Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
CICLOPIROX (UNII: 19W019ZDRJ) (CICLOPIROX - UNII:19W019ZDRJ)
Bryant Ranch Prepack
TOPICAL
PRESCRIPTION DRUG
(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGEsection 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. - No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of 8% ciclopirox topical solution and systemic antifungal agents for onychomycosis, is not recommended. - Ciclopirox Topical Solution, 8% should be used only under medical supervision as desc
Ciclopirox Topical Solution, 8% is available as follows: 6.6 mL glass bottle with a screw cap fitted with a brush (NDC: 63629-8623-1) 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 BRYANT RANCH PREPACK ---------- 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_study was conducted e Baca dokumen lengkapnya