Drug Catalog - Product Detail
GRISEOFULVIN ULTRAMICROSIZE TAB 125 MG 100 CT
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 64720-0295-10 | AMNEAL PHARMACEUTICALS | 100 | 125MG | TABLET |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Ultramicrosize Griseofulvin 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: 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 ultramicrosize Griseofulvin tablet contains: Active Ingredient: Griseofulvin ultramicrosize ..........................125 mg Inactive Ingredients: Colloidal Silicon Dioxide, Magnesium Stearate, Polyethylene Glycol 3350, Polyethylene Glycol 6000, Polyethylene Glycol 8000, Polyvinyl Alcohol, Sodium Lauryl Sulfate, Talc, Titanium Dioxide. OR Active Ingredient: Griseofulvin ultramicrosize ..........................250 mg Inactive Ingredients: Colloidal Silicon Dioxide, Magnesium Stearate, Polyethylene Glycol 3350, Polyethylene Glycol 6000, Polyethylene Glycol 8000, Polyvinyl Alcohol, Sodium Lauryl Sulfate, Talc, Titanium Dioxide. Chemical Structure
How Supplied
HOW SUPPLIED Ultramicrosize Griseofulvin Tablets USP, 125 mg, are supplied as white to off-white oval coated tablets debossed “C” on the left side of the score line and “p” on the right side of the score line on one side and “295”on the other side. The 125 mg strength is film-coated, functionally scored and is available in bottles of 100 (NDC 64720-295-10) and 500 (NDC 64720-295-50). Ultramicrosize Griseofulvin Tablets USP, 250 mg, are supplied as white to off-white oval coated tablets debossed “C” on the left side of the score line and “p” on the right side of the score line on one side and “296”on the other side. The 250 mg strength is film-coated, functionally scored and is available in bottles of 100 (NDC 64720-296-10) and 1000 (NDC 64720-296-11).
Indications & Usage
INDICATIONS AND USAGE Ultramicrosize Griseofulvin Tablets, USP are 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION 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 should 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. Ultramicrosize Griseofulvin 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.