TRIAMCINOLONE ACETONIDE cream

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Glenmark Pharmaceuticals Inc., USA

INN (Internationale Bezeichnung):

TRIAMCINOLONE ACETONIDE

Zusammensetzung:

TRIAMCINOLONE ACETONIDE 1 mg in 1 g

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Triamcinolone Acetonide Cream 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.

Produktbesonderheiten:

Triamcinolone Acetonide Cream USP, 0.1% is available as follows: Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. Manufactured by: Glenmark Pharmaceuticals Ltd. Village Kishanpura, Baddi Nalagarh Road, District: Solan,Himachal Pradesh - 173205 India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkpharma.com/usa July 2016

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
GLENMARK PHARMACEUTICALS INC., USA
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TRIAMCINOLONE ACETONIDE CREAM USP, 0.1%
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 USP is designated chemically as 9-Fluoro-11β, 16α, 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 Cream USP, 0.1% contains 1 mg
triamcinolone acetonide USP
in a cream base consisting of emulsifying wax, cetyl alcohol,
isopropyl palmitate, sorbitol solution,
glycerine, lactic acid, benzyl alcohol and purified water.
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. 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 corticostero