VITAMIN A ACID 0.01% CREAM

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TRETINOIN

Tersedia dari:

SANOFI-AVENTIS CANADA INC

Kode ATC:

D10AD01

INN (Nama Internasional):

TRETINOIN

Dosis:

0.01%

Bentuk farmasi:

CREAM

Komposisi:

TRETINOIN 0.01%

Rute administrasi :

TOPICAL

Unit dalam paket:

25GM

Jenis Resep:

Prescription

Area terapi:

CELL STIMULANTS AND PROLIFERANTS

Ringkasan produk:

Active ingredient group (AIG) number: 0112395003; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2008-08-04

Karakteristik produk

PRODUCT MONOGRAPH
VITAMIN A ACID
®
0.01% or 0.025% or 0.05% Gel
0.01% or 0.025% or 0.05% or 0.1% Cream
TOPICAL ACNE THERAPY
sanofi-aventis Canada Inc.
Date of Preparation:
2150 St. Elzear Blvd. West
May 8, 2006
Laval, Quebec H7L 4A8
Submission Control No. 106119
s-a Version 1.0 dated
2
NAME OF DRUG
VITAMIN A ACID
®
0.01% or 0.025% or 0.05% Gel
0.01% or 0.025% or 0.05% or 0.1% Cream
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.
3
WARNINGS
Use in Pregnancy: Topical Vitamin A Acid should be used by women of
childbearing
years only after contraceptive