TRIAMCINOLONE ACETONIDE cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Proficient Rx LP

INN (International Name):

TRIAMCINOLONE ACETONIDE

Composition:

TRIAMCINOLONE ACETONIDE 1 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 Cream USP, 0.1% is available as follows: 15 g tube (NDC 63187-870-15) 80 g tube (NDC 63187-870-80)

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
PROFICIENT RX LP
----------
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 -
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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 cor