Rx only

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 USP, 0.1% contains 1 mg triamcinolone acetonide in a dental paste containing gelatin, pectin, cream flavor, vanilla flavor and carboxymethylcellulose sodium in Plasticized Hydrocarbon Gel, a polyethylene and mineral oil gel base.

Like other topical corticosteroids, triamcinoloneacetonide has anti-inflammatory, antipruritic, and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of thetopical steroids, in general, is unclear. However, corticosteroids arethought to act by the induction of phospholipase A2inhibitory proteins, collectively called lipocortins. It is postulatedthat these proteins control the biosynthesis of potent mediators ofinflammation such as prostaglandins and leukotrienes by inhibiting therelease of their common precursor, arachidonic acid. Arachidonic acidis released from membrane phospholipids by phospholipase A2.

Pharmacokinetics

The extent of absorption through the oral mucosa isdetermined by multiple factors including the vehicle, the integrity ofthe mucosal barrier, the duration of therapy, and the presence ofinflammation and/or other disease processes. Once absorbed through themucous membranes, the disposition of corticosteroids is similar to thatof systemically administered corticosteroids. Corticosteroids are boundto the plasma proteins in varying degrees. Corticosteroids aremetabolized primarily in the liver and are then excreted by thekidneys; some corticosteroids and their metabolites are also excretedinto the bile.

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.

Triamcinolone Acetonide Dental Paste USP, 0.1% is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations; it is also contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.

General:

Triamcinolone Acetonide Dental Paste USP, 0.1% may cause local adverse reactions. If irritation develops, Triamcinolone Acetonide Dental Paste USP, 0.1% should be discontinued and appropriate therapy instituted. Allergic contact sensitization with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.

If concomitant mucosal infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Triamcinolone Acetonide Dental Paste USP, 0.1% should be discontinued until the infection has been adequately controlled.

If significant regeneration or repair of oral tissues has not occurred in seven days, additional investigation into the etiology of the oral lesion is advised.

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, glucosuria, and other adverse effects known to occur with parenterally-administered steroid preparations; therefore, it may be advisable to periodically evaluate patients on prolonged therapy with corticosteroid-containing dental pastes for evidence of HPA axis suppression (see PRECAUTIONS,Laboratory Tests). If HPA axis suppression is noted, an attempt should be made to withdraw the drug or to reduce the frequency of application. Recovery of HPA axis function is generally prompt and complete upon discontinuation of therapy.

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.

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.

Triamcinolone Acetonide Dental Paste USP, 0.1%

Tubes containing 5 g of dental paste

NDC 64980-320-05

Storage

Keep tightly closed. Store at 20° - 25° C (68° - 77° F) excursion permitted to 15° - 30° C (59° - 86° F) [See USP Controlled Room Temperature].



Distributed by:

Rising Pharmaceuticals, Inc.

Saddle Brook, NJ 07663



Manufactured by:

Lyne Laboratories, Inc.

Brockton, MA 02301



R6-09/21

Rising® NDC 64980-320-05

Triamcinolone Acetonide

Dental Paste USP, 0.1%

Rx only

5g Read all sides