TRIAMCINOLONE ACETONIDE paste

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

NuCare Pharmaceuticals,Inc.

INN (Tarptautinis Pavadinimas):

TRIAMCINOLONE ACETONIDE

Sudėtis:

TRIAMCINOLONE ACETONIDE 1 mg in 1 g

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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

Produkto santrauka:

Triamcinolone Acetonide Dental Paste USP, 0.1% Box containing 5 g of dental paste NDC 68071-1623-1

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE PASTE
NUCARE 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, 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
2
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 bound
to the plasma
proteins in varying degrees. Corticosteroids are metabolized primarily
in the liver and are
then excreted by the k