País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
GRISEOFULVIN (UNII: 32HRV3E3D5) (GRISEOFULVIN - UNII:32HRV3E3D5)
Sandoz Inc
GRISEOFULVIN
GRISEOFULVIN 250 mg
ORAL
PRESCRIPTION DRUG
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) H
Griseofulvin tablets, USP (microsize) are available as follows: 250 mg, white to off-white round, flat, beveled edge, scored tablets engraved with 'I27' on one side and score on the other. 500 mg, white to off-white round, flat, beveled edge, scored tablets engraved with 'I26' on one side and score on the other. Dispense griseofulvin tablets, USP (microsize) in a tight container as defined in the USP. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by USV Private Limited, Mahatma Gandhi Udyog Nagar, Dabhel, Daman 396210, India for Sandoz Inc., Princeton, NJ 08540 Rev. December 2016
Abbreviated New Drug Application
GRISEOFULVIN- GRISEOFULVIN TABLET SANDOZ INC ---------- GRISEOFULVIN TABLETS, USP (MICROSIZE) 250 MG AND 500 MG PRESCRIBING INFORMATION DESCRIPTION Griseofulvin tablets, USP (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 tablets, USP (microsize) are available as follows: 250 mg, white to off-white round, flat, beveled edge, scored tablets engraved with 'I27' on one side and score on the other. 500 mg, white to off-white round, flat, beveled edge, scored tablets engraved with 'I26' on one side and score on the other. Each tablet contains 250 mg or 500 mg of griseofulvin microsize, and also contains calcium stearate, colloidal silicon dioxide, corn starch, crospovidone, dibasic calcium phosphate, and sodium starch glycolate. 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 concentratio Llegiu el document complet