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Grifulvin V (Griseofulvin) - Indications and Dosage

 



INDICATIONS AND USAGE

Major indications for GRIFULVIN V are:

Tinea capitis (ringworm of the scalp)

Tinea corporis (ringworm of the body)

Tinea pedis (athlete's foot)

Tinea unguium (onychomycosis; ringworm of the nails)

Tinea cruris (ringworm of the thigh)

Tinea barbae (barber's itch)

GRIFULVIN V inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as:

Trichophyton rubrum

Trichophyton tonsurans

Trichophyton mentagrophytes

Trichophyton interdigitalis

Trichophyton verrucosum

Trichophyton sulphureum

Trichophyton schoenleini

Microsporum audouini

Microsporum canis

Microsporum gypseum

Epidermophyton floccosum

Trichophyton megnini

Trichophyton gallinae

Trichophyton crateriform

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 antifungal agents alone.

It is not   effective in:

Bacterial infections

Candidiasis (Moniliasis)

Histoplasmosis

Actinomycosis

Sporotrichosis

Chromoblastomycosis

Coccidioidomycosis

North American Blastomycosis

Cryptococcosis (Torulosis)

Tinea versicolor

Nocardiosis

DOSAGE AND ADMINISTRATION

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--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 since in some forms of athlete's foot, yeasts and bacteria may be involved. Griseofulvin will not eradicate the bacterial or monilial infection.

Adults:   A daily dose of 500 mg. will give a satisfactory response in most patients with tinea corporis, tinea cruris, and tinea capitis.

For those fungus infections more difficult to eradicate such as tinea pedis and tinea unguium, a daily dose of 1.0 g is recommended.

Children:   Approximately 5 mg per pound of body weight per day is an effective dose for most children. On this basis the following dosage schedule for children is suggested:

Children weighing 30 to 50 pounds--125 mg to 250 mg daily.

Children weighing over 50 pounds--250 mg to 500 mg daily.

HOW SUPPLIED

GRIFULVIN V 250 mg Tablets in bottles of 100 (NDC 0062-0211-60) (white, scored, imprinted "ORTHO 211").

GRIFULVIN V 500 mg Tablets in bottles of 100 (NDC 0062-0214-60) and 500 (NDC 0062-0214-70) (white, scored, imprinted "ORTHO 214").

Dispense GRIFULVIN V Tablets in a tight container as defined in the USP.

GRIFULVIN V Suspension 125 mg per 5 mL in bottles of 4 fl oz (120mL) (NDC 0062-0206-04).

Dispense GRIFULVIN V Suspension in a tight, light-resistant container as defined in the USP.

STORE AT ROOM TEMPERATURE

Revised January 1997

631-10-560-2

Page last updated: 2006-05-05

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