Fluocinonide Information
Fluocinonide () Description
The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and antipruritic agents. The topical corticosteroids are 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)]-,(6α, 11β, 16α)-. It has the following structural formula:
CHF0 M.W. 494.54
Each gram of Fluocinonide () Cream USP, 0.05% (Emulsified Base) contains: 0.5 mg Fluocinonide () in a water-washable aqueous emollient base of stearyl alcohol, cetyl alcohol, mineral oil, propylene glycol, sorbitan monostearate, polysorbate 60, citric acid (hydrous) and purified water.
Each gram of Fluocinonide () Cream USP, 0.05% contains: 0.5 mg Fluocinonide () in a specially formulated cream base consisting of stearyl alcohol, polyethylene glycol 8000, propylene glycol, 1,2,6-hexanetriol and citric acid (hydrous). This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties.
In this formulation, the active ingredient is totally in solution.
Each gram of Fluocinonide () Gel USP, 0.05% contains: 0.5 mg Fluocinonide () in a specifically formulated gel base consisting of purified water, propylene glycol, edetate disodium, carbomer 934P, and sodium hydroxide. Hydrochloric acid is added to adjust the pH. This clear, colorless thixotropic vehicle is greaseless, non-staining and completely water miscible.
In this formulation, the active ingredient is totally in solution.
Each gram of Fluocinonide () Ointment USP, 0.05% contains: 0.5 mg Fluocinonide () in an ointment base consisting of white petrolatum, castor oil, and sorbitan sesquioleate. It provides the occlusive and emollient effects desirable in an ointment.
In this formulation, the active ingredient is totally in solution.
Fluocinonide () 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.
Fluocinonide () Indications And Usage
The topical corticosteriods are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
Fluocinonide () Contraindications
The topical corticosteriods are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Fluocinonide () Precautions
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.
Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.
Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.
Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. (See ). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.
As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use.
In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.
The following tests may be helpful in evaluating the HPA axis suppression:
Urinary free cortisol test
ACTH stimulation test
Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.
Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.
Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.
Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in pediatric patients receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.
Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients.
Fluocinonide () 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:
Fluocinonide () Overdosage
Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects. (See ).
Fluocinonide () Dosage And Administration
The topical corticosteroids are 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.
Fluocinonide () How Supplied
Fluocinonide () Cream USP, 0.05% (Emulsified Base) is supplied in 15 gram, 30 gram, and 60 gram tubes.
Fluocinonide () Cream USP, 0.05% is supplied in 15 gram, 30 gram, and 60 gram tubes.
Fluocinonide () Gel USP, 0.05% is supplied in 60 gram tubes.
Fluocinonide () Ointment USP, 0.05% is supplied in 15 gram, 30 gram, and 60 gram tubes.
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature].
Avoid excessive heat, above 40°C (104°F).
Manufactured By:
Sellersville, PA 18960
Rev. K 3/2005
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