CICLOPIROX solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Ciclopirox (UNII: 19W019ZDRJ) (Ciclopirox - UNII:19W019ZDRJ)

Available from:

Harris Pharmaceutical, Inc.

INN (International Name):

Ciclopirox

Composition:

Ciclopirox 80 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CICLOPIROX- CICLOPIROX SOLUTION
HARRIS PHARMACEUTICAL, INC.
----------
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+ 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.(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 _study was conducted evaluating 8% ciclopirox