Synalar (Fluocinolone Acetonide)

Generic Name

Fluocinolone Acetonide

Brand Names

Synalar, Flac, Dermotic, Derma-Smoothe, YUTIQ, Neo-Synalar, Iluvien, Retisert

FDA approval date: June 11, 1963

Classification: Corticosteroid

Form: Ointment, Cream, Oil, Implant, Solution

What is Synalar (Fluocinolone Acetonide)?

Fluocinolone Acetonide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Approved To Treat

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Brand Information

Synalar (fluocinolone acetonide)

1DESCRIPTION

SYNALAR

SYNALAR

2CLINICAL PHARMACOLOGY

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

2.1Pharmacokinetics

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

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 liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

3INDICATIONS AND USAGE

SYNALAR

4CONTRAINDICATIONS

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

5ADVERSE 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 listed in an approximate decreasing order of occurrence:

6OVERDOSAGE

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects

7DOSAGE AND ADMINISTRATION

SYNALAR

Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions. Some plastic films may be flammable and due care should be exercised in their use. Similarly, caution should be employed when such films are used on children or left in their proximity, to avoid the possibility of accidental suffocation.

If an infection develops, the use of the occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

8HOW SUPPLIED

SYNALAR

120 g Tube – NDC 43538-900-12

8.1STORAGE

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 Medimetriks Pharmaceuticals, Inc. at 1-973-882-7512 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.

9PRINCIPAL DISPLAY PANEL - 120 g Tube Carton

NDC 43538-900-12

SYNALAR^®
(fluocinolone acetonide)
Cream, 0.025%

For Topical Use Only
Not For Ophthalmic Use

120 g

MEDIMETRIKS
PHARMACEUTICALS, INC.