TRETINOIN- tretinoin cream TRETINOIN- tretinoin gel

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

Rouses Point

INN (Tên quốc tế):

TRETINOIN

Thành phần:

TRETINOIN 1 mg in 1 g

Tuyến hành chính:

TOPICAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

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.

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

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