Get your patient on Triamcinolone Acetonide - Triamcinolone Acetonide lotion (Triamcinolone Acetonide)

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Triamcinolone Acetonide - Triamcinolone Acetonide lotion prescribing information

Indications & Usage

INDICATIONS AND USAGE

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

DOSAGE AND ADMINISTRATION

Topical corticosteroids are generally applied to the affected area as a thin film from three to four times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Contraindications

CONTRAINDICATIONS

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Adverse Reactions

ADVERSE REACTIONS

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc. at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Description

DESCRIPTION

Triamcinolone Acetonide Lotion, USP is supplied in the following strength: 0.1%. Each mL of Triamcinolone Acetonide Lotion, USP, 0.1%, contains 1 mg triamcinolone acetonide, USP in a lotion base containing citric acid, cetyl alcohol, simethicone emulsion 30%, polysorbate 20, propylene glycol, purified water, sorbitan monopalmitate, and stearyl alcohol.

Triamcinolone Acetonide is a topical corticosteroid known chemically as 9-Fluoro-11β, 16 α, 17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone.

The molecular formula is C 24 H 31 FO 6 . It has the following structure.

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Pharmacology

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.

How Supplied/Storage & Handling

HOW SUPPLIED

Triamcinolone Acetonide Lotion, USP 0.1% is supplied in the following size: 60 mL.



Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

AVOID FREEZING.

SHAKE WELL BEFORE USING

Rx Only


Distributed by:
Cosette Pharmaceuticals, Inc,
South Plainfield, NJ 07080

Iss. 02/2021
8-0676CPLNC1   VC7495

Data SourceWe receive information directly from the FDA and PrescriberPoint is updated as frequently as changes are made available
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