TRIAMCINOLONE ACETONIDE cream

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

NuCare Pharmaceuticals,Inc.

INN (Medzinárodný Name):

TRIAMCINOLONE ACETONIDE

Zloženie:

TRIAMCINOLONE ACETONIDE 1 mg in 1 g

Spôsob podávania:

TOPICAL

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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.

Prehľad produktov:

Triamcinolone Acetonide Cream USP, 0.1% is available as follows: NDC 66267-933-80 Box of 80g

Stav Autorizácia:

Abbreviated New Drug Application

Súhrn charakteristických

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
NUCARE PHARMACEUTICALS,INC.
----------
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 skin, topical