FLUOCINOLONE ACETONIDE cream

Страна: САЩ

Език: английски

Източник: NLM (National Library of Medicine)

Активна съставка:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)

Предлага се от:

Cosette Pharmaceuticals, Inc.

Начин на приложение:

TOPICAL

Вид предписание :

PRESCRIPTION DRUG

Терапевтични показания:

Fluocinolone Acetonide Cream, USP is indicated for the relief of the inflammatory and pruritic mani­festations of corticosteriod-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Каталог на резюме:

Fluocinolone Acetonide Cream, USP, 0.025% is supplied as follows: 15 g Tube – NDC 0713-0709-15 60 g Tube – NDC 0713-0709-60

Статус Оторизация:

Abbreviated New Drug Application

Данни за продукта

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE CREAM
COSETTE PHARMACEUTICALS, INC.
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FLUOCINOLONE ACETONIDE CREAM, USP 0.025%
RX ONLY
DESCRIPTION
Fluocinolone Acetonide Cream, USP 0.025% 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-dihydroxy-16,17-[(1-
methylethylidene)bis (oxy)]-,(6α,11β,16α)-. It has the following
chemical structure:
Fluocinolone Acetonide Cream, USP contains fluocinolone acetonide 0.25
mg/g in a
water-washable aqueous base of butylated hydroxytoluene, cetyl
alcohol, citric acid
anhydrous, edetate disodium, methylparaben and propylparaben
(preservatives),
mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified
water, simethicone
emulsion, stearyl alcohol, and white wax.
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 through the skin, topical corticosteroids are handled
through
pharm