Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
GRISEOFULVIN (UNII: 32HRV3E3D5) (GRISEOFULVIN - UNII:32HRV3E3D5)
Amneal Pharmaceuticals of New York LLC
GRISEOFULVIN
GRISEOFULVIN 125 mg
ORAL
PRESCRIPTION DRUG
Ultramicrosize griseofulvin tablets 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 in
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. They are available as follows: Bottles of 100: NDC 0115-1724-01 Bottles of 500: NDC 0115-1724-02 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. They are available as follows: Bottles of 100: NDC 0115-1725-01 Bottles of 1000: NDC 0115-1725-03
Abbreviated New Drug Application
ULTRAMICROSIZE GRISEOFULVIN- ULTRAMICROSIZE GRISEOFULVIN TABLETS TABLET, COATED AMNEAL PHARMACEUTICALS OF NEW YORK LLC ---------- ULTRAMICROSIZE GRISEOFULVIN TABLETS, USP (125 MG AND 250 MG) RX ONLY DESCRIPTION Ultramicrosize griseofulvin tablets, USP 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, USP 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. CLINICAL PHARMACOLOGY MICROBIOLOGY Griseofulvin is fungistatic with _in vitro _activity against various species of _Microsporum,_ _Epidermophyton _and _Trichophyton_. It has no effect on bacteria or other genera of fungi. PHARMACOKINETICS Following oral administration, griseofulvin is deposited in the keratin precursor cells and has a greater affinity for diseased tissue. The drug is tightly bound to the new keratin which becomes highly resistant to fungal invasions. The efficiency of gastrointestinal absorption of ultramicrocrystalline griseofulvin is approximately one and one-half times that of the conventional microsize griseofulvin. This factor permits the oral intak Läs hela dokumentet