TRIAMCINOLONE ACETONIDE- 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:

Teligent Pharma, Inc.

INN (International Name):

triamcinolone acetonide

Composition:

triamcinolone acetonide 1 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Triamcinolone acetonide cream 0.1% is 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, 0.1% is supplied in the following: 15 g tube (NDC: 68788-7120-1) 80 g tube (NDC: 68788-7120-8) Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Revised: 04/2017 Relabeled By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
TELIGENT PHARMA, INC.
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TRIAMCINOLONE ACETONIDE CREAM USP, 0.1%
RX ONLY
DESCRIPTION:
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory
and antipruritic 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.
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.
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 vehicle, the integrity of the epidermal
barrier, and the use of occlusive
dressings. Topical corticosteroids can be absorbed from normal intact
skin. Inflammation and/or other
disease processes in the skin increase percutaneous absorption.
Occlusive dressings substantially
increase the percutaneous absorption of topical corticosteroids. Thus,
occlusive dressings may be a
valuable therapeutic adjunct for treatment of resistant dermatoses
(See DOSAGE AND
ADMINISTRATION). Once absorbed through the skin, topical
corticosteroids are handled through
pharmacokinetic pathways simila