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:

VersaPharm Incorporated

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:

Topical corticosteroids are indicated for the 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 preparation.

Dettagli prodotto:

Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (NDC 61748-219-60). Triamcinolone Acetonide Lotion USP, 0.1% is supplied in the following size: 60 mL (NDC 61748-220-60). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. AVOID FREEZING SHAKE WELL BEFORE USING Rx only Manufactured by: Ei LLC   Kannapolis, NC 28083 Marketed by: VersaPharm Incorporated Marietta, GA 30062 IVP22060-00 Issued: 05-17-2013

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE LOTION
VERSAPHARM INCORPORATED
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TRIAMCINOLONE ACETONIDE LOTION, USP 0.025% AND 0.1%
RX ONLY
FOR TOPICAL USE ONLY
DESCRIPTION
Triamcinolone Acetonide Lotion, USP is supplied in the following
strengths: 0.025%, 0.1%. Each mL
of 0.025% and 0.1% Triamcinolone Acetonide Lotion provides 0.25 mg and
1 mg triamcinolone
acetonide, USP respectively, in a lotion base containing citric acid
anhydrous, cetyl alcohol,
simethicone, polysorbate 20, propylene glycol, purified water,
sorbitan monopalmitate and stearyl
alcohol.
Triamcinolone Acetonide is a topical corticosteroid known chemically
as 9-Fluoro-11β, 16α, 17, 21-
tetrahydroxypregna-1,4- diene-3,20-dione cyclic 16,17-acetal with
acetone.
The molecular formula is C
H FO . It has the following structure:
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 increases 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
24
31
6
similar to systemic