Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)
Encube Ethicals Private Limited
TOPICAL
PRESCRIPTION DRUG
Ketoconazole Cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum , T. mentagrophytes and Epidermophyton floccosum ; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare) ; and in the treatment of cutaneous candidiasis caused by Candida spp . and in the treatment of seborrheic dermatitis. Ketoconazole Cream, 2% is contraindicated in persons who have shown hypersensitivity to the active or excipient ingredients of this formulation.
Ketoconazole Cream, 2% is supplied in 15, 30, and 60 gram tubes. 15 g tube (21922- 025-04) 30 g tube (21922- 025-05) 60 g tube (21922- 025-07) STORAGE Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Mfg Lic No. : 361 Manufactured by : Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa - 403 404, India. Distributed by: Encube Ethicals, Inc. 200 Meredith Avenue, Suite 101A Durham, NC 27713 USA Rev: 03 May 2021
Abbreviated New Drug Application
KETOCONAZOLE- KETOCONAZOLE CREAM, 2% CREAM ENCUBE ETHICALS PRIVATE LIMITED ---------- KETOCONAZOLE CREAM RX ONLY DESCRIPTION Ketoconazole Cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%. Each gram, for topical administration, contains ketoconazole 20 mg and is formulated in an aqueous cream vehicle consisting of propylene glycol, purified water, cetyl alcohol, stearyl alcohol, isopropyl myristate, sorbitan monostearate, polysorbate 60, polysorbate 80, and sodium sulfite, anhydrous: Ketoconazole is cis-1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3- dioxolan-4-yl]methoxy]phenyl] piperazine and has the following structural formula: M. Formula: C H Cl N O M.W.: 531.44 CLINICAL PHARMACOLOGY When Ketoconazole Cream, 2% was applied dermally to intact or abraded skin of Beagle dogs for 28 consecutive days at a dose of 80 mg, there were no detectable plasma levels using an assay method having a lower detection limit of 2 ng/ml. After a single topical application to the chest, back and arms of normal volunteers, systemic absorption of ketoconazole was not detected at the 5 ng/ml level in blood over a 72-hour period. Two dermal irritancy studies, a human sensitization test, a phototoxicity study and a photoallergy study conducted in 38 male and 62 female volunteers showed no contact sensitization of the delayed hypersensitivity type, no irritation, no phototoxicity and no photoallergenic potential due to Ketoconazole Cream, 2%. MICROBIOLOGY: Ketoconazole is a broad spectrum synthetic antifungal agent which inhibits the in vitro growth of the following common dermatophytes and yeasts by altering the permeability 26 28 2 4 4 of the cell membrane: dermatophytes: _Trichophyton rubrum, T. mentagrophytes, T._ _tonsurans, Microsporum canis, M. audouini, M. gypseum and Epidermophyton_ _floccosum_; _yeasts: Candida albicans , Malassezia ovale (Pityrosporum ovale)_ and _C._ _tropicalis_; and the organism responsible for tinea versicolor, _Malassezia furfur_ _(Pityrosporum orbi Perskaitykite visą dokumentą