Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
ciclopirox (UNII: 19W019ZDRJ) (ciclopirox - UNII:19W019ZDRJ)
Bausch Health US LLC
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.) PENLAC® Nail Lacquer (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 PENLAC® Nail Lacquer (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 US. In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with c
PENLAC® Nail Lacquer (ciclopirox) Topical Solution, 8%, is supplied in 6.6 mL (NDC 0187-5180-06) glass bottles with screw caps which are fitted with brushes. Protect from light (e.g., store the bottle in the carton after every use). PENLAC® Nail Lacquer (ciclopirox) Topical Solution, 8%, should be stored at room temperature between 59° and 86° F (15° and 30° C). CAUTION: Flammable. Keep away from heat and flame. Rx only Manufactured for: Valeant Pharmaceuticals North America LLC Bridgewater, NJ 08807 USA by: Sanofi-Aventis Deutschland GmbH 65926 Frankfurt am Main, Germany References: Penlac is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates. Any other product/brand names are trademarks of their respective owners. ©2016 Valeant Pharmaceuticals North America LLC Rev. 06/2016 9542701
New Drug Application
PENLAC- CICLOPIROX SOLUTION BAUSCH HEALTH US LLC ---------- PENLAC NAIL LACQUER (CICLOPIROX) TOPICAL SOLUTION, 8% FOR USE ON FINGERNAILS AND TOENAILS AND IMMEDIATELY ADJACENT SKIN ONLY NOT FOR USE IN EYES DESCRIPTION PENLAC Nail Lacquer (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 PENLAC Nail Lacquer (ciclopirox) Topical Solution, 8%, 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. PENLAC Nail Lacquer (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 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 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 ciclopirox. One Läs hela dokumentet