TRETINOIN- tretinoin cream TRETINOIN- tretinoin gel

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)

Tilgjengelig fra:

Rouses Point

INN (International Name):

TRETINOIN

Sammensetning:

TRETINOIN 1 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Tretinoin gel and cream are indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established. Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.

Produkt oppsummering:

Manufactured for Rouses Point Pharmaceuticals, LLC By DPT Laboratories, San Antonio, TX 78215 524F502 Rev. 08/15

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TRETINOIN- TRETINOIN CREAM
TRETINOIN- TRETINOIN GEL
ROUSES POINT
----------
TRETINOIN
PRESCRIBING INFORMATION
DES CRIPTION:
Tretinoin Gel, USP and Tretinoin Cream, USP are used for the topical
treatment of acne vulgaris. Each
gram of tretinoin gel contains tretinoin in either of two strengths,
0.025% (0.25 mg) or 0.01% (0.1 mg)
in a gel vehicle of hydroxypropyl cellulose, butylated hydroxytoluene,
and alcohol (denatured with _tert_-
butyl alcohol and brucine sulfate) 90% w/w. Each gram of tretinoin
cream contains tretinoin in either of
three strengths, 0.1% (1 mg), 0.05% (0.5 mg), or 0.025% (0.25 mg) in a
hydrophilic cream vehicle of:
stearic acid, isopropyl myristate, polyoxyl 40 stearate, stearyl
alcohol, xanthan gum, sorbic acid,
butylated hydroxytoluene, and purified water. Chemically, tretinoin is
_all-trans_-retinoic acid. It has a
molecular weight of 300.44 and has the following structural formula:
CLINICAL PHARMACOLOGY:
Although the exact mode of action of tretinoin is unknown, current
evidence suggests that topical
tretinoin decreases cohesiveness of follicular epithelial cells with
decreased microcomedo formation.
Additionally, tretinoin stimulates mitotic activity and increased
turnover of follicular epithelial cells
causing extrusion of the comedones.
INDICATIONS AND USAGE:
Tretinoin gel and cream are indicated for topical application in the
treatment of acne vulgaris. The
safety and efficacy of the long-term use of this product in the
treatment of other disorders have not been
established.
CONTRAINDICATIONS :
Use of the product should be discontinued if hypersensitivity to any
of the ingredients is noted.
WARNINGS :
GELS ARE FLAMMABLE. AVOID FIRE, FLAME OR SMOKING DURING USE. Keep out
of
reach of children. Keep tube tightly closed. Do not expose to heat or
store at temperatures above 120°F
(49°C).
TRETINOIN GEL, USP RX ONLY
TRETINOIN CREAM, USP FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
PRECAUTIONS :
_GENERAL:_
If a reaction suggesting sensitivity or chemical irritation occurs,
use of the medic