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Home > Medical Drugs > Drugs beginning with f > FLUOCINONIDE GEL USP, 0.05%
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FLUOCINONIDE GEL USP, 0.05%

Rx only

For External Use Only - Not for Ophthalmic Use

DESCRIPTION

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. Fluocinonide Gel contains fluocinonide USP (Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-, (6α,11β,16α)-). It has a molecular formula of C26H32F2O7 and a molecular weight of 494.53. It has the following structural formula:

Each gram contains: fluocinonide 0.5 mg in a gel base consisting of propylene glycol, propyl gallate, edetate disodium, and Carbopol 940 with sodium hydroxide and/or hydrochloric acid added to adjust the pH. This clear, colorless vehicle is greaseless, non-staining and completely water miscible. In this formulation, the active ingredient is totally in solution.

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.

INDICATIONS AND USAGE

Fluocinonide Gel is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

Fluocinonide Gel is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS

ADVERSE REACTIONS

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are uled in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, anceiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

DOSAGE AND ADMINISTRATION

Apply a thin film to the affected area two to four times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

Fluocinonide Gel USP, 0.05% in

15 gram tubes, NDC 0168-0135-15
60 gram tubes, NDC 0168-0135-60

Store at controlled room temperature 15°-30°C (59°-86°F).

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747

I213515A
R11/98
#60