Griseofulvin 125 MG Oral Tablet [Gris-PEG]


Prophylactic Usage Safety and efficacy of griseofulvin for prophylaxis of fungal infections have not been established.

Serious Skin Reactions Severe skin reactions (e.g.

Stevens-Johnson syndrome, toxic epidermal necrolysis) and erythema multiforme have been reported with griseofulvin use.

These reactions may be serious and may result in hospitalization or death.

If severe skin reactions occur, griseofulvin should be discontinued (see ADVERSE REACTIONS section).

Hepatotoxicity Elevations in AST, ALT, bilirubin, and jaundice have been reported with griseofulvin use.

These reactions may be serious and may result in hospitalization or death.

Patients should be monitored for hepatic adverse events and discontinuation of griseofulvin considered if warranted (see ADVERSE REACTIONS section).

Animal Toxicology Chronic feeding of griseofulvin, at levels ranging from 0.5%-2.5% of the diet resulted in the development of liver tumors in several strains of mice, particularly in males.

Smaller particle sizes result in an enhanced effect.

Lower oral dosage levels have not been tested.

Subcutaneous administration of relatively small doses of griseofulvin once a week during the first three weeks of life has also been reported to induce hepatomata in mice.

Thyroid tumors, mostly adenomas but some carcinomas, have been reported in male rats receiving griseofulvin at levels of 2.0%, 1.0% and 0.2% of the diet, and in female rats receiving the two higher dose levels.

Although studies in other animal species have not yielded evidence of tumorigenicity, these studies were not of adequate design to form a basis for conclusion in this regard.

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.

Usage in Pregnancy – see CONTRAINDICATIONS section.

Animal Reproduction Studies It has been reported in the literature that griseofulvin was found to be embryotoxic and teratogenic on oral administration to pregnant rats.

Pups with abnormalities have been reported in the litters of a few bitches treated with griseofulvin.

Suppression of spermatogenesis has been reported to occur in rats, but investigation in man failed to confirm this.


Gris-PEG ® Tablets contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium .

The chemical name of griseofulvin, USP is 7-Chloro-2’, 4,6-trimethoxy-6’ β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione.

Its structural formula is: C 17 H 17 ClO 6 M.W.

352.77 Griseofulvin, USP occurs as a white to creamy white, odorless powder which is very slightly soluble in water, soluble in acetone, dimethylformamide, and chloroform and sparingly soluble in alcohol.

Each Gris-PEG tablet contains: Active Ingredient: griseofulvin ultramicrosize ….

125 mg Inactive Ingredients: Polyethylene Glycol 8000, Lactose Monohydrate, Colloidal Silicon Dioxide, Crospovidone, Magnesium Stearate, Methylparaben, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol 3350, and Talc.

OR Active Ingredient: griseofulvin ultramicrosize … 250 mg Inactive Ingredients: Polyethylene Glycol 8000, Magnesium Stearate, Sodium Lauryl Sulfate, Methylparaben, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol 3350, and Talc.

Description: formula


Gris-PEG ® (griseofulvin ultramicrosize) Tablets, 125 mg, white scored, elliptical-shaped, embossed “Gris-PEG” on one side and “125” on the other.

The 125 mg strength is film-coated and is available in bottles of 100 (NDC 0884-0763-04).

Gris-PEG (griseofulvin ultramicrosize) Tablets, 250 mg, white scored, capsule-shaped, embossed “Gris-PEG” on one side and “250” on the other.

The 250 mg strength is film-coated and is available in bottles of 100 (NDC 0884-0773-04).


Gris-PEG (griseofulvin ultramicrosize) is indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete’s foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber’s itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of 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, 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 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.


Accurate diagnosis of 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.

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 ® 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 7.3 mg per kg 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: 16-27 kg: 125 mg to 187.5 mg daily over 27 kg: 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 organism is eradicated.