in divided doses) will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis. For those fungal infections more difficult to eradicate, such as tinea pedis and tinea unguium, a divided dose of 750 mg is recommended.

Pediatric Use: Approximately 3.3 mg per pound of body weight per day of ultramicrosize griseofulvin is an effective dose for most pediatric patients. On this basis, the following dosage schedule is suggested: Children weighing 35-60 pounds - 125 mg to 187.5 mg daily. Pediatric patients weighing over 60 pounds - 187.5 mg to 375 mg daily. Children and infants 2 years of age and younger-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 organismis eradicated.

HOW SUPPLIED

Gris-PEG®(griseofulvin ultramicrosize) Tablets, 125 mg, white scored, elliptical-shaped, embossed “Gris-PEG” on one side and “125” on the other. Gris-PEG (griseofulvin ultramicrosize) Tablets, 250 mg, white scored, capsule-shaped, embossed “Gris-PEG” on one side and “250” on the other. The 125 mg strength is available in bottles of 100 (NDC 0884-0763-04). The 250 mg strength is available in bottles of 100 and 500 (NDC 0884-0773-04 and NDC 0884-0773-50 respectively). Both strengths are film-coated.

Storage

Store Gris-PEG tablets at controlled roomtemperature 15° -30° C (59° -86° F) in tight, light-resistant containers.

Manufactured for: PEDINOL PHARMACAL INC. Farmingdale, NY 11735 U.S.A. By: NOVARTIS CONSUMER HEALTH INC. Lincoln, NE 68501, REV 01/07. FDA revision date: 1/24/2007

Last reviewed on RxList: 2/18/2008
This monograph has been modified to include the generic and brand name in many instances.

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