RETIN-A MICRO GEL

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

TRETINOIN

Tilgjengelig fra:

BAUSCH HEALTH, CANADA INC.

ATC-kode:

D10AD01

INN (International Name):

TRETINOIN

Dosering :

0.04%

Legemiddelform:

GEL

Sammensetning:

TRETINOIN 0.04%

Administreringsrute:

TOPICAL

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

CELL STIMULANTS AND PROLIFERANTS

Produkt oppsummering:

Active ingredient group (AIG) number: 0112395006; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2012-03-20

Preparatomtale

PRODUCT MONOGRAPH
PR
RETIN-A MICRO
®
Tretinoin Gel (microsphere)
0.1% w/w and 0.04% w/w
COMEDOLYTIC AGENT
BAUSCH HEALTH, CANADA INC.
DATE OF REVISION:
2150 St-Elzear Blvd. West
September 29, 2020
Laval, Quebec
H7L 4A8
Submission Control No.: 238486
_Pr_
_RETIN-A MICRO_
_®_
_ Product Monograph Page 2 of 21_
PRODUCT MONOGRAPH
PR
RETIN-A MICRO
Tretinoin Gel (microsphere)
0.1% w/w and 0.04% w/w
CLINICAL PHARMACOLOGY
RETIN-A MICRO tretinoin gel (microsphere) is a novel formulation
containing either 0.1% w/w
or 0.04% w/w tretinoin by weight for the topical treatment of acne
vulgaris.
Tretinoin is a member of the retinoid family of compounds, and an
endogenous metabolite of
Vitamin A.
Tretinoin is highly effective in the treatment of acne, although the
exact mode of action of
tretinoin is unknown. Current evidence suggests that this efficacy is
due primarily to the ability
of tretinoin to modify abnormal follicular keratinization. Comedones
form in follicles due to
abnormal keratinization and intercellular cohesiveness, with an excess
of keratin retained in the
follicle. Tretinoin promotes detachment of cornified cells and the
enhanced shedding of
corneocytes from the follicle. By increasing the mitotic activity of
follicular epithelia, tretinoin
also increases the turnover rates of thin, loosely adherent
corneocytes. Through these actions, the
comedo contents are extruded and the formation of the microcomedo, the
precursor lesion of
acne vulgaris, is reduced.
Additionally, tretinoin acts by modulating the proliferation and
differentiation of epidermal cells.
These effects are mediated by tretinoin’s interaction with a family
of nuclear retinoic acid
receptors. Activation of these nuclear receptors causes changes in
gene expression. The exact
mechanisms whereby tretinoin-induced changes in gene expression
regulate skin function are not
understood.
This formulation uses patented methyl methacrylate/glycol
dimethacrylate crosspolymer porous
microspheres (MICROSPONGE System) to enable inclusion of the active
ingredient