Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
CICLOPIROX OLAMINE (UNII: 50MD4SB4AP) (CICLOPIROX - UNII:19W019ZDRJ)
Lake Erie Medical DBA Quality Care Products LLC
CICLOPIROX OLAMINE
CICLOPIROX OLAMINE 7.7 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Ciclopirox olamine cream, USP is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, and Microsporum canis; candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur. Ciclopirox olamine cream, USP is contraindicated in individuals who have shown hypersensitivity to any of its components.
Ciclopirox olamine cream, USP is supplied in 15 gram, 30 gram, and 90 gram tubes.
Abbreviated New Drug Application
CICLOPIROX OLAMINE - CICLOPIROX OLAMINE CREAM LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC ---------- CICLOPIROX OLAMINE 15G CREAM DESCRIPTION Ciclopirox olamine cream, USP is for topical use. Each gram of ciclopirox olamine cream, USP contains 7.70 mg of ciclopirox (as Ciclopirox Olamine) in a water miscible vanishing cream base consisting of Purified Water USP, Octyldodecanol NF, Light Mineral Oil NF, Stearyl Alcohol NF, Cetyl Alcohol NF, Polysorbate 60 NF, Myristyl Alcohol NF, Sorbitan Monostearate NF, Lactic Acid USP, and Benzyl Alcohol NF (1%) as preservative. Ciclopirox olamine cream, USP contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1_H_)-pyridone, 2- aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is_ _ Ciclopirox olamine cream, USP has a pH of 7. CLINICAL PHARMACOLOGY Ciclopirox is a broad-spectrum, antifungal agent that inhibits the growth of pathogenic dermatophytes, yeasts, and _Malassezia furfur_. Ciclopirox exhibits fungicidal activity _in vitro_ against isolates of _Trichophyton rubrum, Trichophyton mentagrophytes, Epidermorphyton floccosum, Microsporum canis, and_ _Candida albicans._ Pharmacokinetic studies in men with tagged ciclopirox solution in polyethylene glycol 400 showed an average of 1.3% absorption of the dose when it was applied topically to 750 cm on the back followed by occlusion for 6 hours. The biological half-life was 1.7 hours and excretion occurred via the kidney. Two days after application only 0.01% of the dose applied could be found in the urine. Fecal excretion was negligible. Penetration studies in human cadaverous skin from the back, with ciclopirox olamine cream, USP with tagged ciclopirox showed the presence of 0.8 to 1.6% of the dose in the stratum corneum 1.5 to 6 hours after application. The levels in the dermis were still 10 to 15 times above the minimum inhibitory concentrations. Autoradiographic studies with human cadaverous skin sh Прочетете целия документ