FLUOCINOLONE ACETONIDE ointment

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.

Designación común internacional (DCI):

fluocinolone acetonide

Composición:

fluocinolone acetonide 0.25 mg in 1 g

Vía de administración:

TOPICAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 Ointment USP, 0.025% 15 gram tubes, NDC 0168-0064-15 60 gram tubes, NDC 0168-0064-60 Store at controlled room temperature 15°-30°C (59°-86°F). Avoid excessive heat. Protect from freezing. E. FOUGERA & CO. A division of Fougera Pharmaceuticals Inc. Melville, New York 11747 I26415G R11/12 #296

Estado de Autorización:

Abbreviated New Drug Application

Ficha técnica

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE OINTMENT
E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.
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FLUOCINOLONE ACETONIDE OINTMENT, USP, 0.025%
FOR TOPICAL USE ONLY. NOT FOR OPHTHALMIC USE.
RX ONLY
DESCRIPTION:
Fluocinolone Acetonide Ointment 0.025% is intended for topical
administration. The active component
is the corticosteroid 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 452.49 (CAS Registry Number 67-73-2).
Each gram of the ointment contains 0.25 mg Fluocinolone Acetonide in a
base containing White
Petrolatum.
CLINICAL PHARMACOLOGY:
Topical corticosteroids share anti-inflammatory, antipruritic 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
24
30
2
6
pharmacokinetic pathways similar to systemically administered
corticosteroids. Corticosteroids are
bound to plasma proteins in varying degrees.