Ülke: Kanada
Dil: İngilizce
Kaynak: Health Canada
TRETINOIN
GLAXOSMITHKLINE INC
D10AD01
TRETINOIN
0.025%
CREAM
TRETINOIN 0.025%
TOPICAL
20G
Prescription
CELL STIMULANTS AND PROLIFERANTS
Active ingredient group (AIG) number: 0112395002; AHFS:
CANCELLED POST MARKET
2014-05-01
_2014-01-30/131-pristine-english-rejuva-a.doc _ _ _ _ _ _Page 1 of 19_ PRODUCT MONOGRAPH PR REJUVA-A ® Tretinoin cream USP 0.025% w/w AGENT FOR THE TREATMENT OF PHOTODAMAGED SKIN GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 www.stiefel.ca Date of Revision: January 30, 2014 Control No.: 169514 _©_ _2014 GlaxoSmithKline Inc., All Rights Reserved _ _®_ _REJUVA-A and _ _®_ _STIEVA-A are registered trademarks owned by GlaxoSmithKline Inc. _ _2014-01-30/131-pristine-english-rejuva-a.doc _ _ _ _ _ _Page 2 of 19_ PRODUCT MONOGRAPH PR REJUVA-A ® Tretinoin cream USP 0.025% w/w THERAPEUTIC CLASSIFICATION AGENT FOR THE TREATMENT OF PHOTODAMAGED SKIN ACTIONS AND CLINICAL PHARMACOLOGY ACTION AND CLINICAL PHARMACOLOGY Tretinoin, a member of the retinoid class of compounds, is both pharmacologically and structurally related to vitamin A, which regulates epithelial cell growth and differentiation. Retinoic acid may exert its effects at the molecular level by binding to specific steroid- like nuclear receptors known as retinoic acid receptors. Binding of retinoic acid to a retinoic acid receptor will promote events at the cellular level by regulating gene transcription and affecting activities such as cellular differentiation and proliferation, but the exact mechanism underlying these processes remain to be elucidated. Topical tretinoin has been reported to correct many of the structural abnormalities of photo aged skin. Tretinoin has been shown to produce epidermal and dermal changes. At the epidermal level, tretinoin increased the epidermal thickness (acanthosis) and the mean granular layer, decreased tonofilament and desmosome strength and increased secretion of a glycosaminoglycan-like substance into the intercellular space. In addition, the cohesion of the epidermal cells and activity of the melanocytes were reduced. Functional changes in the epidermis include an increase in trans-epidermal water loss and permeability. At the level of the dermis, vasodilatation and angiogenesis of the superfici Belgenin tamamını okuyun