TRIAMCINOLONE ACETONIDE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIAMCINOLONE (UNII: 1ZK20VI6TY) (TRIAMCINOLONE - UNII:1ZK20VI6TY)

Available from:

Ascend Laboratories, LLC

INN (International Name):

TRIAMCINOLONE

Composition:

TRIAMCINOLONE 0.25 mg

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Triamcinolone Acetonide Cream USP is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Triamcinolone Acetonide Cream USP is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Product summary:

Triamcinolone  Acetonide Cream USP, 0.025% 15 gram tubes:  NDC67877-470-75 30 gram tubes:  NDC67877-470-76 80 gram tubes:   NDC67877-470-77 Triamcinolone  Acetonide Cream   USP, 0.1 % 15 gram tubes:  NDC67877-471-75 30 gram tubes:  NDC67877-471-76 80 gram tubes:   NDC67877-471-77 Triamcinolone  Acetonide Cream   USP, 0.5 % 15 gram tubes:   NDC67877-472-75 30 gram tubes:   NDC67877-472-76 80 gram tubes:    NDC67877-472-77 Store at controlled room temperature 15°-30 °C (59°-86°F). Avoid excessive heat. Protect from freezing. Manufactured by: Torrent Pharmaceuticals Ltd. Pithampur-454775, INDIA Distributed by : Ascend Laboratories, LLC Parsippany, NJ 07054 Revised: October, 2017 PT 2326

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE CREAM
ASCEND LABORATORIES, LLC
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TRIAMCINOLONE ACETONIDE CREAM USP 0.025%,0.1%,0.5%
RX ONLY
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory
and anti-pruritic agents. The steroids in this class include
triamcinolone acetonide. Triamcinolone
Acetonide Cream USP contains Triamcinolone Acetonide [Pregna-1,4
-diene-3,20 -dione,9 -fluoro -
11,21-dihydro xy-16 ,17-[(1-methylethylidene)bis- (oxy)]-, (11β,16
α)-], with the empirical formula
C24H31FO6 and molecular weight 434.50 .CAS 76-25-5.
The structural formula is:
Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 mg of
Triamcinolone Acetonide per gram
in a base containing Glycerin, Cetyl Alcohol,Isopropyl
Palmitate,Noncrystallizing sorbitol
solution,Emulsifying Wax,Lactic Acid,Benzyl Alcohol andPurified Water.
Triamcinolone Acetonide Cream USP, 0.1% contains: 1mg of Triamcinolone
Acetonide per gram in a
base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate,
Noncrystallizing sorbitol solution,
Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water.
Triamcinolone Acetonide Cream USP, 0.5% contains: 5 mg of
Triamcinolone Acetonide per gram in a
base containing Glycerin, Cetyl Alcohol, Isopropyl Palmitate,
Noncrystallizing sorbitol solution,
Emulsifying Wax, Lactic Acid, Benzyl Alcohol and Purified Water.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, anti-pruritic and
vasoconstrictive actions. The
mechanism of anti-inflammatory activity of the topical corticosteroids
is unclear. Various laboratory
methods, including vasoconstrictor assays, are used to compare and
predict potencies and/or clinical
efficacies of the topical corticosteroids. There is some evidence to
suggest that a recognizable
correlation exists between vasoconstrictor potency and therapeutic
efficacy in man.
PHARMACOKINETICS
The extent of percutaneous absorption of topical corticosteroids is
determined by many factors
including the