MYLAN-CLOBETASOL OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLOBETASOL PROPIONATE

Available from:

MYLAN PHARMACEUTICALS ULC

ATC code:

D07AD01

INN (International Name):

CLOBETASOL

Dosage:

0.05%

Pharmaceutical form:

OINTMENT

Composition:

CLOBETASOL PROPIONATE 0.05%

Administration route:

TOPICAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2009-06-03

Summary of Product characteristics

PRODUCT MONOGRAPH
MYLAN-CLOBETASOL OINTMENT
(Clobetasol 17-propionate Ointment 0.05% w/w)
Topical Corticosteroid
Mylan Pharmaceuticals ULC
37 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Preparation:
June 5, 2009
Date of Revision
Control#: 129663
2
PRODUCT MONOGRAPH
MYLAN-CLOBETASOL OINTMENT
(Clobetasol 17-propionate Ointment 0.05% w/w)
THERAPEUTIC CLASSIFICATION
Topical Corticosteroid
ACTIONS AND CLINICAL PHARMACOLOGY
MYLAN-CLOBETASOL (clobetasol 17-propionate) Ointment 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 17-propionate,
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
17-propionate, 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 17- 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.
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
3
then excreted by the kidneys. Some of the topical corticosteroids,
including clobetasol 17-
propionate and its metabolites, are also excreted in the bile.
INDICATIONS AND CLINICAL USE
MYLAN-CLOBETASOL
(clobetasol 17-p