TRIAMCINOLONE ACETONIDE cream

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Produktets egenskaber Produktets egenskaber (SPC)
21-01-2020

Aktiv bestanddel:

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

Tilgængelig fra:

NuCare Pharmaceuticals, Inc.

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

Triamcinolone acetonide cream USP 0.1% is supplied in 15 g tube NDC 66267-935-15 Store at 20-25 0 C (68 0 -77 0 F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

                                TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
NUCARE 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/or
                                
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