País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
CICLOPIROX OLAMINE (UNII: 50MD4SB4AP) (CICLOPIROX - UNII:19W019ZDRJ)
E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc.
CICLOPIROX OLAMINE
CICLOPIROX 7.7 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
Ciclopirox 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 Cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
Ciclopirox Cream 0.77% (Ciclopirox Olamine Cream USP) is supplied in: NDC 0168-0313-15 15 gram tube NDC 0168-0313-30 30 gram tube NDC 0168-0313-90 90 gram tube Store at 20°-25°C (68°-77°F). [see USP Controlled Room Temperature] E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2313B R11/11 #99
Abbreviated New Drug Application
CICLOPIROX OLAMINE- CICLOPIROX OLAMINE CREAM E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC. ---------- CICLOPIROX CREAM 0.77% (CICLOPIROX OLAMINE CREAM USP) RX ONLY FOR DERMATOLOGIC USE ONLY NOT FOR OPHTHALMIC USE DESCRIPTION Ciclopirox Cream 0.77% is for topical use. Each gram of Ciclopirox cream 0.77% contains 7.70 mg of Ciclopirox (as Ciclopirox Olamine) in a water miscible vanishing cream base consisting of purified water USP, cetyl alcohol NF, mineral oil USP, octyldodecanol NF, stearyl alcohol NF, cocamide DEA, polysorbate 60 NF, myristyl alcohol, sorbitan monostearate NF, lactic acid USP, and benzyl alcohol NF (1%) as preservative. Ciclopirox 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 Cream 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, Epidermophyton 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 cream 0.77% 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. Autora Leer el documento completo