TRIAMCINOLONE ACETONIDE- 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:

REMEDYREPACK INC.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 preparation.

Product summary:

Triamcinolone Acetonide Cream USP, 0.1% is supplied in the following sizes: 15 g tube                 (NDC: 52565-056-15) 30 g tube                 (NDC: 52565-056-30) 80 g tube                 (NDC: 52565-056-80) 1 lb jar (454 grams) (NDC: 52565-056-26) 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 PI-056-00 Rev 06/2019

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
REMEDYREPACK INC.
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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, 0.1% 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
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