TRIAMCINOLONE ACETONIDE aerosol, spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Versapharm Incorporated

INN (International Name):

TRIAMCINOLONE ACETONIDE

Composition:

TRIAMCINOLONE ACETONIDE 0.147 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g 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 61748-218-63) aerosol can. 100 g (NDC 61748-218-10) aerosol can. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]; avoid excessive heat. Contents under pressure; do not puncture or incinerate. Keep out of reach of children. To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . Manufactured for: VersaPharm Inc. - An Akorn Company Lake Forest, IL 60045 TAA00N Revised: 02/2018

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE AEROSOL, SPRAY
VERSAPHARM INCORPORATED
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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:
C
H FO MW 434.50
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 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 cortic