TRIAMCINOLONE ACETONIDE cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

Triamcinolone Acetonide (UNII: F446C597KA) (Triamcinolone Acetonide - UNII:F446C597KA)

Tilgjengelig fra:

Taro Pharmaceuticals U.S.A., Inc.

INN (International Name):

Triamcinolone Acetonide

Sammensetning:

Triamcinolone Acetonide 1 mg in 1 g

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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 preparations.

Produkt oppsummering:

Triamcinolone Acetonide Cream USP, 0.1% in 15 g (NDC 51672-1282-1), 30 g (NDC 51672-1282-2) and 80 g (NDC 51672-1282-8) tubes. Store at controlled room temperature 20° to 25°C (68° to 77°F). Avoid freezing.

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
TARO PHARMACEUTICALS U.S.A., 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 is designated chemically as
9-Fluoro-11β, 16α,
17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with
acetone.
C
H
FO , MOLECULAR WEIGHT: 434.50
Each gram of 0.1% triamcinolone acetonide cream provides 1 mg
triamcinolone
acetonide, respectively, in a vanishing cream base containing 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 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
24 31
6
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 similar to syst