FLUOCINOLONE ACETONIDE solution

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Glasshouse Pharmaceuticals Limited Canada

投与経路:

TOPICAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Fluocinolone Acetonide Topical Solution USP, 0.01% 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.

製品概要:

Fluocinolone Acetonide Topical Solution USP, 0.01% is supplied in 60 mL bottles with applicator tip (NDC 71428-002-60). Store at room temperature 15°-25°C (59° - 77°F). Avoid freezing and excessive heat, above 40°C (104°F). To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch or Glasshouse Pharmaceuticals Limited Canada at 1-833-284-1788.

認証ステータス:

Abbreviated New Drug Application

製品の特徴

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE SOLUTION
GLASSHOUSE PHARMACEUTICALS LIMITED CANADA
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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
corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees.
Corticosteroids are
metabolized primari