CICLOPIROX solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Cosette 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%, (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 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.      • 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),

Product summary:

Ciclopirox Topical Solution, 8%, (Nail Lacquer), is supplied in 3.3 mL (NDC 0713-0317-87) and 6.6 mL (NDC 0713-0317-88) 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CICLOPIROX- CICLOPIROX SOLUTION
COSETTE PHARMACEUTICALS, INC.
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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%, (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.
12
17
2
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