Country: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
CICLOPIROX (UNII: 19W019ZDRJ) (CICLOPIROX - UNII:19W019ZDRJ)
Preferred Pharmaceuticals, Inc.
CICLOPIROX
CICLOPIROX 80 mg in 1 mL
TOPICAL
PRESCRIPTION DRUG
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclopirox Topical Solution, 8% as a component of a comprehensive management program, is indicated as topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, due to Trichophyton rubrum . The comprehensive management program includes removal of the unattached, infected nails as frequently as monthly, by a health care professional who has special competence in the diagnosis and treatment of nail disorders, including minor nail procedures. The results of use of ciclopirox topical solution, 8% in treatment of onychomycosis of the toenail without lunula involvement were obtained from two double-blind, placebo-controlled studies conducted in the United States. In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8% in conjun
Ciclopirox Topical Solution, 8% is available as follows: 6.6 mL glass bottle with a screw cap fitted with a brush NDC 68788-6797-6 Protect from light (store bottle in the carton after every use). Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. CAUTION: Flammable. Keep away from heat and flame.
Abbreviated New Drug Application
CICLOPIROX- CICLOPIROX SOLUTION PREFERRED PHARMACEUTICALS, INC. ---------- CICLOPIROX TOPICAL SOLUTION, 8% CICLOPIROX TOPICAL SOLUTION, 8% NAIL LACQUER RX ONLY FOR USE ON FINGERNAILS AND TOENAILS AND IMMEDIATELY ADJACENT SKIN ONLY. NOT FOR USE IN EYES. DESCRIPTION Ciclopirox Topical Solution, 8% contains a synthetic antifungal agent, ciclopirox. It is intended for topical use on fingernails and toenails and immediately adjacent skin. Each gram of Ciclopirox Topical Solution, 8% contains 80 mg ciclopirox in a solution base consisting of butyl ester of poly [vinylmethylether/maleic acid copolymer] in isopropyl alcohol, ethyl acetate, and isopropyl alcohol. Ethyl acetate and isopropyl alcohol are solvents that vaporize after application. Ciclopirox Topical Solution, 8% is a clear, colorless to slightly yellowish solution. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, with the empirical formula C H NO and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is: CLINICAL PHARMACOLOGY MICROBIOLOGY 12 17 2 MECHANISM OF ACTION - The mechanism of action of ciclopirox has been investigated using various _in vitro _and _in vivo _infection models. One _in vitro _study suggested that ciclopirox 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. The clinical significance of this observation is not known. ACTIVITY _IN VITRO _AND _EX VIVO _- _In vitro _methodologies employing various broth or solid media with and without additional nutrients have been utilized to determine ciclopirox minimum inhibitory concentration (MIC) values for the dermatophytic molds. As a consequence, a broad range of MIC values, 1-20 ug/mL, were obtained for _Trichophyton_ _rubrum _and _Trichophyton mentagrophytes _species. Correlation between _in vitro _MIC results and clinical outcome has yet to be established for ciclopirox. One _ex vivo Aqra d-dokument sħiħ