ULTRAMICROSIZE GRISEOFULVIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sigmapharm Laboratories, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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

Product summary:

Ultramicrosize Griseofulvin Tablets, USP 125 mg are white to off-white, round, standard concave, bisected tablets, debossed 'Σ' and '13' on either side of the bisection and plain on the other side. The 125 mg strength is available in bottles of 30’s (NDC 42794-013-08). Ultramicrosize Griseofulvin Tablets, USP 250 mg are white to off-white, round, standard concave, bisected tablets, debossed 'Σ' and '14' on either side of the bisection and plain on the other side. The 250 mg strength is available in bottles of 30’s (NDC 42794-013-08). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. Rx ONLY Sigmapharm Laboratories, LLC Bensalem, PA 19020 OS014A-02 REV.0321

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ULTRAMICROSIZE GRISEOFULVIN- ULTRAMICROSIZE GRISEOFULVIN TABLET
SIGMAPHARM LABORATORIES, LLC
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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:
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 ultramicrosize griseofulvin tablet contains ultramicrosize
griseofulvin 125 mg or
250 mg and the following inactive ingredients: lactose monohydrate,
corn starch,
microcrystalline cellulose, povidone, polyethylene glycol 400,
poloxamer 188, anhydrous
lactose, silicon dioxide, crospovidone and magnesium stearate.
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.
Susceptibilitv Testing
For specific information regarding susceptibility test interpretive
criteria and associated
test methods and quality control standards
recognized by FDA for this drug, please see: https://www.fda.gov/STIC.
_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.
17
17
6
approximately one and one-half times that of the conventional
microsize griseofulvin.
This factor permits the oral intake o