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:

Teligent Pharma, Inc.

INN (International Name):

Triamcinolone Acetonide

Composition:

Triamcinolone Acetonide 5 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, 0.5% is available as follows: 15 g tube (NDC 52565-048-15)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE OINTMENT
TELIGENT PHARMA, INC.
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TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.5%
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
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 9-fluoro-11b, 16a,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, 0.5% contains 5 mg
triamcinolone acetonide,
respectively, in an ointment base of light mineral oil and white
petrolatum.
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 handled through
pharmacokinetic pathways similar to
systemically administered corticosteroids. Corticosteroids are bound
to plasma proteins in varying
degrees. Corticosteroids are metabolized