TRIAMCINOLONE ACETONIDE lotion

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Cosette Pharmaceuticals, Inc.

INN (International Name):

Triamcinolone Acetonide

Sammensetning:

Triamcinolone Acetonide 1 mg in 1 mL

Administreringsrute:

TOPICAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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. 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. HPA axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Administration of topical corticosteroids to children should be limited

Produkt oppsummering:

Triamcinolone Acetonide Lotion, USP 0.1% is supplied in the following size: 60 mL. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. AVOID FREEZING. SHAKE WELL BEFORE USING Rx Only Distributed by: Cosette Pharmaceuticals, Inc, South Plainfield, NJ 07080 Iss. 02/2021 8-0676CPLNC1   VC7495

Autorisasjon status:

Abbreviated New Drug Application

Preparatomtale

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE LOTION
COSETTE PHARMACEUTICALS, INC.
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TRIAMCINOLONE ACETONIDE LOTION, USP 0.1%
RX ONLY
FOR TOPICAL USE ONLY
DESCRIPTION
Triamcinolone Acetonide Lotion, USP is supplied in the following
strength: 0.1%. Each mL
of Triamcinolone Acetonide Lotion, USP, 0.1%, contains 1 mg
triamcinolone acetonide,
USP in a lotion base containing citric acid, cetyl alcohol,
simethicone emulsion 30%,
polysorbate 20, propylene glycol, purified water, sorbitan
monopalmitate, and stearyl
alcohol.
Triamcinolone Acetonide is a topical corticosteroid known chemically
as 9-Fluoro-11β, 16
α, 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.
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31
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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 similar to systemically administered
corticosteroids.
Cortic