TRIAMCINOLONE ACETONIDE aerosol, spray

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Rising Pharmaceuticals, Inc.

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Triamcinolone Acetonide Topical Aerosol, USP is indicated for 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.

Produktbesonderheiten:

Triamcinolone Acetonide Topical Aerosol, USP is a clear, colorless liquid that is practically free from visible impurities. It has an odor characteristic of ethanol. It is supplied as follows: 63 g (NDC 64980-429-63) aerosol can. 100 g (NDC 64980-429-01) aerosol can. Storage and Handling Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Contents under pressure; do not puncture or incinerate. Keep out of reach of children. Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663 Rev. 11/2018 Made in USA

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE AEROSOL, SPRAY
RISING PHARMACEUTICALS, INC.
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TRIAMCINOLONE ACETONIDE TOPICAL AEROSOL, USP
(0.147 MG/G)
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
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. The structural formula is:
A two-second application, which covers an area approximately the size
of the hand, delivers an amount
of triamcinolone acetonide not exceeding 0.2 mg. After spraying, the
nonvolatile vehicle remaining on
the skin contains approximately 0.2% triamcinolone acetonide. Each
gram of spray provides 0.147 mg
triamcinolone acetonide, USP in a vehicle of isopropyl palmitate,
dehydrated alcohol (10.3%), and
isobutane propellant.
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 other disease
processes in the skin increase percutaneous absorption.
Once absorbed through the skin, topical corticosteroids are handled
through pharmacokinetic pathways
similar to systemically administered corticostero