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Black Box Warning
Title
See full prescribing information for complete Boxed Warning.
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Content
Overview
Fluocinonide is a that is FDA approved for the {{{indicationType}}} of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Fluocinonide Cream USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.
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Dosing Information
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Off-Label Use and Dosage (Adult)
Guideline-Supported Use
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Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
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There is limited information regarding Off-Label Guideline-Supported Use of Fluocinonide in adult patients.
Non–Guideline-Supported Use
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Dosing Information
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There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluocinonide in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
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Dosing Information
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There is limited information regarding FDA-Labeled Use of Fluocinonide in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
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Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Fluocinonide in pediatric patients.
Non–Guideline-Supported Use
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Dosing Information
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Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Fluocinonide in pediatric patients.
Contraindications
Fluocinonide cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.
Warnings
Title
See full prescribing information for complete Boxed Warning.
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. 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.
Adverse Reactions
Clinical Trials Experience
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, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae, miliaria.
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Fluocinonide in the drug label.
Drug Interactions
There is limited information regarding Fluocinonide Drug Interactions in the drug label.
Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Fluocinonide in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Fluocinonide during labor and delivery.
Nursing Mothers
It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.
Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.
Geriatic Use
There is no FDA guidance on the use of Fluocinonide with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Fluocinonide with respect to specific gender populations.
Race
There is no FDA guidance on the use of Fluocinonide with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Fluocinonide in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Fluocinonide in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Fluocinonide in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Fluocinonide in patients who are immunocompromised.
Administration and Monitoring
Administration
Topical
Monitoring
There is limited information regarding Monitoring of Fluocinonide in the drug label.
IV Compatibility
There is limited information regarding IV Compatibility of Fluocinonide in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Topically applied corticosteroids can be absorbed in sufficient amount to produce systemic effects.
Chronic Overdose
There is limited information regarding Chronic Overdose of Fluocinonide in the drug label.
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 the therapeutic efficacy in man.
Structure
Fluocinonide Cream 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)]-, (6ą,11ß,16ą). Its molecular formula is C26H32F2O7, and has the molecular weight of 494.53. It has the following chemical structure:
Fluocinonide Cream USP, 0.05% contains fluocinonide 0.5 mg/g in a cream base consisting of citric acid, 1,2,6-hexanetriol, polyethylene glycol-8000, propylene glycol and stearyl alcohol. This white cream vehicle is greaseless, non-staining, anhydrous and completely water miscible. The base provides emollient and hydrophilic properties.
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Fluocinonide in the drug label.
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.
Nonclinical Toxicology
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.
Clinical Studies
There is limited information regarding Clinical Studies of Fluocinonide in the drug label.
How Supplied
Storage
There is limited information regarding Fluocinonide Storage in the drug label.
Images
Drug Images
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Patients using topical corticosteroids should receive the following information and instructions:
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
Patients should report any signs of local adverse reactions especially under occlusive dressing.
Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.
Precautions with Alcohol
Alcohol-Fluocinonide interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
