Fluocinonide is a synthetic, high-potency, fluorinated topical corticosteroid. The drug is used for symptomatic treatment of moderate to severe corticosteroid-responsive dermatoses characterized by inflammation and/or pruritus, such as seborrheic dermatitis, atopic dermatitis, and psoriasis. The high potency of fluocinonide is advantageous for treating affected areas with thicker skin such as the palms and soles. Unlike non-fluorinated corticosteroids such as hydrocortisone, fluocinonide application should be avoided, if possible, on areas of thinner skin, such as the face and intertriginous areas, because of potential toxicities inherent in fluorinated compounds.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Topical Administration
-Wash hands before and after application. Use gloves if required by universal precautions. Apply sparingly in a thin film and rub gently into the cleansed, affected area. Use occlusive dressings only if specified by the physician.
-Hairy areas: Use gel or solution. Part hair and apply small amount to the affected area and rub in gently. Until the medication has dried, protect from washing, clothing, or rubbing. Hair may be washed as usual but not immediately after applying the medication.
The following adverse reactions (listed in decreasing order of occurrence) are reported such as fluocinonide and may occur more often when used with an occlusive dressing: skin irritation (including burning or edema), pruritus, xerosis (dry skin), folliculitis, hypertrichosis, acneiform rash/eruptions, skin hypopigmentation, perioral dermatitis, allergic maceration of the skin, secondary infection, skin atrophy, striae, telangiectasia, and miliaria. Maculopapular rash, purpura, vesicular rash, and erythema may also occur. Although skin atrophy usually occurs after prolonged use of topical corticosteroids, this effect may occur even with short-term use on intertriginous or flexor areas, or on the face. If irritation develops, discontinue topical corticosteroids and institute appropriate therapy. The anti-inflammatory activity of topical corticosteroids may also mask manifestations of infection. In the presence of dermatological infections, institute the use of an appropriate antifungal or antibacterial agent. If a favorable response does not promptly occur, discontinue the corticosteroid until the infection has been adequately controlled.
Signs and symptoms of corticosteroid withdrawal may occur with fluocinonide dose reduction or discontinuation, and supplemental systemic corticosteroids may be needed. For example, disease flare may occur and HPA axis suppression may be present.
Systemic absorption of topical corticosteroids such as fluocinonide can produce reversible hypothalamic-pituitary-adrenal (HPA) suppression with possible adrenocortical insufficiency and withdrawal symptoms after stopping treatment. In some patients, systemic absorption can produce manifestations of Cushing's syndrome, hypertension, hyperglycemia, and glycosuria. Percutaneous absorption of fluocinonide is dependent on many factors including the vehicle, the integrity of the epidermal barrier, duration of use, and use of an occlusive dressing. Children may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. Manifestations of adrenocortical insufficiency in children include linear growth inhibition and delayed weight gain. Increased intracranial pressure has also been reported in children receiving topical corticosteroids; manifestations of increased intracranial pressure include bulging fontanelles, headache, and bilateral papilledema (i.e., pseudotumor cerebri). Patients applying fluocinonide to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression (using the ACTH stimulation test, A.M. plasma cortisol test, and urinary free cortisol test). To minimize risk of HPA axis suppression, discontinue therapy when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.If HPA axis suppression is noted, an attempt should be made to withdraw the drug, reduce the frequency of application, or substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid.
Case reports describe visual impairment patients using topical corticosteroids, like fluocinonide, for eczema of the face. The visual impairment was secondary to the onset of ocular hypertension. Such adverse effects, if they occur, could lead to blindness. Cataracts have also been reported, usually with large doses or therapy > 6 months. Any patient who develops changes in vision during topical corticosteroid therapy should be evaluated for ocular hypertension. Low potency corticosteroids (e.g., hydrocortisone, dexamethasone) have been reported to be safer for short-term use around the eye area.
In general, excessive use of corticosteroids can lead to impaired wound healing. Fluocinonide should not be applied directly or near healing wounds. A skin ulcer may develop in patients with markedly impaired circulation who use topical corticosteroids.
Tolerance may occur with the prolonged use of topical corticosteroids. Tolerance is usually described as a decreased acute vasoconstrictive response to the agent after a period of days to weeks. This may explain the dramatic responses noted initially by patients early in topical corticosteroid treatment and an apparent diminished response with time. Tolerance is reversible and may be attenuated by interrupted or cyclic schedules of application (e.g., fluocinonide is given for 2-3 weeks, followed by a 1-week intermission).
Allergic contact dermatitis with corticosteroids such as fluocinonide is usually diagnosed by observing a failure to heal. Appropriate diagnostic patch testing may help with the diagnosis.
Fluocinonide is contraindicated in any patient with a history of severe hypersensitivity to other corticosteroids or any ingredients in the preparation. Although true corticosteroid hypersensitivity is rare, patients who have demonstrated a prior hypersensitivity reaction to fluocinonide should not receive any form of fluocinonide. It is possible, though also rare, that such patients will display cross-hypersensitivity to other corticosteroids. It is advisable that patients who have a hypersensitivity reaction to any corticosteroid undergo skin testing, which, although not a conclusive predictor, may help to determine if hypersensitivity to another corticosteroid exists. Such patients should be carefully monitored during and following the administration of any corticosteroid.
Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which increase systemic absorption include application of high-potency corticosteroids (such as fluocinonide), use over large surface areas, prolonged use, use in areas where the epidermal barrier is disrupted (i.e., skin abrasion), and the use of an occlusive dressing. Patients receiving large doses of a potent topical corticosteroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression using ACTH stimulation, AM plasma cortisol and urinary free-cortisol 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 corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of the topical corticosteroid. Infrequently, signs and symptoms of corticosteroid withdrawal may occur, requiring supplemental systemic corticosteroids.
Topical corticosteroids, like fluocinonide, should be used with caution in patients with diabetes mellitus. Exacerbation of diabetes may occur with systemic absorption of the topical corticosteroid. Use of topical corticosteroids may further delay healing of skin ulcers in diabetic patients.
Use most topical formulations of fluocinonide with caution in children and infants less than 2 years of age; most topical fluocinonide products are not labeled for use in these populations. Safety and efficacy of Vanos brand topical cream in neonates, infants, and children younger than 12 years of age have not been established, and use is not recommended. Pediatric patients may absorb proportionally larger amounts of topical corticosteroids due to a larger skin surface area to body weight ratio, and therefore are more susceptible to developing systemic toxicity, especially with very-high-potency products. Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, growth inhibition (linear growth retardation and delayed weight gain), and increased intracranial pressure have been reported in children receiving topical corticosteroids. Administration of fluocinonide should be limited to the least amount compatible with an effective therapeutic regimen. If children are being treated in the diaper area, tight-fitting diapers or plastic pants should be avoided as these garments may act as an occlusive dressing and increase systemic absorption of the drug.
There are no adequate and well-controlled studies of topical application of fluocinonide during pregnancy. Topical corticosteroids, including fluocinonide, should not be used in large amounts, on large areas, or for prolonged periods of time in pregnant women. Guidelines recommend mild to moderate potency agents over potent corticosteroids, which should be used in short durations. Fetal growth restriction and a significantly increased risk of low birthweight has been reported with use of potent or very potent topical corticosteroids during the third trimester, particularly when using more than 300 grams. 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.
It is not known whether topical administration of fluocinonide could result in sufficient systemic absorption to produce detectable quantities in breast milk. However, most dermatologists stress that topical corticosteroids can be safely used during lactation and breast-feeding. If applied topically, care should be used to ensure the infant will not come into direct contact with the area of application, such as the breast. Increased blood pressure has been reported in an infant whose mother applied a high potency topical corticosteroid ointment directly to the nipples. Consider therapy with less-potent topical agents, like hydrocortisone or triamcinolone, in nursing mothers requiring long-term therapy with a topical corticosteroid. Consider the benefits of breast-feeding, the risk of potential infant drug exposure, and the risk of an untreated or inadequately treated condition. If a breast-feeding infant experiences an adverse effect related to a maternally ingested drug, healthcare providers are encouraged to report the adverse effect to the FDA.
The normal inflammatory response to local infections can be masked by fluocinonide. Application of topical corticosteroids to areas of infection, including tuberculosis of the skin, dermatologic fungal infection, and cutaneous or systemic viral infection (e.g., measles or varicella), should be initiated or continued only if the appropriate antiinfective treatment is instituted. Herpes infection may be transmitted to other sites, including the eye. If the infection does not respond to the antimicrobial therapy, the concurrent use of the topical corticosteroid should be discontinued until the infection is controlled. Topical corticosteroids may delay the healing of non-infected wounds, such as venous stasis ulcers. Use fluocinonide preparations with caution in patients with markedly impaired circulation or peripheral vascular disease due to the potential for skin ulceration.
As with other potent fluorinated topical corticosteroids, fluocinonide should not be used to treat acne vulgaris, acne rosacea, or perioral dermatitis. Fluocinonide may aggravate these conditions. In general, fluocinonide preparations should not be applied to the face, groin, or axillae. Care should be taken to avoid use around the eyes; ophthalmic administration should be avoided. Visual impairment, ocular hypertension and worsened cataracts have been reported with ocular exposure to other high potency topical corticosteroids. Preexisting glaucoma may be aggravated if fluocinonide is used in the periorbital area.
Topical corticosteroids, like fluocinonide, should be used for brief periods or under close medical supervision in patients with evidence of pre-existing skin atrophy, especially geriatric patients. Purpura and skin lacerations that may raise the skin and subcutaneous tissue from deep fascia may be more likely to occur with the use of topical corticosteroids in geriatric patients. Use of lower potency topical corticosteroids may be necessary in some patients.
For the treatment of corticosteroid-responsive dermatoses, including atopic dermatitis, localized vitiligo, eczema, phimosis, lichen planus, and localized bullous pemphigoid:
-for the treatment of corticosteroid-responsive dermatoses other than atopic dermatitis:
Topical dosage (0.05% cream, gel, ointment, or solution):
Adults: Apply a thin layer topically to the affected skin area(s) 2 to 4 times daily.
Children and Adolescents: Apply a thin layer topically to the affected skin area(s) 2 to 4 times daily.
Topical dosage (0.1% cream):
Adults: Apply a thin layer topically to the affected skin area(s) once or twice daily (Max: 60 g/week) for up to 2 weeks. If no response is seen within 2 weeks, reassess treatment options.
Children and Adolescents 12 to 17 years: Apply a thin layer topically to the affected skin area(s) once or twice daily (Max: 60 g/week) for up to 2 weeks. If no response is seen within 2 weeks, reassess treatment options.
-for the treatment of atopic dermatitis:
Topical dosage (0.05% cream, gel, ointment, or solution):
Adults: Apply a thin layer topically to the affected skin area(s) 2 to 4 times daily.
Children and Adolescents: Apply a thin layer topically to the affected skin area(s) 2 to 4 times daily.
Topical dosage (0.1% cream):
Adults: Apply a thin layer topically to the affected skin area(s) once daily (Max: 60 g/week) for up to 2 weeks. If no response is seen within 2 weeks, reassess treatment options.
Children and Adolescents 12 to 17 years: Apply a thin layer topically to the affected skin area(s) once daily (Max: 60 g/week) for up to 2 weeks. If no response is seen within 2 weeks, reassess treatment options.
For the treatment of psoriasis:
Topical dosage (0.05% cream, ointment, gel, solution):
Adults: Apply a thin layer topically to the affected skin area(s) 2 to 4 times daily. The duration of the therapy depends on factors such as the topical corticosteroid potency, disease severity and anatomic location, and age. After improvement, may consider transitioning to lower-potency corticosteroid, using intermittent therapy, and combining treatment with noncorticosteroidal agents. Taper by reducing use to every other day, then twice weekly, then discontinue if adequate control is maintained. Guidelines recommend class 1 to 5 topical corticosteroids for up to 4 weeks for plaque psoriasis not involving intertriginous areas and class 1 to 7 topical corticosteroids for a minimum of up to 4 weeks for scalp psoriasis. Use of topical corticosteroids for more than 12 weeks may be considered under careful supervision.
Children and Adolescents: Apply a thin layer topically to the affected skin area(s) 2 to 4 times daily. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.
Topical dosage (0.1% cream):
Adults: Apply a thin layer topically to the affected skin area(s) once or twice daily. Max: 60 g/week. Twice daily application has been shown to be more effective in achieving treatment success during 2 weeks of treatment. Treatment beyond 2 consecutive weeks is not recommended because safety has not been established. The duration of the therapy depends on factors such as the topical corticosteroid potency, disease severity and anatomic location, and age. After improvement, may consider transitioning to lower-potency corticosteroid, using intermittent therapy, and combining treatment with noncorticosteroidal agents. Taper by reducing use to every other day, then twice weekly, then discontinue if adequate control is maintained. Guidelines recommend class 1 to 5 topical corticosteroids for up to 4 weeks for plaque psoriasis not involving intertriginous areas and class 1 to 7 topical corticosteroids for a minimum of up to 4 weeks for scalp psoriasis. Use of topical corticosteroids for more than 12 weeks may be considered under careful supervision.
Children and Adolescents 12 to 17 years: Apply a thin layer topically to the affected skin area(s) once or twice daily. Max: 60 g/week. Twice daily application has been shown to be more effective in achieving treatment success during 2 weeks of treatment. Treatment beyond 2 consecutive weeks is not recommended because safety has not been established. Guidelines recommend topical corticosteroids as monotherapy for short-term treatment of localized psoriasis.
Maximum Dosage Limits:
While in general corticosteroid dosage must be individualized and is highly variable depending on the nature and severity of the disease and on patient age and response, the area of skin where fluocinonide is applied should be limited.
-Adults
4 applications/day topically; Vanos 2 applications/day topically or 60 g/week for <=2 weeks.
-Elderly
4 applications/day topically; Vanos 2 applications/day topically or 60 g/week for <=2 weeks.
-Adolescents
4 applications/day topically; Vanos 2 applications/day topically or 60 g/week for <=2 weeks.
-Children
>= 12 years: 4 applications/day topically; Vanos 2 applications/day topically or 60 g/week for <=2 weeks.
>= 2 years and < 12 years: 4 applications/day topically; safety and efficacy of Vanos have not been established.
< 2 years: Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
Metyrapone: (Major) Medications which affect pituitary or adrenocortical function, including all corticosteroid therapy, should be discontinued prior to and during testing with metyrapone. Patients taking inadvertent doses of corticosteroids on the test day may exhibit abnormally high basal plasma cortisol levels and a decreased response to the test. Although systemic absorption of topical corticosteroids is minimal, temporary discontinuation of these products should be considered if possible to reduce the potential for interference with the test results.
Voriconazole: (Moderate) Monitor for potential adrenal dysfunction with concomitant use of voriconazole and fluocinonide. In patients taking corticosteroids, voriconazole-associated CYP3A4 inhibition of their metabolism may lead to corticosteroid excess and adrenal suppression. Corticosteroid exposure is likely to be increased. Voriconazole is a strong CYP3A4 inhibitor, and fluocinonide is a CYP3A4 substrate.
Topical corticosteroids exhibit anti-inflammatory, antipruritic, and vasoconstrictive properties. At the cellular level, corticosteroids induce peptides called lipocortins. Lipocortins antagonize phospholipase A2, an enzyme which causes the breakdown of leukocyte lysosomal membranes to release arachidonic acid. This action decreases the subsequent formation and release of endogenous inflammatory mediators including prostaglandins, kinins, histamine, liposomal enzymes and the complement system. Early anti-inflammatory effects of topical corticosteroids include the inhibition of macrophage and leukocyte movement and activity in the inflamed area by reversing vascular dilation and permeability. Later inflammatory processes such as capillary production, collagen deposition, keloid (scar) formation also are inhibited by corticosteroids. Clinically, these actions correspond to decreased edema, erythema, pruritus, plaque formation and scaling of the affected skin.
Pharmacokinetics:
Fluocinonide is administered topically. It is unknown whether topically applied corticosteroids cross the placenta or are distributed into breast milk. Systemically absorbed fluocinonide is rapidly cleared as inactive metabolites via hepatic pathways. The unchanged parent compound and metabolites are excreted renally.
-Route-Specific Pharmacokinetics
Topical Route
The amount of fluocinonide absorbed following topical application is variable and dependent on the condition of the affected skin. Absorption is enhanced through application on abraded or inflamed skin, or when used on areas where the stratum corneum is thin such as the eyelids, genitalia, and face. In addition, application under occlusion, which increases skin hydration and temperature, enhances penetration through the stratum corneum. Although penetration through the epidermis is usually minimal, prolonged use of fluorinated adrenocorticoids, administration to large body surface areas, or application under occlusion can result in undesirable effects such as adrenal suppression (see Adverse Reactions).