CICLOPIROX solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

VersaPharm Incorporated

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 US. In these studies, patients with onychomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solution, 8% in conjunction wi

Product summary:

Ciclopirox topical solution, 8%, is supplied in 6.6 mL (NDC 61748-200-06) glass bottles with screw caps which are fitted with brushes. Protect from light (e.g., store the bottle in the carton after every use). Ciclopirox topical solution, 8%, should be stored 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
VERSAPHARM INCORPORATED
----------
CICLOPIROX TOPICAL SOLUTION, 8% (NAIL LACQUER)
R
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 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%, 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 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_ study was conducted evaluating 8% ciclopirox again