GRISEOFULVIN- griseofulvin tablet, film coated

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Griseofulvin (UNII: 32HRV3E3D5) (Griseofulvin - UNII:32HRV3E3D5)

Available from:

Oceanside Pharmaceuticals

INN (International Name):

Griseofulvin

Composition:

Griseofulvin 250 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 infections, ca

Product summary:

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 68682-519-01). 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 68682-520-01). Store Griseofulvin ultramicrosize tablets at controlled room temperature 15° to 30°C (59° to 86°F) in tight, light-resistant containers.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

GRISEOFULVIN- GRISEOFULVIN TABLET, FILM COATED
OCEANSIDE PHARMACEUTICALS
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GRISEOFULVIN
ULTRAMICROSIZE
TABLETS, USP 125 MG; 250 MG
RX ONLY
DESCRIPTION
Griseofulvin Ultramicrosize 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’ß-methylspiro[benzofuran-
2(3H), 1’ – [2] cyclohexene]-3,4’-dione. Its structural formula
is:
C
H ClO M.W. 352.77
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 Griseofulvin ultramicrosize 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.
17
17
6
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 g