TRIAMCINOLONE ACETONIDE paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE - UNII:1ZK20VI6TY)

Available from:

Rebel Distributors Corp

INN (International Name):

TRIAMCINOLONE ACETONIDE

Composition:

TRIAMCINOLONE ACETONIDE 1 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Pediatric Use The safety and efficacy of Triamcinolone Acetonide Dental Paste USP, 0.1% in children is unknown. Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's Syndrome than mature patients because of a larger skin surface area to body weight ratio. Administration of corticosteroid-containing dental pastes to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere

Product summary:

Triamcinolone Acetonide Dental Paste USP, 0.1% Tubes containing 5 g of dental paste NDC 21695-641-05

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE PASTE
REBEL DISTRIBUTORS CORP
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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, 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 A
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 A .
PHARMACOKINETICS
The extent of absorption through the oral mucosa is determined by
multiple factors including the
vehicle, the integrity of the mucosal barrier, the duration of
therapy, and the presence of inflammation
and/or other disease processes. Once absorbed through the mucous
membranes, the disposition of
2
2
corticosteroids is similar to that of systemically administered
corticosteroids. Corticosteroids are
bound to the plasma proteins in varying degrees. Corticosteroids are
metabolized primarily in the liver
and are then excreted by the kidn