CICLOPIROX solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

A-S Medication Solutions

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

(To understand fully the indication for this product, please read the entire INDICATION AND USAGE section of the labeling.) Ciclopirox topical solution, USP 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. - No studies have been conducted to determine whether ciclopirox might reduce the effectiveness of systemic antifungal agents for onychomycosis. Therefore, the concomitant use of ciclopirox topical solution, 8% and systemic antifungal agents for onychomycosis, is not recommended. - Ciclopirox topical solution, 8% should be used only under medical supervision as described

Product summary:

Product: 50090-6562 NDC: 50090-6562-0 6.6 mL in a BOTTLE / 1 in a CARTON

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CICLOPIROX - CICLOPIROX SOLUTION
A-S MEDICATION SOLUTIONS
----------
PRESCRIBING INFORMATION
RX ONLY
CICLOPIROX TOPICAL SOLUTION, USP 8% (NAIL LACQUER)
FOR USE ON FINGERNAILS AND TOENAILS AND IMMEDIATELY ADJACENT SKIN
ONLY
NOT FOR USE IN EYES
DESCRIPTION
Ciclopirox Topical Solution, USP 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, USP 8% (Nail Lacquer)
contains 80 mg
ciclopirox in a solution base consisting of ethyl acetate, isopropyl
alcohol and
monobutylester of poly[methyl vinyl ether/maleic acid] in isopropyl
alcohol. Ethyl acetate
and isopropyl alcohol are solvents that vaporize after application.
Ciclopirox Topical Solution, USP 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.
As a consequence, a broad
range of MIC values, 1-20 mcg/mL, were obtained for Trichophyton
rubrum and
12
17
2
+3
+3
(1-2)
Trichophyton mentagrophytes species. Correlation between in vitro MIC
results and
clinical outcome has yet to b