GRISEOFULVIN suspension

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cosette Pharmaceuticals, Inc.

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 Coccidioidomycosis Candidiasis (Moniliasis) North American Blastomycosis Histoplasmosis Cryptococcosis (Torulosis) Actinomycosis Tinea versicolor Sporotrichosis Nocardiosis Chromoblastomycosis The use of this drug is not justified in minor or trivial dermatophyte infections which will respond to topical agents alone. Griseofulvin is contraindicated in patients with porphyria or hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin. Griseofulvin may cause fetal harm when administered to a pregnant woman. Two published cases of conjoined twins have been reported in patients taking griseofulvin during the first trimester of pregnancy, therefore, griseofulvin is contraindicated in women who are or may become pregnant during treatment. Women taking estrogen-containing oral contraceptives may be at increased risk of becoming pregnant while on griseofulvin (see also PRECAUTIONS, Drug Interactions ). If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Although no direct causal relationship has been established, spontaneous abortion has been reported rarely coincident with the use of griseofulvin. Note: The Maximum Recommended Human Dose (MRHD) was set at 500 mg/day for the multiple of human exposure calculations performed in this label. If higher doses than 500 mg/day were used clinically, then the multiple of human exposure would be correspondingly reduced for that dose. For example, if a 1000 mg/day dose was administered to an individual, then the multiple of human exposure would be reduced by a factor of 2. Griseofulvin has been shown to be embryotoxic and teratogenic in pregnant rats when given at a daily oral dose of 250 mg/kg/day [4X the Maximum Recommended Human Dose (MRHD) based on Body Surface Area (BSA)]. Griseofulvin also has been shown to be embryotoxic and teratogenic in pregnant cats treated weekly with griseofulvin at doses of 500 to 1000 mg/week. There are reports of teratogenicity in a Golden Retriever when doses of 750 mg/day [1.2X the MRHD based on BSA] were administered for four weeks prior to and throughout the pregnancy, and in a study in which beagles were administered 35 mg/kg/day [1.9X the MRHD based on BSA] for intervals from one week up to the entire gestation period. Teratogenicity was also seen in mice when griseofulvin was administered in doses equivalent to 5g/kg/day [40X the MRHD based on BSA] for 2 consecutive days at various stages of the pregnancy.

Product summary:

Griseofulvin Oral Suspension, USP is orange in color with orange flavor. Griseofulvin Oral Suspension, USP 125 mg per 5 mL in bottles of 4 fl oz (118 mL) [NDC 0713-0850-04]. Dispense Griseofulvin Oral Suspension, USP in a tight, light-resistant container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

GRISEOFULVIN- GRISEOFULVIN SUSPENSION
COSETTE PHARMACEUTICALS, INC.
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GRISEOFULVIN ORAL SUSPENSION, USP
MICROSIZE
125 MG/5 ML
RX ONLY
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:
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 Oral Suspension, USP is orange in color with orange
flavor. Each 5 mL of
Griseofulvin Oral Suspension, USP contains 125 mg of griseofulvin
microsize and also
contains alcohol 0.2%, docusate sodium, FD&C Red No. 40, FD&C Yellow
No. 6,
magnesium aluminum silicate, menthol, methylparaben, orange flavor,
propylene glycol,
propylparaben, purified water, saccharin sodium, simethicone emulsion
(silicon dioxide,
carboxymethylcellulose sodium, and sorbic acid), sodium alginate, and
sucrose.
Griseofulvin Oral Suspension, USP may contain dibasic sodium phosphate
or potassium
phosphate monobasic for pH adjustment.
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 2.0
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/