TRIAMCINOLONE ACETONIDE- triamcinolone acetonide lotion

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 0.25 mg in 1 mL

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 components of the preparation.

Product summary:

Triamcinolone Acetonide Lotion USP, 0.025% is supplied in the following size: 60 mL (60 grams) -  NDC 52565-010-59. Store at 20° to 25°C (68° to 77°F). [see USP Controlled Room Temperature]. AVOID FREEZING SHAKE WELL BEFORE USING

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE LOTION
TELIGENT PHARMA, INC.
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TRIAMCINOLONE ACETONIDE LOTION USP, 0.025%
RX ONLY
FOR DERMATOLOGIC USE ONLY
NOT FOR OPHTHALMIC USE
DESCRIPTION
Each mL of Triamcinolone Acetonide Lotion, USP, 0.025% contains 0.25
mg triamcinolone acetonide
in a lotion base containing cetyl alcohol, polysorbate 20, propylene
glycol, purified water, simethicone,
sorbitan monopalmitate, and stearyl alcohol.
Triamcinolone Acetonide is a topical corticosteroid known chemically
as 9-Fluoro-11β, 16α, 17, 21-
tetrahydroxypregna-1, 4-diene-3, 20-dione cyclic 16, 17-acetal with
acetone.
The molecular formula is C
H FO . It has the following structure:
M.W. 434.51
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritc 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 the 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 ar