TRIAMCINOLONE ACETONIDE paste

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Versapharm Incorporated

Verabreichungsweg:

DENTAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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 preparation; it is also contraindicated in the presence of fungal, viral, or bacterial infections of the mouth or throat.

Produktbesonderheiten:

Triamcinolone acetonide dental paste USP, 0.1% is supplied in tubes containing 5 g of dental paste (NDC 61748-210-05). Keep tightly closed. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature].

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE PASTE
VERSAPHARM INCORPORATED
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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
an emollient dental paste containing gelatin, pectin, and
carboxymethylcellulose sodium in a 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
corticosteroids is similar to that of systemically administered
corticosteroids. Corticosteroids are
2
2
bound to the plasma proteins in varying degrees. Corticosteroids are
metabolized primarily in the liver
and are then excreted by the kidneys; some c