PMS-CICLOPIROX SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CICLOPIROX

Mevcut itibaren:

PHARMASCIENCE INC

ATC kodu:

D01AE14

INN (International Adı):

CICLOPIROX

Doz:

8%

Farmasötik formu:

SOLUTION

Kompozisyon:

CICLOPIROX 8%

Uygulama yolu:

TOPICAL

Paketteki üniteler:

12G

Reçete türü:

Prescription

Terapötik alanı:

HYDROXYPYRIDONES

Ürün özeti:

Active ingredient group (AIG) number: 0150022001; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2013-09-30

Ürün özellikleri

PRODUCT MONOGRAPH
PR
PMS-CICLOPIROX
Ciclopirox Topical Solution, USP
8 % w/w
NAIL LACQUER
Topical Antifungal Agent
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
www.pharmascience.com
Date of Preparation:
September 27, 2013
Submission Control No: 161450
_pms-CICLOPIROX Product Monograph _
_Page 2 of 25_
PRODUCT MONOGRAPH
Pr
pms-CICLOPIROX
(Ciclopirox Topical Solution, 8% w
/
w)
NAIL LACQUER
Topical Antifungal
Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Ciclopirox free acid is an antimycotic agent that inhibits the growth
of a number of fungi _in vitro _
including
_Trichophyton _
_mentagrophytes_,
_Trichophyton _
_rubrum_,
_Microsporum _
_canis_,
_Epidermophyton _
_floccosum_,
_Candida _
_albicans_,
_Candida _
_tropicalis _
and
_Candida _
_pseudotropicalis_.
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.
Pharmacokinetics
As demonstrated in pharmacokinetic studies in animals and man,
ciclopirox olamine is rapidly
absorbed after oral administration and completely eliminated in all
species via feces and urine.
Most of the compound is excreted either unchanged or as glucuronide.
After oral administration
of 10 mg of radiolabelled drug (
14
C-ciclopirox) to healthy volunteers, approximately 96% of the
radioactivity was excreted renally within 12 hours of administration.
Ninety-four percent of the
renally excreted radioactivity was in the form of glucuronides. Thus,
glucuronidation is the main
metabolic pathway of this compound.
_pms-CICLOPIROX Product Monograph _
_Page 3 of 25_
Systemic
absorption
of
ciclopirox
was
determined
in
5
patients
with
dermatophytic
onychomycoses after application of c iclopirox topical solution, 8%
w