Get your patient on Fluocinonide - Fluocinonide gel (Fluocinonide)
Fluocinonide - Fluocinonide gel prescribing information
INDICATIONS AND USAGE
Fluocinonide Gel USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
DOSAGE AND ADMINISTRATION
Fluocinonide Gel USP, 0.05% is generally applied to the affected area as a thin film from 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.
CONTRAINDICATIONS
Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.
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 listed in an approximate decreasing order of occurrence:
Burning | Hypertrichosis | Maceration of the Skin |
Itching | Acneiform Eruptions | Secondary Infection |
Irritation | Hypopigmentation | Skin Atrophy |
Dryness | Perioral Dermatitis | Striae |
Folliculitis | Allergic Contact Dermatitis | Miliaria |
To report SUSPECTED ADVERSE REACTIONS , contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DESCRIPTION
Fluocinonide Gel USP, 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna-1,4-diene-3,20-dione,21-(acetyloxy)-6,9-difluoro-11-hydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(6a,11b,16a)-. It has the following chemical structure:
Mol. Formula: C 26 H 32 F 2 O 7
Mol. Wt: 494.53
Fluocinonide Gel USP, 0.05% contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 980, edetate disodium, propyl gallate, propylene glycol, sodium hydroxide (to adjust pH) and purified water. This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible. In the Fluocinonide Gel USP, 0.05% formulation, the active ingredient is totally in solution.
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 liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.
HOW SUPPLIED
Fluocinonide Gel USP, 0.05% is supplied in the following:
15 g (NDC 45802- 761 -15)
30 g (NDC 45802- 761 -30) and
60 g (NDC 45802- 761 -60) tubes.
Store at 20°- 25°C (68°- 77°F) [see USP Controlled Room Temperature]
Manufactured by Padagis®, Yeruham, Israel
www.padagis.com
Rev 08-24 7D000 RC PH2
