TARO-CICLOPIROX SOLUTION

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CICLOPIROX

제공처:

TARO PHARMACEUTICALS INC

ATC 코드:

D01AE14

INN (국제 이름):

CICLOPIROX

복용량:

8%

약제 형태:

SOLUTION

구성:

CICLOPIROX 8%

관리 경로:

TOPICAL

패키지 단위:

6G

처방전 유형:

Prescription

치료 영역:

HYDROXYPYRIDONES

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2010-06-11

제품 특성 요약

PRODUCT MONOGRAPH
PR
TARO-CICLOPIROX
(Ciclopirox Topical Solution, 8% w/w)
NAIL LACQUER
Topical Antifungal Agent
Taro Pharmaceuticals Inc.
Date of Preparation:
130 East Drive
June 9, 2010
Brampton, Ontario, L6T 1C1
Submission Control No. 125828
2
PRODUCT MONOGRAPH
PR
TARO-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.
Systemic absorption of ciclopirox was determined in 5 patients with
dermatophytic
onychomycoses after application of ciclopirox topical solution, 8%
w/w, to all 20 digits and
adjacent 5 mm of skin once daily for six months. Random serum
concentrations and 24 hour
urinary excretion of ciclopirox were d