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:

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

Product summary:

Triamcinolone acetonide cream USP 0.1% is supplied in 15 g tube NDC 68788-6869-1 80 g tube NDC 68788-6869-8 Store at 20-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. PRINTED IN USA Manufactured for:  Ascend Laboratories, LLC Montvale, NJ 07645 Manufactured by: Crown Laboratories, Inc. Johnson City, TN 37604 P1810.01 Revised: Sept 2015 Relabeled By: Preferred Pharmaceuticals Inc.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
PREFERRED PHARMACEUTICALS INC.
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DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory
and antipruritic agents. Triamcinolone acetonide is a member of this
class. Chemically triamcinolone
acetonide is pregna-1, 4-diene-3, 20-dione, 9-flouro-11,
21-dihydroxy-16, 17-[(1-
methylethylidene)bis(oxy)]-(11β16a). Its structural formula is:
Each gram of Triamcinolone Acetonide Cream USP, 0.025 % contains 0.25
mg triamcinolone acetonide
USP in a cream base consisting of purified water, emulsifying wax,
mineral oil, propylene glycol,
sorbitol solution, cetyl palmitate, sorbic acid, and potassium
sorbate.
Each gram of Triamcinolone Acetonide Cream USP, 0.1 % contains 1 mg
triamcinolone acetonide USP
in a cream base consisting of purified water, emulsifying wax, mineral
oil, propylene glycol, sorbitol
solution, cetyl palmitate, sorbic acid, and potassium sorbate.
Each gram of Triamcinolone Acetonide Cream USP, 0.5 % contains 5 mg
triamcinolone acetonide USP
in a cream base consisting of purified water, emulsifying wax, mineral
oil, propylene glycol, sorbitol
solution, cetyl palmitate, sorbic acid, and potassium sorbate.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic 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/