TAZORAC GEL

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

TAZAROTENE

Available from:

ALLERGAN INC

ATC code:

D05AX05

INN (International Name):

TAZAROTENE

Dosage:

0.1%

Pharmaceutical form:

GEL

Composition:

TAZAROTENE 0.1%

Administration route:

TOPICAL

Units in package:

12X3.5G/30G

Prescription type:

Prescription

Therapeutic area:

MISC. SKIN AND MUCOUS MEMBRANE AGENTS

Product summary:

Active ingredient group (AIG) number: 0133047002; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2023-09-22

Summary of Product characteristics

Page 1 of 21
PRODUCT MONOGRAPH
PR TAZORAC
®
Tazarotene gel 0.05% and 0.1% w/w
Anti-Psoriasis and Anti-Acne Agent
Allergan Inc.
Markham, ON
L6G 0B5
Date of Preparation:
February 17, 1997
Date of Revision:
June 29, 2015
Submission Control No: 183295
Page 2 of 21
PRODUCT MONOGRAPH
PR TAZORAC
®
Tazarotene gel 0.05% and 0.1% w/w
THERAPEUTIC CLASSIFICATION
Anti-Psoriatic, Anti-Acne Agent
ACTIONS AND CLINICAL PHARMACOLOGY
Tazarotene is a retinoid prodrug which is converted to its active
form, M1 (“tazarotenic acid”,
or AGN 190299), by rapid deesterification in most biological systems.
“Tazarotenic acid”
binds to and regulates gene expression through all three members of
the RAR family of
retinoid nuclear receptors, RARα, RARβ, and RARγ, but shows
selectivity for RARβ and
RARγ.
PSORIASIS: The exact mechanisms of tazarotene action in psoriasis are
not completely defined.
Among its specific pharmacological activities, demonstrated in
cellular and in _in vivo _studies,
topical tazarotene blocks induction of epidermal ornithine
decarboxylase (ODC) activity,
which is associated with cell proliferation and hyperplasia,
suppresses expression of MRP8,
an inflammatory marker present in psoriatic epidermis at high levels,
and inhibits cornified
envelope formation and build-up, which is an element of psoriatic
scale. Improvement in
psoriatic patients appears to occur in association with restoration of
normal cutaneous
morphology and reduction of the inflammatory markers ICAM-1 and
HLA-DR. There is also
a diminution of markers of epidermal hyperplasia and abnormal
differentiation such as
keratinocyte transglutaminase, involucrin and keratin 16.
In two large vehicle-controlled clinical studies, tazarotene 0.1% and
0.05% gels applied once
daily were significantly more effective than vehicle in reducing the
severity of the clinical
signs of plaque psoriasis. Tazarotene gels demonstrated effectiveness
as early as 1 week after
starting treatment, with initial treatment success (good or excellent
response or complete
cleari