Country: United States
Language: English
Source: NLM (National Library of Medicine)
TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)
Rising Pharmaceuticals, Inc.
TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE 1 mg in 1 g
TOPICAL
PRESCRIPTION DRUG
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.
Triamcinolone Acetonide Dental Paste USP, 0.1% Tubes containing 5 g of dental paste NDC 64980-320-05
Abbreviated New Drug Application
TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE PASTE RISING PHARMACEUTICALS, INC. ---------- TRIAMCINOLONE ACETONIDE DENTAL PASTE USP, 0.1% RX ONLY DESCRIPTION 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. CLINICAL PHARMACOLOGY 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 A inhibitory proteins, collectively called lipocortins. It is postulatedthat these proteins control the biosynthesis of potent mediators ofinflammation such as prostaglandins and leukotrienes by inhibiting 2 therelease of their common precursor, arachidonic acid. Arachidonic acidis released from membrane phospholipids by phospholipase A . 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 Read the complete document