TRIAMCINOLONE ACETONIDE paste

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rising Pharmaceuticals, Inc.

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.

Product summary:

Triamcinolone Acetonide Dental Paste USP, 0.1% Tubes containing 5 g of dental paste NDC 64980-320-05

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE PASTE
RISING PHARMACEUTICALS, INC.
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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, 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