ULTRAMICROSIZE GRISEOFULVIN- ultramicrosize griseofulvin tablets tablet, coated

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Amneal Pharmaceuticals of New York LLC

INN (Alþjóðlegt nafn):

GRISEOFULVIN

Samsetning:

GRISEOFULVIN 125 mg

Stjórnsýsluleið:

ORAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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

Vörulýsing:

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

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

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