TRIAMCINOLONE ACETONIDE cream TRIAMCINOLONE ACETONIDE ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

DIRECTRX

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Triamcinolone Acetonide Cream USP, 0.025% Triamcinolone Acetonide Cream USP, 0.1% 15 gram tubes NDC 0168-0003-15 15 gram tubes NDC 0168-0004-15 80 gram tubes NDC 0168-0003-80 80 gram tubes NDC 0168-0004-80 1 Lb jars NDC 0168-0004-16 Triamcinolone Acetonide Cream USP, 0.5% 15 gram tubes NDC 0168-0002-15. Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. Fougera PHARMACEUTICALS INC. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville New York 11747 I20215G/IF20215G R09/11 #227 46165001A R06/15 #65

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE OINTMENT
DIRECTRX
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TRIAMCINOLONE ACETONIDE 0.1% 15G
Rx only
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 C24H31FO6 and molecular weight 434.50. CAS 76-25-5.
[chemstructure]
Triamcinolone Acetonide Cream USP, 0.025% contains: 0.25 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.
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.
Triamcinolone Acetonide Cream USP, 0.5% contains: 5 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.
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 su