Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
CICLOPIROX OLAMINE (UNII: 50MD4SB4AP) (CICLOPIROX - UNII:19W019ZDRJ)
Padagis Israel Pharmaceuticals Ltd
CICLOPIROX OLAMINE
CICLOPIROX 7.7 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Ciclopirox olamine cream 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 is contraindicated in individuals who have shown hypersensitivity to any of its components.
Ciclopirox Olamine Cream USP, 0.77% is available as follows: 15 g tube (NDC 45802-138 -35) 30 g tube (NDC 45802-138 -11) 90 g tube (NDC 45802-138 -18)
Abbreviated New Drug Application
CICLOPIROX OLAMINE- CICLOPIROX OLAMINE CREAM PADAGIS ISRAEL PHARMACEUTICALS LTD ---------- CICLOPIROX OLAMINE CREAM USP, 0.77% FOR TOPICAL USE ONLY NOT FOR USE IN EYES RX ONLY DESCRIPTION Ciclopirox Olamine Cream USP, 0.77% is for topical use. Each gram of ciclopirox olamine cream contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible, vanishing cream base consisting of benzyl alcohol (1% as a preservative), cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate, and stearyl alcohol. Ciclopirox olamine cream 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 has a pH of 7. CLINICAL PHARMACOLOGY MECHANISM OF ACTION Ciclopirox is a hydroxypyridone antifungal agent that acts by chelation of polyvalent cations (Fe or Al ), 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 3+ 3+ 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 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 penetrates into the ha Olvassa el a teljes dokumentumot