TRIAMCINOLONE ACETONIDE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)

Available from:

Strides Pharma Science Limited

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Triamcinolone Acetonide Cream 0.025%, 0.1%, and 0.5% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Product summary:

Triamcinolone Acetonide Cream USP, is White to off white cream and available as: Store at controlled room temperature 15˚-30˚C (59˚-86˚F). Avoid excessive heat. Protect from freezing. Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by: Strides Pharma Inc. East Brunswick, NJ 08816. Revised: 02/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE CREAM
STRIDES PHARMA SCIENCE LIMITED
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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-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-,
(11β,16α)-], with the empirical formula C
H
FO 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 Emulsifying Wax, Cetyl
Alcohol, Isopropyl
Palmitate, Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol
and Purified Water.
Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of
Triamcinolone Acetonide
per gram in a base containing Emulsifying Wax, Cetyl Alcohol,
Isopropyl Palmitate,
Sorbitol Solution, Glycerin, 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 Emulsifying Wax, Cetyl Alcohol,
Isopropyl Palmitate,
Sorbitol Solution, Glycerin, 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.
24
31
6
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 vehicle, the integrity of the
epi