FLUOCINOLONE ACETONIDE cream FLUOCINOLONE ACETONIDE ointment

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

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

Mevcut itibaren:

Cosette Pharmaceuticals, Inc.

INN (International Adı):

Fluocinolone Acetonide

Kompozisyon:

Fluocinolone Acetonide 0.25 mg in 1 g

Uygulama yolu:

TOPICAL

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

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.

Ürün özeti:

Fluocinolone Acetonide Cream, USP 0.01% is supplied in: 15 g tubes NDC 0713-0223-15, and 60 g tubes NDC 0713-0223-60 Fluocinolone Acetonide Ointment, USP 0.025% USP is supplied in: 15 g tubes NDC 0713-0224-15, and 60 g tubes NDC 0713-0224-60 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Distributed by: Cosette Pharmaceuticals, Inc. South Plainfield, NJ 07080 VC7669 Rev. 09/2022         8-FLUOCPLNC3

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE CREAM
FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OINTMENT
COSETTE PHARMACEUTICALS, INC.
----------
FLUOCINOLONE ACETONIDE CREAM, USP 0.01%
FLUOCINOLONE ACETONIDE CREAM, USP 0.025%
FLUOCINOLONE ACETONIDE OINTMENT, USP 0.025%
TOPICAL CORTICOSTEROID
DESCRIPTION
The topical corticosteroids constitute a class of primarily synthetic
steroids used as anti-
inflammatory and anti-pruritic agents. Fluocinolone Acetonide is
included in this class of
synthetic corticosteroids.
Chemically Fluocinolone Acetonide is Pregna-1,4-diene-3,20-dione,
6,9-difluoro-11,21-
dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α, 11β, 6α)-),
with the molecular
formula C
H
F
0
, a molecular weight of 452.49 and the following structural
formula:
Each gram of Fluocinolone Acetonide Cream, USP 0.01% contains 0.1 mg
fluocinolone
acetonide USP in a water washable cream base consisting of mineral oil
(and) lanolin
alcohols, isopropyl palmitate NF, propylene glycol stearate, cetyl
alcohol NF, sorbitan
monostearate NF, polysorbate 60 NF, sorbic acid NF, polyoxyl (40)
stearate NF, purified
water USP, propylene glycol USP with propylparaben NF and
methylparaben NF as
preservatives.
Each gram of Fluocinolone Acetonide Ointment, USP 0.025% contains 0.25
mg of
fluocinolone acetonide USP in an ointment base consisting of light
mineral oil NF and
white petrolatum USP.
24
30
2
6
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