CNL8- ciclopirox solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

CICLOPIROX (UNII: 19W019ZDRJ) (CICLOPIROX - UNII:19W019ZDRJ)

Dostupné s:

Innocutis Holdings LLC

INN (Mezinárodní Name):

CICLOPIROX

Složení:

CICLOPIROX 2.28 g in 1 mL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) CNL8 (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 Tricho-phyto 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.

Přehled produktů:

CNL8 nail kit (ciclopirox topical solution, 8%), Swabplus nail lacquer remover, emery board – which contains 3 - 5 ml bottles of CNL8 (ciclopirox topical solution, 8%) nail lacquer (glass bottles with screw caps which are fitted with brushes), 25 - 0.15 ml nail lacquer remover swabs and 1 emery board (NDC 68712-027-01). CNL8 (ciclopirox topical solution, 8%) nail lacquer, single count 5 ml bottle (NDC 68712-027-03). Protect from light (e.g., store the bottle in the carton after every use). CNL8 (ciclopirox topical solution, 8%) nail lacquer should be stored at room temperature between 59° and 86° F (15° and 30° C).

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CNL8 - CICLOPIROX SOLUTION
INNOCUTIS HOLDINGS LLC
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CNL8 (CICLOPIROX TOPICAL SOLUTION 8%)NAIL LACQUER
DESCRIPTION
CNL8 (ciclopirox topical solution, 8%) nail lacquer.
For use on fingernails and toenails and immediately adjacent skin
only.
Not for use in eyes.
CNL8 (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 CNL8 (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.
CNL8 (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 C12H17NO2 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.
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 t