FLUOCINOLONE ACETONIDE cream

País: Estats Units

Idioma: anglès

Font: NLM (National Library of Medicine)

ingredients actius:

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

Disponible des:

Teligent Pharma, Inc.

Designació comuna internacional (DCI):

Fluocinolone Acetonide

Composición:

Fluocinolone Acetonide 0.1 mg in 1 g

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

Fluocinolone Acetonide Cream 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.

Resumen del producto:

Fluocinolone Acetonide Cream USP, 0.01% is supplied in Fluocinolone Acetonide Cream USP, 0.025% is supplied in Store at room temperature 15-25°C (59-77°F); avoid freezing and excessive heat above 40°C (104°F).

Estat d'Autorització:

New Drug Application Authorized Generic

Fitxa tècnica

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE CREAM
TELIGENT PHARMA, INC.
----------
FLUOCINOLONE ACETONIDE
CREAM USP, 0.01%, 0.025%
FOR INITIATION OF THERAPY IN INFLAMMATORY DERMATOSES.
RX ONLY
DESCRIPTION
Fluocinolone Acetonide Cream USP 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 0.01% contains fluocinolone acetonide
0.1 mg/g in a water-
washable aqueous base of butylated hydroxytoluene, cetyl alcohol,
citric acid, edetate disodium,
methylparaben and propylparaben (preservatives), mineral oil, polyoxyl
20 cetostearyl ether, propylene
glycol, simethicone, stearyl alcohol, water (purified) and white wax.
Fluocinolone Acetonide Cream USP 0.025% contains fluocinolone
acetonide 0.25 mg/g in a water-
washable aqueous base of butylated hydroxytoluene, cetyl alcohol,
citric acid, edetate disodium,
methylparaben and propylparaben (preservatives), mineral oil, polyoxyl
20 cetostearyl ether, propylene
glycol, simethicone, stearyl alcohol, water (purified) 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.
Inflammati