Data from FDA - Curated by EPG Health - Last updated 10 January 2017

Indication(s)

INDICATIONS AND USAGE Major indications for Griseofulvin Oral Suspension are: Griseofulvin inhibits the growth of those genera of fungi that commonly cause ringworm infections of the hair, skin, and nails, such as: 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:

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Advisory information

contraindications
CONTRAINDICATIONS This drug is contraindicated in patients with porphyria, hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin. Two 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.
Special warnings and precautions

PRECAUTIONS Patients on prolonged therapy with any potent medication should be under close observation.

Periodic monitoring of organ system function, including renal, hepatic and hemopoietic, should be done.

Since griseofulvin is derived from species of penicillin, the possibility of cross sensitivity with penicillin exists; however, known penicillin-sensitive patients have been treated without difficulty.

Since a photosensitivity reaction is occasionally associated with griseofulvin therapy, patients should be warned to avoid exposure to intense natural or artificial sunlight.

Should a photosensitivity reaction occur, lupus erythematosus may be aggravated.

Drug Interactions Patients on warfarin-type anticoagulant therapy may require dosage adjustment of the anticoagulant during and after griseofulvin therapy.

Concomitant use of barbiturates usually depresses griseofulvin activity and may necessitate raising the dosage.

The concomitant administration of griseofulvin has been reported to reduce the efficacy of oral contraceptives and to increase the incidence of breakthrough bleeding.

Adverse reactions

ADVERSE REACTIONS When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria and rarely, angioneurotic edema or erythema multiforme-like drug reaction, 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.

Usage information

Dosing and administration

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 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:

More information

Category Value
Authorisation number ANDA065394
Agency product number 32HRV3E3D5
Orphan designation No
Product NDC 42254-306
Date Last Revised 26-09-2012
Type HUMAN PRESCRIPTION DRUG
RXCUI 239238
Marketing authorisation holder Rebel Distributors Corp