TEVA-CLOBETASOL CREAM

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

CLOBETASOL PROPIONATE

Verfügbar ab:

TEVA CANADA LIMITED

ATC-Code:

D07AD01

INN (Internationale Bezeichnung):

CLOBETASOL

Dosierung:

0.05%

Darreichungsform:

CREAM

Zusammensetzung:

CLOBETASOL PROPIONATE 0.05%

Verabreichungsweg:

TOPICAL

Einheiten im Paket:

15/50/450G

Verschreibungstyp:

Prescription

Therapiebereich:

ANTI-INFLAMMATORY AGENTS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2002-05-01

Fachinformation

PRODUCT MONOGRAPH
PR
TEVA-CLOBETASOL
CLOBETASOL 17-PROPIONATE
0.05%
CREAM, OINTMENT AND SCALP LOTION
TOPICAL ANTI-INFLAMMATORY STEROID
TEVA CANADA LIMITED
DATE OF PREPARATION:
30 NOVOPHARM COURT
TORONTO, ONTARIO
DECEMBER 18, 2017
CANADA M1B 2K9
WWW.TEVACANADA.COM
CONTROL #: 211470
Page 2
PRODUCT MONOGRAPH
PR
TEVA-CLOBETASOL
CLOBETASOL 17-PROTIONATE
0.05%
CREAM, OINTMENT AND SCALP LOTION
TOPICAL ANTI-INFLAMMATORY STEROID
CLINICAL PHARMACOLOGY
ACTIONS
TEVA-CLOBETASOL
(clobetasol
17-propionate
0.05%)
is
a
highly
potent
topical
corticosteroid.
The
corticosteroids
are
a
class
of
compounds
comprising
steroid
hormones that are secreted by the adrenal cortex and their synthetic
analogs. In
pharmacologic doses, corticosteroids are used primarily for their
anti-inflammatory
and/or immunosuppressive effects. Topical corticosteroids such as
clobetasol are
effective in the treatment of corticosteroid-responsive dermatoses
primarily because of
their anti-inflammatory, antipruritic, and vasoconstrictive actions.
PHARMACOKINETICS:
In man, the extent of percutaneous absorption of topical
corticosteroids, including
clobetasol, is determined by many factors, including the vehicle, the
integrity of the
epidermal barrier, and the use of occlusive dressing.
As with all topical corticosteroids, clobetasol 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.
Once
absorbed
through
the
skin,
topical
corticosteroids
enter
pharmacokinetic
pathways
similar
to
systemically administered
corticosteroids.
Corticosteroids are
bound to plasma proteins in varying degrees. Corticosteroids are
metabolized primarily
in the liver and are then excreted by the kidneys. Some of the topical
corticosteroids,
including clobetasol and its metabolites, are also excreted in the
bile.
BIOAVAILABILITY
The relative potency of corticosteroids is usually assayed by the
vasoconstriction te