GRIS-PEG- griseofulvin tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

State of Florida DOH Central Pharmacy

INN (Διεθνής Όνομα):

GRISEOFULVIN

Σύνθεση:

GRISEOFULVIN 250 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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

Περίληψη προϊόντος:

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:

Καθεστώς αδειοδότησης:

New Drug Application

Αρχείο Π.Χ.Π.

GRIS-PEG - GRISEOFULVIN TABLET, FILM COATED
STATE OF FLORIDA DOH CENTRAL PHARMACY
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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