CICLOPIROX solution

Země: Spojené státy

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktivní složka:

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

Dostupné s:

Akorn

INN (Mezinárodní Name):

CICLOPIROX

Složení:

CICLOPIROX 71.3 mg in 1 mL

Podání:

TOPICAL

Druh předpisu:

PRESCRIPTION DRUG

Terapeutické indikace:

(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 Tricho-phyto 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% (Nail Lacquer) 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 onchomycosis of the great toenails without lunula involvement were treated with ciclopirox topical solu

Přehled produktů:

Ciclopirox Topical Solution, 8% (Nail Lacquer) is supplied in 3.3 mL (NDC 50383-419-03) and 6.6 mL (NDC 50383-419-06) 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% (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

Stav Autorizace:

Abbreviated New Drug Application

Charakteristika produktu

CICLOPIROX- CICLOPIROX SOLUTION
AKORN
----------
CICLOPIROX TOPICAL SOLUTION, 8% (NAIL LACQUER)
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.
ACTIVITY IN VITRO AND EX VIVO
_In vitro_ methodologies employing various broth or solid media with
and without
12
17
2
_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
clinic