PMS-CLOBETASOL OINTMENT

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

CLOBETASOL PROPIONATE

Предлага се от:

PHARMASCIENCE INC

АТС код:

D07AD01

INN (Международно Name):

CLOBETASOL

дозиране:

0.05%

Лекарствена форма:

OINTMENT

Композиция:

CLOBETASOL PROPIONATE 0.05%

Начин на приложение:

TOPICAL

Броя в опаковка:

15GM/50GM

Вид предписание :

Prescription

Терапевтична област:

ANTI-INFLAMMATORY AGENTS

Каталог на резюме:

Active ingredient group (AIG) number: 0110995001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2008-05-01

Данни за продукта

PRODUCT MONOGRAPH
Pr
pms-CLOBETASOL
(Clobetasol Propionate)
Topical Cream and Ointment (0.05% w/w)
Topical Anti-inflammatory Steroid
Pharmascience Inc.
Date of Preparation:
6111 Royalmount Ave, Suite #100 April 23, 2008
Montréal, Québec
H4P 2T4
Control#:121454
2
PRODUCT MONOGRAPH
pms-CLOBETASOL
(Clobetasol Propionate)
Topical Cream and Ointment (0.05% w/w)
THERAPEUTIC CLASSIFICATION
Topical Anti-inflammatory Steroid
ACTION AND CLINICAL PHARMACOLOGY
Clobetasol propionate is a highly potent fluorinated corticosteroid
and has been shown
to
have
topical
(dermatologic)
and
systemic
pharmacologic
and
metabolic
effects
characteristic
to
the
corticosteroids.
Corticosteroids
are
a
class
of
compounds
comprising steroid hormones secreted by the adrenal cortex, and their
synthetic analogs.
They are primarily used for their anti-inflammatory and/or
immunosuppressive effects.
pms-CLOBETASOL
(clobetasol
propionate)
is
effective
in
the
treatment
of
corticosteroid
responsive
dermatoses
primarily
due
to
its
anti-inflammatory,
anti-
pruritic, and vasoconstrictive actions. Its exact mechanism of action
however, has not
been fully elucidated.
Pharmacokinetics: As with all topical corticosteroids, clobetasol
propionate can be
absorbed from normal intact skin. Inflammation and/or other disease
processes in the
skin may increase percutaneous absorption. Occlusive dressings
substantially increase
the
percutaneous
absorption
of
topical
corticosteroids
(see
DOSAGE
AND
ADMINISTRATION). Once absorbed, topical corticosteroids enter
pharmacokinetic
3
pathways similar to systemically administered corticosteroids.
Corticosteroids are bound to
plasma proteins in varying degrees. They are primarily metabolized in
the liver and excreted by
the kidneys and in the bile.
Clobetasol propionate cream has been shown to depress the plasma
levels of adrenal cortical
hormones following repeated nonocclusive application to diseased skin
in patients with psoriasis
and eczematous dermatitis. These effects have been shown to be
transient and reversible upon
c