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 anti-fungal agents alone.

It is not effective in:

Bacterial infections
Candidiasism (Moniliasis)
Histoplasmosis
Actinomycosis
Sporotrichosis
Chromoblastomycosis
Coccidioidomycosis
North American Blastomycosis
Cryptococcosis (Torulosis)
Tinea versicolor
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, 2to 4 weeks; tinea pedis, 4 to 8 weeks; tinea unguium - depending on rate of growth - fingernails, at least 4 months; toenails, at least 6months.

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 gram 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 - 250mg to 500 mg daily.

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 (120 mL) (NDC 0062-0206-04).

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

STORE AT ROOM TEMPERATURE

DERMATOLOGICAL DIVISION, ORTHO PHARMACEUTICAL CORPORATION, Raritan, New Jersey 08869. Revised January 1997. FDA Rev date: n/a

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