Fluocinolone

Fluocinolone Acetonide Ointment USP,0.025% 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-dihydroxy16,17[(methylethylidene)bis(oxy)]-, (6α,11β,16α)-. It has the following chemical structure:

Fluocinolone Acetonide Ointment USP contains Fluocinolone acetonide 0.25 mg/g in a white petrolatum USP vehicle.

Topical corticosteroids share anti-inflammatory, antipruritc 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 the 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 Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

NDC 52565-013-60

Fluocinolone ACETONIDE
OINTMENT USP, 0.025%

60 grams
Rx ONLY

FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC USE