Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)
REMEDYREPACK INC.
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 . 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 NDC: 70518-3367-00 PACKAGING: 1 in 1 CARTON, 30 g in 1 TUBE TYPE 0 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762
Abbreviated New Drug Application
KETOCONAZOLE- KETOCONAZOLE CREAM REMEDYREPACK INC. ---------- 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-(1 _H_-imidazol-1-ylmethyl)- 1,3-dioxolan-4-yl]methoxy]phenyl]piperazine and has the following structural 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%. 26 28 2 4 4 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 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 orbiculare)_. Only thos Đọc toàn bộ tài liệu