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:

Cosette Pharmaceuticals, Inc.

INN (International Name):

Triamcinolone Acetonide

Composition:

Triamcinolone Acetonide 0.25 mg in 1 g

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Triamcinolone Acetonide Ointment USP, 0.025% is available as follows: 15 g tube (NDC 0713-0229-15) 80 g tube (NDC 0713-0229-80) Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 g tube (NDC 0713-0228-15) 80 g tube (NDC 0713-0228-80)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE OINTMENT
COSETTE PHARMACEUTICALS, INC.
----------
TRIAMCINOLONE ACETONIDE OINTMENT USP
FOR EXTERNAL 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,16ą)-. C
H
FO , M.W. 434.51; CAS Reg. No. 76-25-
5.
Each gram of Triamcinolone Acetonide Ointment USP, 0.025% or 0.1%
contains 0.25 mg
or 1 mg triamcinolone acetonide USP, respectively, in an ointment base
consisting of
light mineral oil NF and white petrolatum USP.
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.
24
31
6
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 t