TRIAMCINOLONE ACETONIDE ointment

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Lake Erie Medical DBA Quality Care Products LLC

INN (Nome Internazionale):

TRIAMCINOLONE ACETONIDE

Composizione:

TRIAMCINOLONE ACETONIDE 1 mg in 1 g

Via di somministrazione:

TOPICAL

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

Triamcinolone Acetonide Ointment USP, 0.025% is available as follows: Triamcinolone Acetonide Ointment USP, 0.1% is available as follows: 15 gram tubes                NDC 49999-216-15 Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. E. FOUGERA & CO. A division of Fougera PHARMACEUTICALS INC. Melville, New York 11747 I20515K/IF20515K R05/13 #221

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

TRIAMCINOLONE ACETONIDE- TRIAMCINOLONE ACETONIDE OINTMENT
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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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 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 thr