REJUVA-A CREAM

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

TRETINOIN

Διαθέσιμο από:

GLAXOSMITHKLINE INC

Φαρμακολογική κατηγορία (ATC):

D10AD01

INN (Διεθνής Όνομα):

TRETINOIN

Δοσολογία:

0.025%

Φαρμακοτεχνική μορφή:

CREAM

Σύνθεση:

TRETINOIN 0.025%

Οδός χορήγησης:

TOPICAL

Μονάδες σε πακέτο:

20G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

CELL STIMULANTS AND PROLIFERANTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0112395002; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2014-05-01

Αρχείο Π.Χ.Π.

_2014-01-30/131-pristine-english-rejuva-a.doc _
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_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