Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
GRISEOFULVIN (UNII: 32HRV3E3D5) (GRISEOFULVIN - UNII:32HRV3E3D5)
State of Florida DOH Central Pharmacy
GRISEOFULVIN
GRISEOFULVIN 250 mg
ORAL
PRESCRIPTION DRUG
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: bacter
Gris-PEG® (griseofulvin ultramicrosize) Tablets, 125 mg, white scored, elliptical-shaped, embossed "Gris-PEG" on one side and "125" on the other. Gris-PEG® (griseofulvin ultramicrosize) Tablets, 250 mg, white scored, capsule-shaped, embossed "Gris-PEG" on one side and "250" on the other. Both strengths are film-coated. They are supplied by State of Florida DOH Central Pharmacy as follows:
New Drug Application
GRIS-PEG - GRISEOFULVIN TABLET, FILM COATED STATE OF FLORIDA DOH CENTRAL PHARMACY ---------- GRIS-PEG (GRISEOFULVIN ULTRAMICROSIZE) TABLETS, USP 125 MG; 250 MG DESCRIPTION Gris-PEG Tablets contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of _Penicillium_. Each Gris-PEG tablet contains: _Active Ingredient:_ griseofulvin ultramicrosize .... 125 mg _Inactive Ingredients:_ colloidal silicon dioxide, lactose, magnesium stearate, methylcellulose, methylparaben, polyethylene glycol 400 and 8000, polyvinylpyrrolidone, and titanium dioxide. or _Active Ingredient:_ griseofulvin ultramicrosize .... 250 mg _Inactive Ingredients:_ colloidal silicon dioxide, magnesium stearate, methylcellulose, methylparaben, polyethylene glycol 400 and 8000, povidone, sodium lauryl sulfate, and titanium dioxide. ACTION 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 intake of two-thirds as much ultramicrocrystalline griseofulvin as the microsize form. However, there is currently no evidence that this lower dose confers any significant clinical differences with regard to safety and/or efficacy. In a bioequivalence study conducted in healthy volunteers (N=24) in the fasted state, 250 mg ultramicrocrystalline griseofulvin tablets were compared with 250 mg ultramicrocrystalline griseofulvin tablets that were physically altered (crushed) and administered with applesauce. The 250 mg ultramicrocrystalline griseofulvin ta Læs hele dokumentet