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

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Triamcinolone Acetonide - Triamcinolone Acetonide ointment prescribing information

Indications & Usage

INDICATIONS AND USAGE

Triamcinolone Acetonide Ointment 0.1% and 0.5% are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage & Administration

DOSAGE AND ADMINISTRATION

Apply a thin film of Triamcinolone Acetonide Ointment USP, 0.1% or 0.5%, as appropriate, to the affected area two to three times daily.

Occlusive Dressing Technique

Occlusive dressings may be used for the management of psoriasis or other recalcitrant conditions. Apply a thin film of ointment to the lesion, cover with a pliable nonporous film, and seal the edges. If needed, additional moisture may be provided by covering the lesion with a dampened clean cotton cloth before the nonporous film is applied or by briefly wetting the affected area with water immediately prior to applying the medication. The frequency of changing dressings is best determined on an individual basis. It may be convenient to apply triamcinolone acetonide ointment under an occlusive dressing in the evening and to remove the dressing in the morning (i.e., 12-hour occlusion). When utilizing the 12-hour occlusion regimen, additional ointment should be applied, without occlusion, during the day. Reapplication is essential at each dressing change.

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 preparations.

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 (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.

Description

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 USP is designated chemically as 9-Fluoro-11, 16, 17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Structural Formula:

Referenced Image

C 24 H 31 FO 6 , MW 434.50

Each gram of 0.1% and 0.5% Triamcinolone Acetonide Ointment USP contains 1 mg or 5 mg triamcinolone acetonide, respectively, in an ointment base of light mineral oil and white petrolatum.

Pharmacology

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 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 to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

How Supplied/Storage & Handling

HOW SUPPLIED

Triamcinolone Acetonide Ointment USP, 0.1% is available as follows:

  • 15 g tube NDC 68462-797-17
    80 g tube NDC 68462-797-49
    454 g jar NDC 68462-797-59

Triamcinolone Acetonide Ointment USP, 0.5% is available as follows:

  • 15 g tube NDC 68462-798-17

Storage

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

Manufactured by:
Glenmark Pharmaceuticals Limited
Village Kishanpura, Baddi Nalagarh Road,
District: Solan, Himachal Pradesh 173205, India

Manufactured for:
Glenmark Pharmaceuticals Inc., USA
Mahwah, NJ 07430

Questions? 1 (888)721-7115
www.glenmarkpharma.com/usa

December 2016

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