TRIAMCINOLONE ACETONIDE ointment

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Macleods Pharmaceuticals Limited

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Triamcinolone Acetonide Ointment is 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.

Produkt oversigt:

Triamcinolone Acetonide Ointment USP, 0.025% is available as follows: 15 gram tubes    NDC 33342-331-15 80 gram tubes    NDC 33342-331-80 454 g jar             NDC 33342-331-54 Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 gram tubes    NDC 33342-333-15 80 gram tubes    NDC 33342-333-80 454 g jar             NDC 33342-333-54 Triamcinolone Acetonide Ointment USP, 0.5% is available as follows: 15 gram tubes    NDC 33342-332-15 Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [See USP Controlled Room Temperature]. Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540 Manufacturer: Macleods Pharmaceuticals Limited At Oxalis Labs Baddi, Himachal Pradesh, INDIA To report SUSPECTED ADVERSE REACTIONS, contact Macleods Pharma USA, Inc.at 1-888-943-3210 or 1-855-926- 3384 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Revised: July 2023

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE OINTMENT
MACLEODS PHARMACEUTICALS LIMITED
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TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.025%, 0.1%, 0.5%
RX ONLY
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-
inflammatory and antipruritic agents. The steroids in this class
include triamcinolone
acetonide. Triamcinolone acetonide is designated chemically as
9-Fluoro-11β, 16α, 17,
21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with
acetone.
The structural formula is:
Each gram of Triamcinolone Acetonide Ointment USP, 0.025%, 0.1% or
0.5% contains
0.25 mg, 1 mg or 5 mg triamcinolone acetonide, respectively, in an
ointment base of
light mineral oil and white petrolatum.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritic 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 plasm