TRIAMCINOLONE ACETONIDE ointment

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

Novel Laboratories, Inc.

Droga podania:

TOPICAL

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

Triamcinolone Acetonide Ointment USP, 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.

Podsumowanie produktu:

Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 g tube (NDC 40032-097-15) 80 g tube (NDC 40032-097-80) STORAGE Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873 PI0970000101 Iss. 03/2016

Status autoryzacji:

Abbreviated New Drug Application

Charakterystyka produktu

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE OINTMENT
NOVEL LABORATORIES, INC.
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TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1%
RX ONLY
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory
and anti-pruritic agents. The steroids in this class include
triamcinolone acetonide. Triamcinolone
acetonide is designated chemically as 9-Fluoro-11b, 16a, 17,
21-tetrahydroxypregna-1,4-diene-3,20-
dione cyclic 16,17-acetal with acetone.
Graphic Formula:
C
H FO , M.W. 434.50
Each gram of Triamcinolone Acetonide Ointment USP, 0.1% contains 1 mg
triamcinolone acetonide, in
an ointment base of light mineral oil and white petrolatum.
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 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 systemically administered corticosteroids. Corticosteroids
are bound to plasma proteins in
24
31
6
varying degrees. Corticosteroids are