TRIAMCINOLONE ACETONIDE cream

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Nusipirk tai dabar

Parsisiųsti Prekės savybės (SPC)
20-01-2016

Veiklioji medžiaga:

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

Prieinama:

Central Texas Community Health Centers

INN (Tarptautinis Pavadinimas):

TRIAMCINOLONE ACETONIDE

Sudėtis:

TRIAMCINOLONE ACETONIDE 1 mg in 1 g

Vartojimo būdas:

TOPICAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

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 preparations.

Produkto santrauka:

Triamcinolone Acetonide Cream USP, 0.025% is available as follows: 15 g tube (NDC 45802-063 -35) 80 g tube (NDC 45802-063 -36) 454 g jar (NDC 45802-063 -05) Triamcinolone Acetonide Cream USP, 0.1% is available as follows: 15 g tube (NDC 45802-064 -35) 80 g tube (NDC 45802-064 -36) 454 g jar (NDC 45802-064 -05) Triamcinolone Acetonide Cream USP, 0.5% is available as follows: 15 g tube (NDC 45802-065 -35)

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

                                TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
CENTRAL TEXAS COMMUNITY HEALTH CENTERS
----------
TRIAMCINOLONE ACETONIDE CREAM USP, 0.025%, 0.1%, 0.5%
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
RX ONLY
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-inflammatory
and anti-pruritic agents. Triamcinolone acetonide is designated
chemically as pregna-1,4-diene-3,20-
dione,9-fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene) bis
(oxy)]-,(11ß,16α)-. C
H FO , and
M.W. of 434.51; CAS Reg. No. 76-25-5.
Each gram of 0.025%, 0.1% and 0.5% Triamcinolone Acetonide Cream USP
contains 0.25 mg, 1 mg, or
5 mg triamcinolone acetonide respectively, in a washable cream base of
cetyl alcohol, cetyl esters wax,
glycerin, glyceryl monostearate, isopropyl palmitate, polysorbate-60,
propylene glycol, purified water,
sorbic acid, and sorbitan monostearate.
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 ski
                                
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