FLUOCINOLONE ACETONIDE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Taro Pharmaceuticals U.S.A., Inc.

Administration route:

TOPICAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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.

Product summary:

Fluocinolone Acetonide Topical Solution USP, 0.01% is available in 20 mL (NDC 51672-1365-2) and 60 mL (NDC 51672-1365-4) bottles. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Avoid excessive heat. Protect from freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

FLUOCINOLONE ACETONIDE- FLUOCINOLONE ACETONIDE SOLUTION
TARO PHARMACEUTICALS U.S.A., INC.
----------
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-11,21dihydroxy-16,17-[(1-methylethylidene)bis
(oxy)]-,(6α,11β,16α)-. It
has the following chemical structure:
Fluocinolone Acetonide 0.01% Solution (each mL contains 0.1 mg
Fluocinolone Acetonide) in a water-
washable base containing 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 systemically administered corticosteroids. Corticosteroids
are bound to plasma proteins in
varying degrees. Corticosteroids are metabolized primarily in the
liv