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:

Griseofulvin is indicated for the treatment of dermatophyte infections of the skin not adequately treated by topical therapy, hair and nails, namely: Tinea corporis Tinea pedis Tinea cruris Tinea barbae Tinea capitis Tinea unguium when caused by one or more of the following species of fungi: Epidermophyton floccosum Microsporum audouinii Microsporum canis Microsporum gypseum Trichophyton crateriform Trichophyton gallinae Trichophyton interdigitalis Trichophyton megnini Trichophyton mentagrophytes Trichophyton rubrum Trichophyton schoenleini Trichophyton sulphureum Trichophyton tonsurans Trichophyton verrucosum Note: Prior to therapy, a dermatophyte should be identified as responsible for the infection. Prior to initiating treatment, appropriate specimens for laboratory testing (KOH preparation, fungal culture, or nail biopsy) should be obtained to confirm the diagnosis. Griseofulvin is not effective in the following: Bacterial infections Candidiasis (Moniliasis) Histoplasmosis Actinomycosis Spo

Product summary:

Griseofulvin Tablets, USP (microsize) 500 mg are white, capsule shaped, bisected tablets, debossed with ‘Σ’ and ‘12’ on either side of the bisection and plain on the other side, and supplied in bottles of 30s (NDC 42794-012-08). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight container as defined in the USP. Rx ONLY Sigmapharm Laboratories, LLC Bensalem, PA 19020 OS012A-02 REV.0221

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GRISEOFULVIN- GRISEOFULVIN TABLET
SIGMAPHARM LABORATORIES, LLC
----------
GRISEOFULVIN TABLETS, USP (MICROSIZE) RX ONLY
PRESCRIBING INFORMATION
DESCRIPTION
Griseofulvin microsize contains griseofulvin microsize for oral
administration. The active
ingredient, griseofulvin, is a fungistatic antibiotic derived from a
species of _Penicillium_.
The chemical name of griseofulvin is
7-chloro-2’,4,6-trimethoxy-6’β-
methylspiro[benzofuran-2(3H),1’-[2]cyclohexane]-3-4’-dione. Its
structural formula is:
C
H
ClO
M.W = 352.77
Griseofulvin occurs as a white to creamy white, bitter tasting powder
which is very
slightly soluble in water and sparingly soluble in alcohol.
Griseofulvin microsize contains
particles of approximately 2 to 4 µm in diameter.
Griseofulvin Tablets, USP (microsize) 500 mg are white, capsule
shaped, bisected
tablets, debossed with ‘Σ’ and ‘12’ on either side of the
bisection and plain on the other
side. Each Griseofulvin Tablet, USP (microsize) 500 mg contains 500 mg
of griseofulvin
microsize, and also contains corn starch, povidone, polyethylene
glycol 400,
polyethylene glycol 8000, lactose monohydrate, crospovidone, silicon
dioxide and
magnesium stearate.
Meets USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
Griseofulvin absorption from the gastrointestinal tract varies
considerably among
individuals mainly because of insolubility of the drug in aqueous
media of the upper GI
tract. Drug absorption has been estimated to range between 27 and 72%.
After an oral
dose, griseofulvin is primarily absorbed from the duodenum with some
absorption
occurring from jejunum and ileum. The peak serum level in fasting
adults given 0.5 g of
griseofulvin microsize occurs at about four hours and ranges between
0.5 to 2 mcg/mL.
The serum level may be increased by giving the drug with a meal with a
high fat content.
In one study in pediatric patients 19 months to 11 years of age, 10
mg/kg of griseofulvin
17
17
6
microsize given with milk resulted in mean peak serum concentrations
approximately
four-fold greate