Country: Canada
Language: English
Source: Health Canada
TAZAROTENE
ALLERGAN INC
D05AX05
TAZAROTENE
0.05%
GEL
TAZAROTENE 0.05%
TOPICAL
12X3.5G/30G
Prescription
MISC. SKIN AND MUCOUS MEMBRANE AGENTS
Active ingredient group (AIG) number: 0133047001; AHFS:
CANCELLED POST MARKET
2021-11-26
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 Read the complete document