TRIAMCINOLONE ACETONIDE paste

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Cosette Pharmaceuticals, Inc.

INN (International Name):

Triamcinolone Acetonide

Sammensætning:

Triamcinolone Acetonide 1 mg in 1 g

Indgivelsesvej:

DENTAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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.

Produkt oversigt:

Triamcinolone Acetonide Dental Paste, USP 0.1% is supplied in tubes containing 5 g of dental paste (NDC 0713-0655-40 ). Keep tightly closed. Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 Iss. 02/2021  8-0655CPLNC1   VC7479

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE PASTE
COSETTE 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 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
2
2
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 bound
to the plasma
proteins in varying degrees. Corticosteroids are metabolized primarily
in the liver and are
then excreted by the kidneys; some cortic