TRIAMCINOLONE ACETONIDE- triamcinolone acetonide ointment usp, 0.05% ointment

Country: Amerika Syarikat

Bahasa: Inggeris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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

Boleh didapati daripada:

Encube Ethicals Private Limited

Laluan pentadbiran:

TOPICAL

Jenis preskripsi:

PRESCRIPTION DRUG

Tanda-tanda terapeutik:

Triamcinolone Acetonide Ointment 0.05% 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.

Ringkasan produk:

Triamcinolone Acetonide Ointment USP, 0.05%: jar containing 430 g (NDC 21922-024-11) KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.  You may report Side effects to FDA at 1-800-FDA-1088. You may also report side effects to Encube Ethicals Private Limited at (1-833-285-4151). DISPENSE IN A WELL-CLOSED CONTAINER CAUTION : Federal law prohibits dispensing without prescription. For external use only. Not for ophthalmic use. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Manufactured by: Encube Ethicals Pvt. Ltd. Plot No. C-1, Madkaim Industrial Estate, Madkaim, Post: Mardol, Ponda, Goa-403404, India. Distributed by: Encube Ethicals Inc. 200 Meredith Avenue, Suite101A Durham, NC 27713 USA. Revised : 04/2021

Status kebenaran:

Abbreviated New Drug Application

Ciri produk

TRIAMCINOLONE ACETONIDE - TRIAMCINOLONE ACETONIDE OINTMENT USP,
0.05% OINTMENT
ENCUBE ETHICALS PRIVATE LIMITED
----------
TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%
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.
Graphic Formula:
C
H
FO , MW 434.50
Each gram of 0.05% Triamcinolone Acetonide Ointment USP provides 0.5
mg of
Triamcinolone Acetonide in a water in-oil emulsion composed of light
mineral oil, purified
water, white petrolatum, mineral oil, ceresin wax 155/165, and lanolin
alcohols.
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.
24
31
6
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 sim