VITAMIN A ACID GEL

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

TRETINOIN

Beschikbaar vanaf:

BAUSCH HEALTH, CANADA INC.

ATC-code:

D10AD01

INN (Algemene Internationale Benaming):

TRETINOIN

Dosering:

0.05%

farmaceutische vorm:

GEL

Samenstelling:

TRETINOIN 0.05%

Toedieningsweg:

TOPICAL

Eenheden in pakket:

25G

Prescription-type:

Prescription

Therapeutisch gebied:

CELL STIMULANTS AND PROLIFERANTS

Product samenvatting:

Active ingredient group (AIG) number: 0112395001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2002-03-11

Productkenmerken

PRODUCT MONOGRAPH
PR
VITAMIN A ACID
Tretinoin gel, Manufacturer’s Standard
0.01 % w/w, 0.025% w/w and 0.05% w/w
TOPICAL ACNE THERAPY
BAUSCH HEALTH, CANADA INC.
DATE OF REVISION:
2150 St-Elzear Blvd. West
September 29, 2020
Laval, Quebec
H7L 4A8
Control #: 238421
_Pr_
_VITAMIN A ACID Product Monograph _
_ Page 2 of 13_
_ _
NAME OF DRUG
PR
VITAMIN A ACID
Tretinoin gel, Manufacturer’s Standard
0.01 % w/w, 0.025% w/w and 0.05% w/w
THERAPEUTIC CLASSIFICATION
Topical Acne Therapy
ACTIONS, CLINICAL PHARMACOLOGY
The interest in oral Vitamin A in the treatment of acne started some
30 years ago following
publication of a report by Straumfjord
1
and theoretical support for the use of the vitamin in the
reduction of hyperkeratosis came from basic science investigations.
Hunter and Pinkus
2
showed a
reduction in the number of keratinocytes in the human _stratum
corneum_ during oral Vitamin A
therapy. Fell and Mellanby
3
noticed a suppression of keratinization by excessive Vitamin A in
tissue culture. This led to the opinion that Vitamin A is
antikeratinizing.
Topical use of Vitamin A was suggested as a means of reducing systemic
toxicity from Vitamin
A taken orally and a number of topical forms of Vitamin A were tried.
VITAMIN A ACID was
found to be the most potent because of its greater peeling action.
VITAMIN A ACID has a very pronounced keratolytic action according to
both Von Beer
4
and
Von Stuttgen
5
. This action has led to its use in a number of dermatological
conditions. It was
tried successfully by Kligman et al
6
in the treatment of acne vulgaris since follicular
hyperkeratosis is considered as being an initial stage of acne.
INDICATIONS AND CLINICAL USES
VITAMIN A ACID Gel is indicated for topical application in the
treatment of acne vulgaris,
primarily Grades I, II and III in which comedones, papules and
pustules predominate.
CONTRAINDICATIONS
Use of the gel should be discontinued if hypersensitivity to any of
the ingredients is noted.
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_VITAMIN A ACID Product Monograph _
_ Page 3 of 13_
_ _
WARNINGS
_USE