TRETINOIN cream TRETINOIN gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

TRETINOIN

Composition:

TRETINOIN 0.025 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Tretinoin is 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.

Product summary:

Tretinoin is supplied as:

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRETINOIN - TRETINOIN CREAM
TRETINOIN - TRETINOIN GEL
PHYSICIANS TOTAL CARE, INC.
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TRETINOIN CREAM TRETINOIN GEL - FOR TOPICAL USE ONLY
DES CRIPTION:
Tretinoin Cream and Tretinoin Gel are used for the topical treatment
of acne vulgaris. Tretinoin Gel
contains tretinoin (retinoic acid, vitamin A acid) in either of two
strengths, 0.025% or 0.01% by weight,
in a gel vehicle of butylated hydroxytoluene, hydroxypropyl cellulose
and alcohol (denatured with _tert_-
butyl alcohol and brucine sul-fate) 90% w/w. Tretinoin Cream contains
tretinoin in either of three
strengths, 0.1%, 0.05%, or 0.025% by weight, 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 and
has the following structure:
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 is 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.
PRECAUTIONS :
_GENERAL:_
If a reaction suggesting sensitivity or chemical irritation occurs,
use of the medication should be
discontinued. Exposure to sunlight, including sunlamps, should be
minimized during the use of tretinoin,
and patients with sunburn should be advised not to use the product
until fully recovered because of
heightened susceptibility to sunlight as a result of the use of
tretinoin. Patients who may be required to
have considerable