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:

A-S Medication Solutions

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 preparation.

Product summary:

Product: 50090-0163 NDC: 50090-0163-0 80 g in a TUBE

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE OINTMENT
A-S MEDICATION SOLUTIONS
----------
TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.025%, 0.1%
RX ONLY
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
Ointment USP contains
Triamcinolone Acetonide
[Pregna-1,4-diene-3,20-dione,9-fluoro-11,21-dihydroxy-16,17-
[(1-methylethylidene)bis-(oxy)]-, (11β,16α)-], with the molecular
formula C
H
FO and
molecular weight 434.51. CAS 76-25-5.
Triamcinolone Acetonide Ointment USP, 0.025% contains: 0.25 mg of
triamcinolone
acetonide per gram in a base containing white petrolatum and mineral
oil.
Triamcinolone Acetonide Ointment USP, 0.1% contains: 1 mg
triamcinolone acetonide
per gram in a base containing white petrolatum and mineral oil.
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
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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