Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
CICLOPIROX OLAMINE (UNII: 50MD4SB4AP) (CICLOPIROX - UNII:19W019ZDRJ)
Cosette Pharmaceuticals, Inc.
Ciclopirox Olamine
Ciclopirox 7.7 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Ciclopirox Olamine Cream USP, 0.77% 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. Safety and effectiveness in pediatric patients below the age of 10 years have not been established.
Ciclopirox Olamine Cream USP, 0.77% is supplied in: 15-g tubes (NDC 0713-0638-15) 30-g tubes (NDC 0713-0638-31) 90-g tubes (NDC 0713-0638-18) Store at 20-25°C (68-77°F). [See USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 8-0638CPLNC2 VC7640 Rev. 06/2022
Abbreviated New Drug Application
CICLOPIROX OLAMINE- CICLOPIROX OLAMINE CREAM COSETTE PHARMACEUTICALS, INC. ---------- CICLOPIROX OLAMINE CREAM USP, 0.77% (CICLOPIROX CREAM) FOR DERMATOLOGIC USE ONLY. NOT FOR USE IN EYES. DESCRIPTION Ciclopirox Olamine Cream USP, 0.77% 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, mineral oil USP, stearyl alcohol NF, cetyl alcohol NF, cocamide DEA, 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: CLINICAL PHARMACOLOGY MECHANISM OF ACTION Ciclopirox is a hydroxypyridone antifungal agent that acts by chelation of polyvalent cations (Fe or A1 ), resulting in the inhibition of the metal-dependent enzymes that are responsible for the degradation of peroxides within the fungal cell. PHARMACOKINETICS 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 3+ 3+ 2 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 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 showed that ciclopirox pe Lees het volledige document