TRIAMCINOLONE ACETONIDE cream

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

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Produktets egenskaber Produktets egenskaber (SPC)
01-06-2023

Aktiv bestanddel:

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

Tilgængelig fra:

Proficient Rx LP

Indgivelsesvej:

TOPICAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Triamcinolone acetonide cream is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.  Triamcinolone acetonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Produkt oversigt:

Triamcinolone acetonide cream USP 0.1% is supplied in 15 g tube NDC 63187-025-15 30 g tube NDC 63187-025-30 80 g tube NDC 63187-025-80 Store at 20-25°C (68°-77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing. PRINTED IN USA Manufactured for:  Ascend Laboratories, LLC Montvale, NJ 07645 Manufactured by: Crown Laboratories, Inc. Johnson City, TN 37604 Relabeled by: Proficient Rx LP Thousand Oaks, CA 91320 P1810.01 Revised: Sept 2015

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

                                TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE CREAM
PROFICIENT RX LP
----------
(TRIAMCINOLONE ACETONIDE CREAM USP) 0.1%
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-
inflammatory and antipruritic agents. Triamcinolone acetonide is a
member of this class.
Chemically triamcinolone acetonide is pregna-1, 4-diene-3, 20-dione,
9-flouro-11, 21-
dihydroxy-16, 17-[(1-methylethylidene)bis(oxy)]-(11β16a). Its
structural formula is:
Each gram of Triamcinolone Acetonide Cream USP, 0.025 % contains 0.25
mg triamcinolone acetonide USP in a cream base consisting of purified
water,
emulsifying wax, mineral oil, propylene glycol, sorbitol solution,
cetyl palmitate, sorbic
acid, and potassium sorbate.
Each gram of Triamcinolone Acetonide Cream USP, 0.1 % contains 1 mg
triamcinolone
acetonide USP in a cream base consisting of purified water,
emulsifying wax, mineral oil,
propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and
potassium sorbate.
Each gram of Triamcinolone Acetonide Cream USP, 0.5 % contains 5 mg
triamcinolone
acetonide USP in a cream base consisting of purified water,
emulsifying wax, mineral oil,
propylene glycol, sorbitol solution, cetyl palmitate, sorbic acid, and
potassium sorbate.
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 in
                                
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