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:

Ascend Laboratories, LLC

INN (Internationale Bezeichnung):

TRIAMCINOLONE ACETONIDE

Zusammensetzung:

TRIAMCINOLONE ACETONIDE 1 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 Cream USP, 0.025% is supplied in: 15 grams tube NDC 67877-317-15 80 grams tube NDC 67877-317-80 454 grams jar NDC 67877-317-45 Triamcinolone Acetonide Cream USP, 0.1% is supplied in: 15 grams tube NDC 67877-251-15 30 grams tube NDC 67877-251-30 80 grams tube NDC 67877-251-80 454 grams jar NDC 67877-251-45 Triamcinolone Acetonide Cream USP, 0.5% is supplied in: 15 grams tube NDC 67877-318-15 Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. PRINTED IN USA Manufactured for: Ascend Laboratories, LLC, Parsippany, NJ 07054 Manufactured by: Crown Laboratories, Inc., Johnson City, TN 37604 P1810.02                                                                            Revised: DEC 2016

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE CREAM
ASCEND LABORATORIES, LLC
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DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-
inflammatory and antipruritic agents. Triamcinolone acetonide is a
member of this class.
Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione,
9-fluoro-11, 21-
dihydroxy-16, 17-[(1-methylethylidene) bis(oxy)]-(11β16α) Its
structural formula is:
Each gram of Triamcinolone Acetonide Cream USP, 0.025% contains 0.25
mg
triamcinolone acetonide USP in a cream base consisting of purified
water, emulsifying
wax, mineral oil, propylene glycol, sorbitol solution, cetyl
palmitate, sorbic acid, and
potassium sorbate.
Each gram of Triamcinolone Acetonide Cream USP, 0.1% contains 1 mg
triamcinolone
acetonide USP in a cream base consisting of purified water,
emulsifying wax, mineral oil,
propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and
potassium sorbate.
Each gram of Triamcinolone Acetonide Cream USP, 0.5% contains 5 mg
triamcinolone
acetonide USP in a cream base consisting of purified water,
emulsifying wax, mineral oil,
propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and
potassium sorbate.
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
o