Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
CICLOPIROX (UNII: 19W019ZDRJ) (CICLOPIROX - UNII:19W019ZDRJ)
Cosette 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%, (Nail Lacquer), 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%, (Nail Lacquer),
Ciclopirox Topical Solution, 8%, (Nail Lacquer), is supplied in 3.3 mL (NDC 0713-0317-87) and 6.6 mL (NDC 0713-0317-88) glass bottles with screw caps which are fitted with brushes. Protect from light (e.g., store the bottle in the carton after every use.) Ciclopirox Topical Solution, 8%, (Nail Lacquer), should be stored at room temperature between 59° and 86° F (15° and 30° C). CAUTION: Flammable. Keep away from heat and flame.
Abbreviated New Drug Application
CICLOPIROX- CICLOPIROX SOLUTION COSETTE PHARMACEUTICALS, INC. ---------- 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%, (Nail Lacquer) 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%, (Nail Lacquer), contains 80 mg ciclopirox in a solution base consisting of ethyl acetate, NF; isopropyl alcohol, USP; and butyl monoester of poly[methylvinyl ether/maleic acid] in isopropyl alcohol. Ethyl acetate and isopropyl alcohol are solvents that vaporize after application. Ciclopirox Topical Solution, 8%, (Nail Lacquer), 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 molecular 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 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+3 or Al+3) 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. 12 17 2 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.(1-2) As a consequence, a broad range of MIC values, 1-20 mcg/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 Pročitajte cijeli dokument