FLUOCINOLONE ACETONIDE - fluocinolone acetonide cream

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Cosette Pharmaceuticals, Inc.

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Fluocinolone Acetonide Cream 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 the components of the preparation.

Resumo do produto:

Fluocinolone Acetonide Cream USP, 0.025% is supplied in 15 g Tube - NDC 0713-0324-15 60 g Tube - NDC 0713-0324-60

Status de autorização:

New Drug Application

Características técnicas

FLUOCINOLONE ACETONIDE - FLUOCINOLONE ACETONIDE CREAM
COSETTE PHARMACEUTICALS, INC.
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FLUOCINOLONE ACETONIDE CREAM USP, 0.025%
RX ONLY
DESCRIPTION
Fluocinolone Acetonide Creatm 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)]-,(6ą,11ß,16ą)-. 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,
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.
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 pharmacokinetic pathwa