Griseofulvin Ultramicrosize Tablets, USP 125 mg; 250 mg Rx only

Griseofulvin Ultramicrosize 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’ß-methylspiro[benzofuran-2(3H), 1’ – [2] cyclohexene]-3,4’-dione. Its structural formula is:

C₁₇H₁₇ClO₆ 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 Griseofulvin ultramicrosize 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.

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.

Two cases of conjoined twins have been reported since 1977 in patients taking griseofulvin during the first trimester of pregnancy. Griseofulvin should not be prescribed to pregnant patients. If the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

This drug is contraindicated in patients with porphyria or hepatocellular failure and in individuals with a history of hypersensitivity to griseofulvin.

Patients on prolonged therapy with any potent medication should be under close observation. Periodic monitoring of organ system function, including renal, hepatic and hematopoietic, should be done. Since griseofulvin is derived from species of Penicillium, 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. Lupus erythematosus or lupus-like syndromes have been reported in patients receiving griseofulvin. Griseofulvin decreases the activity of warfarin-type anticoagulants so that patients receiving these drugs concomitantly may require dosage adjustment of the anticoagulant during and after griseofulvin therapy. Barbiturates usually depress griseofulvin activity and concomitant administration may require a dosage adjustment of the antifungal agent. There have been reports in the literature of possible interactions between griseofulvin and oral contraceptives. The effect of alcohol may be potentiated by griseofulvin, producing such effects as tachycardia and flush.

There have been post-marketing reports of severe skin and hepatic adverse events associated with griseofulvin use (see WARNINGS section).

When adverse reactions occur, they are most commonly of the hypersensitivity type such as skin rashes, urticaria, erythema multiforme-like drug reactions, and rarely, angioneurotic edema, and may necessitate withdrawal of therapy and appropriate countermeasures. Paresthesia of the hands and feet have been reported 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.

To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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.

Griseofulvin ultramicrosize tablets may be swallowed whole or crushed and sprinkled onto 1 tablespoonful of applesauce and swallowed immediately without chewing.

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 68682-519-01).

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 68682-520-01).

Manufactured for:

Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

By:

Valeant Pharmaceuticals International, Inc.

Laval, Quebec, Canada, H7L 4A8

Rev. 07/2016

9470403

20000983D

NDC 68682-520-01

Rx only

Griseofulvin Ultramicrosize

Tablets, USP

250 mg

100 Tablets

OCEANSIDE®

PHARMACEUTICALS

NDC 68682-519-01

Rx only

Griseofulvin Ultramicrosize

Tablets, USP

125 mg

100 Tablets

OCEANSIDE®

PHARMACEUTICALS