TRIAMCINOLONE ACETONIDE cream

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE - UNII:1ZK20VI6TY)

Tilgængelig fra:

H.J. Harkins Company, Inc.

INN (International Name):

TRIAMCINOLONE ACETONIDE

Sammensætning:

TRIAMCINOLONE ACETONIDE 1 mg in 1 g

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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.

Produkt oversigt:

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)

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE CREAM
H.J. HARKINS COMPANY, INC.
----------
TRIAMCINOLONE ACETONIDE, USP CREAM
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
_RX ONLY_
DESCRIPTION
The topical corticosteriods 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(0xy)]-,(11β,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 skin, topical corticosteroids are ha