CICLOPIROX TOPICAL SOLUTION

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

CICLOPIROX

Sẵn có từ:

STERIMAX INC

Mã ATC:

D01AE14

INN (Tên quốc tế):

CICLOPIROX

Liều dùng:

8%

Dạng dược phẩm:

SOLUTION

Thành phần:

CICLOPIROX 8%

Tuyến hành chính:

TOPICAL

Các đơn vị trong gói:

6.6ML

Loại thuốc theo toa:

Prescription

Khu trị liệu:

HYDROXYPYRIDONES

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

CANCELLED POST MARKET

Ngày ủy quyền:

2021-02-18

Đặc tính sản phẩm

PRODUCT MONOGRAPH
PR
CICLOPIROX TOPICAL SOLUTION
(Ciclopirox Topical Solution, House Std)
8% W/W
NAIL LACQUER
Topical Antifungal Agent
SteriMax Inc.
1-2735 Matheson Blvd. East
Mississauga ON
L4W 4M8
Date of Preparation:
August 6, 2013
Submission Control No: 151805
PRODUCT MONOGRAPH
PR
CICLOPIROX TOPICAL SOLUTION
Ciclopirox Topical Solution, House Std
8% w/w
NAIL LACQUER
Topical Antifungal Agent
ACTION 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.
Systemic absorption of ciclopirox was determined in 5 patients with
dermatophytic
onychomycoses after application of ciclopirox topical solution, 8% w/w
nail laquer, to all 20
digits and adjacent 5 mm of skin once daily for six months. Random
serum concentrations an