TRIAMCINOLONE ACETONIDE lotion

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Triamcinolone Acetonide (UNII: F446C597KA) (Triamcinolone Acetonide - UNII:F446C597KA)

Commercializzato da:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

INN (Nome Internazionale):

Triamcinolone Acetonide

Composizione:

Triamcinolone Acetonide 0.25 mg in 1 mL

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Triamcinolone Acetonide Lotion USP, 0.025% and 0.1% are indicated for relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

Dettagli prodotto:

Triamcinolone Acetonide Lotion USP, 0.025%; plastic squeeze bottles containing 60 mL     NDC 0168-0336-60 Triamcinolone Acetonide Lotion USP, 0.1%; plastic squeeze bottles containing 60 mL     NDC 0168-0337-60 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. AVOID FREEZING. SHAKE WELL BEFORE USING. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I2337D R05/15 #69

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE LOTION
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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TRIAMCINOLONE ACETONIDE LOTION USP, 0.025%, 0.1%
RX ONLY
DESCRIPTION:
Triamcinolone Acetonide USP is a topical corticosteroid designated
chemically as 9-Fluoro-
11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic
16,17-acetal with acetone.
Structural formula:
Each mL of 0.025% and 0.1% Triamcinolone Acetonide Lotion USP,
provides 0.25 mg and 1 mg
triamcinolone acetonide USP, respectively, in a lotion base containing
propylene glycol, cetyl alcohol,
stearyl alcohol, sorbitan monopalmitate, polysorbate 20, simethicone,
and purified water.
CLINICAL PHARMACOLOGY:
Topical corticosteroids share anti-inflammatory, anti-pruritic and
vasoconstrictive actions. The
mechanism of anti-inflammatory activity of the topical corticosteroids
is unclear. Various laboratory
methods, including vasoconstrictor assays, are used to compare and
predict potencies and/or clinical
efficacies of the topical corticosteroids. There is some evidence to
suggest that a recognizable
correlation exists between vasoconstrictor potency and therapeutic
efficacy in man.
PHARMACOKINETICS: The extent of percutaneous absorption of topical
corticosteroids is determined by
many factors including the vehicle, the integrity of the epidermal
barrier, and the use of occlusive
dressings.
Topical corticosteroids can be absorbed from normal intact skin.
Inflammation and/or other disease
processes in the skin increase percutaneous absorption. Occlusive
dressings substantially increase the
percutaneous absorption of topical corticosteroids. Thus, occlusive
dressings may be a valuable
therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE
AND ADMINISTRATION).
Once absorbed through the skin, topical corticosteroids are handled
through pharmacokinetic pathways
similar to systemically administered corticosteroids. Corticosteroids
are bound to plasma proteins in
varying degrees. Corticosteroids are metabolized primarily