FLUOCINOLONE ACETONIDE solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

fluocinolone acetonide (UNII: 0CD5FD6S2M) (fluocinolone acetonide - UNII:0CD5FD6S2M)

Disponível em:

Fougera Pharmaceuticals Inc.

Via de administração:

TOPICAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 the components of the preparation.

Resumo do produto:

Fluocinolone Acetonide Topical Solution USP, 0.01% in 60 mL bottles, NDC 0168-0059-60. Store at controlled room temperature 15° to 30°C (59° to 86°F). Avoid excessive heat. Protect from freezing. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I259E R10/12 #348

Status de autorização:

Abbreviated New Drug Application

Características técnicas

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE SOLUTION
FOUGERA PHARMACEUTICALS INC.
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FLUOCINOLONE ACETONIDE TOPICAL
SOLUTION USP, 0.01%
FOR DERMATOLOGIC USE ONLY.
NOT FOR OPHTHALMIC USE.
RX ONLY
DESCRIPTION:
Fluocinolone Acetonide Topical Solution USP, 0.01% contains
fluocinolone acetonide USP (Pregna-
1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,
(6α,11β,16α)-); it has an empirical formula of C
H F O and a molecular weight of 425.49.
Each mL of the topical solution contains 0.1 mg fluocinolone acetonide
in a water-washable base
containing propylene glycol and citric acid.
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 the 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 pathways similar to systemically administered
corticosteroids. Corticosteroids are
bound to plasma proteins in varying degrees. Corticosteroids are
metabolized primarily in the liver and
24
30
2
6
are then exc