TRIAMCINOLONE ACETONIDE lotion

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Preparatomtale Preparatomtale (SPC)
01-05-2012

Aktiv ingrediens:

TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE - UNII:1ZK20VI6TY)

Tilgjengelig fra:

Physicians Total Care, Inc.

INN (International Name):

TRIAMCINOLONE ACETONIDE

Sammensetning:

TRIAMCINOLONE ACETONIDE 1 mg in 1 mL

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Topical corticosteroids are 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.

Produkt oppsummering:

Triamcinolone Acetonide Lotion, USP 0.1% is supplied in the following size: 60 mL (NDC 54868-3097-0). Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. AVOID FREEZING SHAKE WELL BEFORE USING

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

                                TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE LOTION
PHYSICIANS TOTAL CARE, INC.
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TRIAMCINOLONE ACETONIDE
LOTION, USP 0.1%
FOR TOPICAL USE ONLY
RX ONLY
DESCRIPTION
Triamcinolone Acetonide Lotion, USP is supplied in the following
strengths: 0.025%, 0.1%. Each mL
of Triamcinolone Acetonide Lotion, USP, 0.1%, contains 1 mg
triamcinolone acetonide, USP in a lotion
base containing citric acid, cetyl alcohol, dimethicone, polysorbate
20, propylene glycol, purified
water, sorbitan monopalmitate, and stearyl alcohol. IT MAY CONTAIN 10%
citric acid solution or 10%
sodium citrate solution for pH adjustment.
Triamcinolone Acetonide is a topical corticosteroid known chemically
as 9-Fluoro-11β, 16α, 17, 21-
tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with
acetone.
The molecular formula is C
H FO . It has the following structure:
M.W. 4 34 .51
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 increases 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).
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31
6
Once absorbed through the skin, topical corticosteroids are ha
                                
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