KOURZEQ- 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:

MidAmerica Pharmaceuticals

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

KOURZEQ 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:

KOURZEQ (triamcinolone acetonide dental paste USP, 0.1%) is supplied in tubes containing 5 g of dental paste NDC 82682-001-05 Storage Keep tightly closed. Store at 20° – 25° C (68° – 77° F) excursion permitted to 15° – 30° C (59° – 86° F) [See USP Controlled Room Temperature]. Distributed by: MidAmerica Pharmaceuticals, LLC Oak Park, IL 60301 Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02301 R0-10/22 KOURZEQTM is a trademark of MidAmerica Pharmaceuticals, LLC.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

KOURZEQ- TRIAMCINOLONE ACETONIDE PASTE
MIDAMERICA PHARMACEUTICALS
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KOURZEQ™
(TRIAMCINOLONE ACETONIDE DENTAL PASTE USP, 0.1%)
RX ONLY
DESCRIPTION
KOURZEQ (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 KOURZEQ 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 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 corticosteroids and