GRIS-PEG- griseofulvin tablet, film coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

griseofulvin (UNII: 32HRV3E3D5) (griseofulvin - UNII:32HRV3E3D5)

Disponible des:

Pedinol Pharmacal, Inc.

Designació comuna internacional (DCI):

griseofulvin

Composición:

griseofulvin 250 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 inf

Resumen del producto:

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).

Estat d'Autorització:

New Drug Application

Fitxa tècnica

GRIS-PEG- GRISEOFULVIN TABLET, FILM COATED
PEDINOL PHARMACAL, INC.
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GRIS-PEG
(GRISEOFULVIN ULTRAMICROSIZE)
TABLETS, USP 125 MG; 250 MG
RX ONLY
DESCRIPTION
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:
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.
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.
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H ClO M.W. 352.77
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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