CICLOPIROX solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Preferred Pharmaceuticals, Inc.

INN (International Name):

CICLOPIROX

Composition:

CICLOPIROX 80 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section 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. The results of use of 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 United States. In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8% in conjun

Product summary:

Ciclopirox Topical Solution, 8% is available as follows: 6.6 mL glass bottle with a screw cap fitted with a brush NDC 68788-6797-6 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CICLOPIROX- CICLOPIROX SOLUTION
PREFERRED PHARMACEUTICALS, INC.
----------
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