CICLOPIROX solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Rebel Distributors Corp.

INN (Internationale Bezeichnung):

CICLOPIROX

Zusammensetzung:

CICLOPIROX 71.3 mg in 1 mL

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

(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 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. - 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) should be used only under medica

Produktbesonderheiten:

Ciclopirox Topical Solution, 8% (Nail Lacquer) is supplied in 6.6 mL (NDC 21695-475-66) 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.   Rx ONLY

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

CICLOPIROX - CICLOPIROX SOLUTION
REBEL DISTRIBUTORS CORP.
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CICLOPIROX TOPICAL SOLUTION, 8% (NAIL LACQUER)
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.
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
ciclopirox.
One _ex vivo_ stud