Triamcinolone Acetonide, Dental Paste USP, 0.1%

DESCRIPTION

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displayName: DESCRIPTION SECTION
FDA Article Code: 34089-3

Triamcinolone Acetonide Dental Paste USP, 0.1%, contains the corticosteroid triamcinolone acetonide in an adhesive vehicle suitable for application to oral tissues. Triamcinolone acetonide is designated chemically as 9-fluoro-11β, 16α, 17, 21-tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with acetone. The structural formula of triamcinolone acetonide is as follows:

Each gram of triamcinolone acetonide dental paste contains 1 mg triamcinolone acetonide in an emollient dental paste containing carboxymethylcellulose sodium, gelatin, and pectin in a plasticized hydrocarbon gel (a polyethylene and mineral oil gel base).

CLINICAL PHARMACOLOGY

id: f4ef4792-9a2a-4e0b-b896-d50f1b493190
displayName: CLINICAL PHARMACOLOGY SECTION
FDA Article Code: 34090-1

Like other topical corticosteroids, triamcinolone acetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A₂ inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor, arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A₂.

INDICATIONS AND USAGE

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displayName: INDICATIONS & USAGE SECTION
FDA Article Code: 34067-9

Triamcinolone Acetonide Dental Paste USP, 0.1% is indicated for adjunctive treatment and for the temporary relief of symptoms associated with oral inflammatory lesions and ulcerative lesions resulting from trauma.

CONTRAINDICATIONS

id: fdd051e0-065c-4122-b0ba-c4e80c06874e
displayName: CONTRAINDICATIONS SECTION
FDA Article Code: 34070-3

Triamcinolone acetonide dental paste is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation; it is also contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.

ADVERSE REACTIONS

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displayName: ADVERSE REACTIONS SECTION
FDA Article Code: 34084-4

The following local adverse reactions may occur with corticosteroid-containing dental pastes: burning, itching, irritation, dryness, blistering or peeling not present prior to therapy, perioral dermatitis, allergic contact dermatitis, maceration of the oral mucosa, secondary infection, and atrophy of the oral mucosa. Also, see PRECAUTIONS for potential effects of systemic absorption.

DOSAGE AND ADMINISTRATION

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displayName: DOSAGE & ADMINISTRATION SECTION
FDA Article Code: 34068-7

Press a small dab (about 1/4 inch) to the lesion until a thin film develops. A larger quantity may be required for coverage of some lesions. For optimal results use only enough to coat the lesion with a thin film. Do not rub in. Attempting to spread this preparation may result in granular, gritty sensation and cause it to crumble. After application, however, a smooth, slippery film develops. The preparation should be applied at bedtime to permit steroid contact with the lesion throughout the night. Depending on the severity of symptoms, it may be necessary to apply the preparation two or three times a day, preferably after meals. If significant repair or regeneration has not occurred in seven days, further investigation is advisable.

HOW SUPPLIED

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displayName: HOW SUPPLIED SECTION
FDA Article Code: 34069-5

Triamcinolone Acetonide Dental Paste USP, 0.1% is supplied in tubes containing 5 g of dental paste (NDC 51672–1267-5) and 7.5 g of dental paste (NDC 51672-1267-8).

PRINCIPAL DISPLAY PANEL – 7.5 g Tube Carton

id: 16f8ded7-5b98-4448-92af-0f2555ed6ea1
displayName: PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA Article Code: 51945-4

NDC 51672-1267-8 7.5 g Triamcinolone Acetonide
Dental Paste USP, 0.1% FOR TOPICAL USE IN ADJUNCTIVE TREATMENT OF ORAL LESIONS Rx only TARO Keep this and all medications out of the reach of children.