TRIAMCINOLONE ACETONIDE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuitcals,Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Triamcinolone acetonide cream 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 preparation.

Product summary:

Triamcinolone Acetonide Cream USP, 0.1% is supplied in the following: NDC 68071-4168-8 Box of 80 g Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Revised: 04/2017

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
NUCARE PHARMACEUITCALS,INC.
----------
TRIAMCINOLONE ACETONIDE CREAM USP, 0.1%
RX ONLY
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 Cream USP contains Triamcinolone
Acetonide
[Pregna-1,4-diene-3,20-dione,
9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-
(oxy)]-, (11β,16α)-], with the empirical formula C
H
FO
and molecular weight
434.50. CAS 76-25-5.
Triamcinolone Acetonide Cream USP, 0.1% contains: 1 mg of
Triamcinolone Acetonide
per gram in a base containing Emulsifying Wax, Cetyl Alcohol,
Isopropyl Palmitate,
Sorbitol Solution, Glycerin, Lactic Acid, Benzyl Alcohol and Purified
Water.
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
24
31
6
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 p