TRIAMCINOLONE ACETONIDE- triamcinolone acetonide ointment

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

NuCare Pharmaceuticals,Inc.

INN (International Name):

TRIAMCINOLONE ACETONIDE

Composition:

TRIAMCINOLONE ACETONIDE 1 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Triamcinolone Acetonide Ointment is 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.

Product summary:

Triamcinolone Acetonide Ointment USP, 0.1% is supplied in the following sizes: NDC 68071-1784-5 Bottles of 15g Store at 20° - 25°C (68° - 77°F). [see USP Controlled Room Temperature] Teligent Pharma, Inc. Buena, New Jersey 08310 Rev. 04/16

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE OINTMENT
NUCARE PHARMACEUTICALS,INC.
----------
TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.1%
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti- inflammatory
and antipruritic agents. The steroids in this class include
triamcinolone acetonide. Triamcinolone
acetonide is designated chemically as 9-Fluoro-11β, 16α,
17,21-tetrahydroxypregna-1,4-diene-3,20-
dione cyclic 16,17-acetal with acetone. C
H
FO
. M.W. 434.51; CAS Reg. No. 76-25-5.
Each gram of Triamcinolone Acetonide Ointment USP, 0.1% contains 1mg
triamcinolone acetonide in an
ointment base of light mineral oil and white petrolatum.
CLINICAL PHARMACOLOGY
Topicalcorticosteroids share anti- inflammatory, antipruritic 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 corticosteroidsis
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 handled
through pharmacokinetic pathways
similar to systemically administered corticosteroids. Corticosteroids
are bound to plasma proteins in
varying degrees.Corticosteroids are metaboliz