TRIAMCINOLONE ACETONIDE aerosol, spray

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Padagis Israel Pharmaceuticals Ltd

INN (Διεθνής Όνομα):

TRIAMCINOLONE ACETONIDE

Σύνθεση:

TRIAMCINOLONE ACETONIDE 0.147 mg in 1 g

Οδός χορήγησης:

TOPICAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g 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.

Περίληψη προϊόντος:

Triamcinolone Acetonide Topical Aerosol USP, 0.147 mg/g 63 g (NDC 45802-045 -01) aerosol can. 100 g (NDC 45802-045 -02) aerosol can.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE AEROSOL, SPRAY
PADAGIS ISRAEL PHARMACEUTICALS LTD
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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 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
corticosteroid