TRETINOIN cream TRETINOIN gel

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Mylan Pharmaceuticals Inc.

Administracija rute:

TOPICAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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.

Proizvod sažetak:

Tretinoin is supplied as: Tretinoin Cream NDC Code Strength/Form Qty 0378-8082-20 0378-8082-45 0.025% Cream 0.025% Cream 20 g 45 g 0378-8083-20 0378-8083-45 0.05% Cream 0.05% Cream 20 g 45 g 0378-8084-20 0378-8084-45 0.1% Cream 0.1% Cream 20 g 45 g Tretinoin Gel NDC Code Strength/Form Qty 0378-8085-15 0378-8085-45 0.01% Gel 0.01% Gel 15 g 45 g 0378-8086-15 0378-8086-45 0.025% Gel 0.025% Gel 15 g 45 g Storage Conditions: Tretinoin Gel, 0.025% and 0.01%: store below 86°F. Tretinoin Cream, 0.1%, 0.05%, and 0.025%: store below 80°F. Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. Manufactured by: Bausch Health Companies Inc. Laval, Quebec H7L 4A8, Canada Revised: 02/2024 VAL:TRETCG:R2 9631002

Status autorizacije:

New Drug Application Authorized Generic

Svojstava lijeka

TRETINOIN- TRETINOIN CREAM
TRETINOIN- TRETINOIN GEL
MYLAN PHARMACEUTICALS INC.
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TRETINOIN CREAM – TRETINOIN GEL
CREAM – GEL
FOR TOPICAL USE ONLY
DESCRIPTION
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
sulfate) 90% w/w.
Tretinoin Cream contains tretinoin in one 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 sun