GRISEOFULVIN MICROSIZE- griseofulvin tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Chartwell RX, LLC.

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Griseofulvin tablets, USP are 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 tablets, USP are not effective in the following: Bacterial infections Candidiasis (Moniliasis) Hist

Product summary:

Griseofulvin Tablets, USP (microsize) 500 mg: are supplied as white to off white, round, scored tablets, debossed with ‘CE’ over ‘5’ on one side and a functional score on the other side. They are available as follows:  Bottles of 30 tablets        NDC 62135-496-30. Bottles of 100 tablets        NDC 62135-496-01. Store at 20°-25°C (68°-77°F). [see USP Controlled Room Temperature]. Manufactured by:       Chartwell Pharmaceuticals, LLC.                   Congers, NY 10920 Manufactured for:       Chartwell RX, LLC.                   Congers, NY 10920 Made in USA L70376        Rev: 11/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GRISEOFULVIN MICROSIZE- GRISEOFULVIN TABLET
CHARTWELL RX, LLC.
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GRISEOFULVIN TABLETS MICROSIZE
GRISEOFULVIN TABLETS, USP (MICROSIZE)
500 MG
RX ONLY
DESCRIPTION
Griseofulvin tablets, USP (microsize) contain 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:
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 tablet contains 500 mg of microsized griseofulvin.
The inactive ingredients for griseofulvin tablets 500 mg, include:
magnesium stearate,
poloxamer 188, potato starch, and colloidal silicon dioxide.
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 the 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 microsize given with milk resulted in mean peak serum
concentrations
approximately four-fold greater than the same griseofulvin dose given
alone (1.29
mcg/mL versus 0.34 mcg/mL, respectively). Also, the area under the
curve value was
ten-fold larger when 10 mg/kg griseofulvin and milk were administered
simultaneously as
compared to the same dosage given to fasting patients. In ad