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  • CLASSES

    Plain Topical Corticosteroids

    DEA CLASS

    Rx

    DESCRIPTION

    Topical high-potency synthetic fluorinated corticosteroid
    Used for moderate to severe corticosteroid-responsive dermatoses, including psoriasis

    COMMON BRAND NAMES

    Lidex, Lidex -E, Vanos

    HOW SUPPLIED

    Fluocinonide/Lidex Topical Gel: 0.05%
    Fluocinonide/Lidex Topical Ointment: 0.05%
    Fluocinonide/Lidex Topical Sol: 0.05%
    Fluocinonide/Lidex/Lidex -E/Vanos Topical Cream: 0.05%, 0.1%

    DOSAGE & INDICATIONS

    For the treatment of pruritus and topical inflammation associated with corticosteroid-responsive dermatoses such as alopecia areata, atopic dermatitis, cutaneous T-cell lymphoma (CTCL) (aka mycosis fungoides), contact dermatitis, severe Rhus dermatitis (due to plants like poison ivy), discoid lupus erythematosus, generalized exfoliative dermatitis, granuloma annulare, keloids, lichen planus, lichen simplex, lichen striatus, severe eczema (including severe hyperkeratotic eczema, severe nummular eczema, and severe eczematous conditions of the hands or feet), keloids, necrobiosis lipoidica diabeticorum, pemphigoid, pompholyx (dyshidrosis), nodular prurigo, pemphigus, pityriasis rosea, severe pruritus, psoriasis, sarcoidosis, seborrheic dermatitis, sunburn, or urticaria.
    NOTE: Systemic therapy or intralesional injection of corticosteroids may be necessary for some conditions based on the type and severity of the disorder or inadequate response to topical therapy.
    For the treatment of plaque-type psoriasis affecting up to 10% of the body surface area (BSA).
    Topical dosage (VANOS 0.1%)
    Adults, Adolescents, and Children >= 12 years

    Apply a thin layer to the affected area of the skin once or twice daily. Only small areas should be treated at a time. Treatment should be limited to 2 consecutive weeks and the total dosage should not exceed 60 g/week. Discontinue therapy once psoriasis is controlled.

    Topical dosage
    Adults, Adolescents, and Children >= 2 years

    Apply sparingly, 1 to 4 times per day to affected areas. Multiple lesions should be treated sequentially, applying the medication to only a small area of the skin at a time. Resistant dermatoses may require occlusion of the affected areas.

    MAXIMUM DOSAGE

    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.

    DOSING CONSIDERATIONS

    Hepatic Impairment

    Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.

    Renal Impairment

    Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.

    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.

    STORAGE

    Lidex:
    - Avoid excessive heat (above 104 degrees F)
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Lidex -E:
    - Do not refrigerate
    - Store at controlled room temperature (between 68 and 77 degrees F)
    Vanos:
    - Store between 68 to 77 degrees F, excursions permitted 59 to 86 degrees F

    CONTRAINDICATIONS / PRECAUTIONS

    Corticosteroid hypersensitivity

    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.

    Cushing's syndrome, hypothalamic-pituitary-adrenal (HPA) suppression, occlusive dressing, skin abrasion

    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.

    Diabetes mellitus

    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.

    Children, growth inhibition, increased intracranial pressure, infants, neonates

    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.

    Pregnancy

    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.

    Breast-feeding

    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.

    Fungal infection, herpes infection, infection, measles, peripheral vascular disease, tuberculosis, varicella, viral infection

    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.

    Acne rosacea, acne vulgaris, cataracts, glaucoma, ocular exposure, ophthalmic administration, perioral dermatitis

    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.

    Geriatric, skin atrophy

    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.

    ADVERSE REACTIONS

    Severe

    skin atrophy / Delayed / Incidence not known
    increased intracranial pressure / Early / Incidence not known
    papilledema / Delayed / Incidence not known
    visual impairment / Early / Incidence not known
    ocular hypertension / Delayed / Incidence not known

    Moderate

    erythema / Early / 1.0-10.0
    withdrawal / Early / Incidence not known
    glycosuria / Early / Incidence not known
    Cushing's syndrome / Delayed / Incidence not known
    hyperglycemia / Delayed / Incidence not known
    growth inhibition / Delayed / Incidence not known
    adrenocortical insufficiency / Delayed / Incidence not known
    pseudotumor cerebri / Delayed / Incidence not known
    hypertension / Early / Incidence not known
    hypothalamic-pituitary-adrenal (HPA) suppression / Delayed / Incidence not known
    cataracts / Delayed / Incidence not known
    skin ulcer / Delayed / Incidence not known
    impaired wound healing / Delayed / Incidence not known
    tolerance / Delayed / Incidence not known
    contact dermatitis / Delayed / Incidence not known

    Mild

    maculopapular rash / Early / 1.0-10.0
    xerosis / Delayed / 1.0-10.0
    pruritus / Rapid / 1.0-10.0
    skin irritation / Early / 1.0-10.0
    hypertrichosis / Delayed / Incidence not known
    purpura / Delayed / Incidence not known
    telangiectasia / Delayed / Incidence not known
    acneiform rash / Delayed / Incidence not known
    miliaria / Delayed / Incidence not known
    folliculitis / Delayed / Incidence not known
    striae / Delayed / Incidence not known
    infection / Delayed / Incidence not known
    skin hypopigmentation / Delayed / Incidence not known
    headache / Early / Incidence not known

    DRUG INTERACTIONS

    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.

    PREGNANCY AND LACTATION

    Pregnancy

    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.

    MECHANISM OF ACTION

    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.

    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).