Synalar
(fluocinolone acetonide)Synalar Prescribing Information
Fluocinolone acetonide topical solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteriod-responsive dermatoses.
Fluocinolone acetonide topical solution is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion.
Occlusive dressing 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.
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
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:
Burning | Perioral dermatitis |
| Itching | Allergic contact dermatitis |
| Irritation | Maceration of the skin |
| Dryness | Secondary infection |
| Folliculitis | Skin atrophy |
Hypertrichosis | Striae |
| Acneiform eruptions | Miliaria |
| Hypopigmentation |
To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-800-272-5525 or FDA at 1-800-FDA-1088 or www.fda/gov/medwatch.
Fluocinolone acetonide topical solution, USP 0.01% is intended for topical administration. The active component is the corticosteroid fluocinolone acetonide, USP, 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 contains fluocinolone acetonide, USP (anhydrous) 0.1 mg/mL in a water-washable base of citric acid anhydrous and propylene glycol.
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 liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
Fluocinolone Acetonide) Topical Solution, 0.01%
60 mL Bottle with applicator tip – NDC 0591-2990-60
STORAGE
Store at room temperature 15° to 25°C (59° to 77°F); avoid freezing and excessive heat above 40°C (104°F).
Manufactured by:
Actavis Laboratories UT, Inc.
Salt Lake City, UT 84108 USA
Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA
234192-00
Revised – August 2016