FLUOCINOLONE ACETONIDE solution

Maa: Yhdysvallat

Kieli: englanti

Lähde: NLM (National Library of Medicine)

Aktiivinen ainesosa:

Fluocinolone Acetonide (UNII: 0CD5FD6S2M) (Fluocinolone Acetonide - UNII:0CD5FD6S2M)

Saatavilla:

Teligent Pharma, Inc.

Antoreitti:

TOPICAL

Prescription tyyppi:

PRESCRIPTION DRUG

Käyttöaiheet:

Fluocinolone Acetonide Topical Solution 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 components of the preparation.

Tuoteyhteenveto:

Fluocinolone Acetonide Topical Solution 0.1%:   60 mL Bottle with applicator tip - NDC 52565-012-59 Store at room temperature 15° to 25°C (59° to 77°F); avoid freezing and excessive heat above 40°C (104°F). Teligent Pharma, Inc. Buena, New Jersey 08310 C100856 Revised: 06/2018

Valtuutuksen tilan:

New Drug Application Authorized Generic

Valmisteyhteenveto

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE SOLUTION
TELIGENT PHARMA, INC.
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FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%
RX ONLY
DESCRIPTION
Fluocinolone Acetonide Topical Solution USP, 0.01% is intended for
topical administration. The active
component is the corticosteroid fluocinolone acetonide, which has the
chemical name pregna-1,4-
diene-3,20-dione,6,9-difluoro-11,21-dihydroxy16,17[(methylethylidene)bis(oxy)]-,
(6α,11β,16α)-. It has
the following chemical structure:
Fluocinolone Acetonide Solution USP contains fluocinolone acetonide
0.1 mg/mL in a water-washable
base of citric acid and propylene glycol.
CLINICAL PHARMACOLOGY
Topical corticosteroids share anti-inflammatory, antipruritc 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 the 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 plasma proteins in
varying degrees. Corticosteroids are metabolized primarily in the
liver and are then excreted by the
k