TAZORAC CREAM

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:

CREAM

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:

2022-03-08

Summary of Product characteristics

PRODUCT MONOGRAPH
PR
TAZORAC
®
Tazarotene Cream 0.05% and 0.1% w/w
Anti-Psoriasis Agent
Anti-Acne Agent
Agent for the Treatment of Photodamaged Skin
Allergan Inc.
Markham, ON
L6G 0B5
Control No.: 187510
Date of Preparation:
February 17, 1997
Date of Revision:
December 8, 2015
Page 2 of 25
PRODUCT MONOGRAPH
PR
TAZORAC
®
Tazarotene Cream 0.05% and 0.1% w/w
THERAPEUTIC CLASSIFICATION
Anti-Psoriasis Agent
Anti-Acne Agent
Agent for the Treatment of Photodamaged Skin
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.
Tazarotene also induces the expression to TIG3 (tazarotene induced
gene 3), a tumour
suppressor, which may inhibit epidermal hyperproliferation in treated
plaques. Tazarotene,
therefore, has multiple effects on keratinocyte differentiation and
proliferation, as well as on
inflammatory processes whi