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:

Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC

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. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components in the preparation.

Product summary:

Triamcinolone Acetonide Cream USP, 0.1% in 30g tube (NDC: 35356-753-30). Store at controlled room temperature 20° to 25°C (68° to 77°F). Avoid freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC
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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 is designated chemically as
9-Fluoro-11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-
dione cyclic 16,17-acetal with acetone. With the molecular formula of
C
H FO and a molecular
weight of 434.51. The structural formula is:
Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg
Triamcinolone Acetonide in a
cream base consisting of cetyl alcohol, cetyl esters wax, glyceryl
monostearate, isopropyl palmitate,
polysorbate-60, polysorbate-80, propylene glycol and purified water.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic and
vasoconstrictive actions.
The mechanism of anti-inflammatory activity of 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 corticoster