FLUOCINOLONE ACETONIDE solution

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Marlex Pharmaceuticals Inc

Mode d'administration:

TOPICAL

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Fluocinolone Acetonide Topical Solution USP, 0 .0 1 % 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.

Descriptif du produit:

Fluocinolone Acetonide Topical Solution USP, 0.01 % is supplied in 60 mL bottles with applicator tip (NDC 10135-0670-61).

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE SOLUTION
MARLEX PHARMACEUTICALS INC
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FLUOCINOLONE ACETONIDE
FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE SOLUTION
MARLEX PHARMACEUTICALS, INC.
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FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% RX ONLY
DESCRIPTION
Fluocinolone Acetonide Topical Solution USP, 0.01 % 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 Topical Solution USP, 0 .01 % contains
fluocinolone acetonide 0.1
mg/mL in a water-washable base of citric acid and propylene glycol.
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 pathways similar to systematically administered
corticost