Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
GRISEOFULVIN (UNII: 32HRV3E3D5) (GRISEOFULVIN - UNII:32HRV3E3D5)
Chartwell RX, LLC.
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) Hist
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
Abbreviated New Drug Application
GRISEOFULVIN MICROSIZE- GRISEOFULVIN TABLET CHARTWELL RX, LLC. ---------- 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 Lire le document complet