TRIAMCINOLONE ACETONIDE ointment

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Fachinformation Fachinformation (SPC)
23-02-2011

Wirkstoff:

TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE - UNII:1ZK20VI6TY)

Verfügbar ab:

Physicians Total Care, Inc.

INN (Internationale Bezeichnung):

TRIAMCINOLONE ACETONIDE

Zusammensetzung:

TRIAMCINOLONE ACETONIDE 0.25 mg in 1 g

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

Topical corticosteroids are 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 preparation.

Produktbesonderheiten:

Triamcinolone Acetonide Ointment USP are supplied as follows: Store at controlled room temperature 15° to 30°C (59° to 86°F). DISTRIBUTED BY PERRIGO, ALLEGAN, MI 49010 4B400 RC J1

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

                                TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE OINTMENT
PHYSICIANS TOTAL CARE, INC.
----------
RX ONLY
DESCRIPTION
The topical corticosteriods constitute a class of primarily synthetic
steroids used as anti-inflammatory
and antipruritic agents.
Triamcinolone acetonide is designated chemically as
pregna-1,4-diene-3, 20-dione, 9-fluoro-11, 21-
dihydroxy-16, 17-[(1-methylethylidene)bis (0xy)]-, (11β, 16α)-. C
H FO ,M.W.:434.51; CAS
Reg.No.:76-25-5.
Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Cream USP
provides 0.25 mg, 1 mg,
or 5 mg triamcinolone acetonide respectively in a washable cream base
of : Purified Water, Cetyl
Alcohol, Propylene Glycol, Glyceryl Monostearate, Glycerin, Cetyl
Esters Wax, Polysorbate-60,
Sorbitan Monostearate, Isopropyl Palmitate and Sorbic Acid.
Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Ointment
USP provides 0.25 mg, 1 mg,
or 5 mg triamcinolone acetonide respectively in an ointment base of
White Petrolatum and Light Mineral
Oil.
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
                                
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