DERMOVATE OINTMENT

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CLOBETASOL PROPIONATE

Available from:

TAROPHARMA, A DIVISION OF TARO PHARMACEUTICALS INC.

ATC code:

D07AD01

INN (International Name):

CLOBETASOL

Dosage:

.05%

Pharmaceutical form:

OINTMENT

Composition:

CLOBETASOL PROPIONATE .05%

Administration route:

TOPICAL

Units in package:

50G

Prescription type:

Prescription

Therapeutic area:

ANTI-INFLAMMATORY AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2003-09-03

Summary of Product characteristics

Prescribing Information
Pr
DERMOVATE
®
Cream
(clobetasol propionate cream, USP)
Pr
DERMOVATE
®
Ointment
(clobetasol propionate ointment, USP)
Topical corticosteroid
TaroPharma
Preparation Date:
A Division of Taro Pharmaceuticals Inc.
Sept 02, 2003
130 East Drive
Brampton, Ontario
Revision Date:
L6T 1C1
August 6, 2003
Control # 086321
1
Prescribing Information
Pr
DERMOVATE
®
Cream
(clobetasol propionate cream, USP)
Pr
DERMOVATE
®
Ointment
(clobetasol propionate ointment, USP)
Topical Corticosteroid
Actions and Clinical Pharmacology
The corticosteroids are a class of compounds comprising steroid
hormones
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
propionate are effective in the treatment of corticosteroid-responsive
dermatoses
primarily because of their anti-inflammatory, anti-pruritic, and
vasoconstrictive
actions. However, while the physiologic, pharmacologic and clinical
effects of the
corticosteroids are well known, the exact mechanisms of their actions
in each
disease are uncertain.
Clobetasol propionate has been shown to have topical and systemic
pharmacologic and metabolic effects characteristic of the
corticosteroid class of
drugs.
2
Indications and Clinical Use
DERMOVATE (clobetasol propionate) Cream and Ointment are indicated for
the
topical therapy of recalcitrant corticosteroid-responsive dermatoses,
including
severe cases of psoriasis (excluding widespread plaque psoriasis) and
eczematous dermatitis.
Contraindications
DERMOVATE (clobetasol propionate) cream and ointment are not indicated
for
the treatment of rosacea, acne vulgaris, perioral dermatitis or
perianal and genital
pruritus. These preparations are contraindicated also in the treatment
of primary
infected bacterial or fungal skin lesions if no anti-infective agent
is used
simultaneously, in primary cutaneous viral infections (i.e., herpes
simplex,
vaccinia and v