CICLODAN- ciclopirox solution

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

ciclopirox (UNII: 19W019ZDRJ) (ciclopirox - UNII:19W019ZDRJ)

Διαθέσιμο από:

Medimetriks Pharmaceuticals, Inc.

INN (Διεθνής Όνομα):

ciclopirox

Σύνθεση:

ciclopirox 2.28 g in 1 mL

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

(To understand fully the indication for this product, please read the entire INDICATIONS AND USAGE section of the labeling.) Ciclodan® 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), should be used on

Περίληψη προϊόντος:

Ciclodan® Ciclopirox Topical Solution, 8%, (Nail Lacquer), is supplied in a 6.6 mL (NDC 43538-500-06) glass bottle with a screw cap which is fitted with a brush. Protect from light (e.g., store the bottle in the carton after every use). Ciclodan® 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. Rx only

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

CICLODAN- CICLOPIROX SOLUTION
MEDIMETRIKS PHARMACEUTICALS, INC.
----------
CICLODAN
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
Ciclodan 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 Ciclodan 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.
Ciclodan 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_
®
_x_
®
®
®
12
17
2
+3
+3
_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 _Trichophyton mentagrophytes_ species.
Correlation between _in vitro_ MIC
results a