国: アメリカ合衆国
言語: 英語
ソース: NLM (National Library of Medicine)
GRISEOFULVIN (UNII: 32HRV3E3D5) (GRISEOFULVIN - UNII:32HRV3E3D5)
Actavis Pharma, Inc.
GRISEOFULVIN
GRISEOFULVIN 125 mg in 5 mL
ORAL
PRESCRIPTION DRUG
Griseofulvin oral suspension, USP 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
Griseofulvin oral suspension, USP (microsize), 125 mg per 5 mL is an orange-vanilla flavored suspension available in bottles of 4 fl oz (120 mL) NDC 0472-0013-04. 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]. Manufactured For: Teva Pharmaceuticals Parsippany, NJ 07054 Rev. C 9/2023
Abbreviated New Drug Application
GRISEOFULVIN- GRISEOFULVIN SUSPENSION ACTAVIS PHARMA, INC. ---------- GRISEOFULVIN ORAL SUSPENSION, USP (MICROSIZE), 125 MG/5 ML RX ONLY DESCRIPTION Griseofulvin microsize contains griseofulvin microsize for oral administration. The active ingredient, griseofulvin, USP is a fungistatic 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]cyclohexane]-3-4’-dione. Its structural formula is: C H ClO M.W. 352.77 Griseofulvin, USP 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 an orange colored suspension. Each 5 mL of griseofulvin oral suspension, USP contains 125 mg of griseofulvin microsize and also contains alcohol 0.2%, artificial orange vanilla flavor, docusate sodium, FD&C Red No. 40, FD&C Yellow No. 6, magnesium aluminum silicate, menthol, methylparaben, propylene glycol, propylparaben, saccharin sodium, simethicone emulsion, sodium alginate, sucrose, and purified water. CLINICAL PHARMACOLOGY 17 17 6 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/kg of griseofulvin microsize given with milk resulted in mean peak serum concentrations approximately four-fold greater than the sam 完全なドキュメントを読む