ULTRAMICROSIZE GRISEOFULVIN- ultramicrosize griseofulvin tablets tablet, coated

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

GRISEOFULVIN (UNII: 32HRV3E3D5) (GRISEOFULVIN - UNII:32HRV3E3D5)

Disponible des:

CorePharma, LLC

Designació comuna internacional (DCI):

GRISEOFULVIN

Composición:

GRISEOFULVIN 125 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 in

Resumen del producto:

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).

Estat d'Autorització:

Abbreviated New Drug Application

Fitxa tècnica

ULTRAMICROSIZE GRISEOFULVIN- ULTRAMICROSIZE GRISEOFULVIN TABLETS
TABLET, COATED
COREPHARMA, LLC
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ULTRAMICROSIZE GRISEOFULVIN TABLETS, USP
125 MG; 250 MG
RX ONLY
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.
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 intake of
two-thirds as much ultramicroc