Label: FLUOCINONIDE- fluocinonide solution

  • NDC Code(s): 0168-0134-60
  • Packager: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated July 16, 2013

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  • SPL UNCLASSIFIED SECTION

    FOR TOPICAL USE ONLY.

    Rx only

    NOT FOR OPHTHALMIC USE.

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  • DESCRIPTION:

    Fluocinonide Topical Solution USP, 0.05% is intended for topical administration. The active component is the corticosteroid Fluocinonide, which is the 21-acetate ester of fluocinolone acetonide. The chemical name of Fluocinonide is 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 a molecular formula of C26H32F2O7 and a molecular weight of 494.54.

    It has the following structural formula:

    chemical structure

    Each mL of Fluocinonide Topical Solution USP, 0.05% contains: fluocinonide 0.5 mg in a solution of alcohol (35%), diisopropyl adipate, citric acid and propylene glycol. In this formulation, the active ingredient is totally in solution.

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  • 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.

    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. A significantly greater amount of fluocinonide is absorbed from the solution than from cream or gel formulations. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase the 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.

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  • INDICATIONS AND USAGE:

    Fluocinonide Topical Solution USP, 0.05% is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

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  • CONTRAINDICATIONS:

    Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

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  • PRECAUTIONS:

    General: 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, the addition of occlusive dressings and dosage form. 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.

    Pediatric patients may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (See PRECAUTIONS - Pediatric Use).

    This preparation is not for ophthalmic use. Severe irritation is possible if fluocinonide topical solution contacts the eye. If that should occur, immediate flushing of the eye with a large volume of water is recommended.

    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.

    Information for Patients: Patients using topical corticosteroids should receive the following information and instructions:

    1.
    This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes. If there is contact with the eye(s) and severe irritation occurs, immediately flush with large volume of water.
    2.
    Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
    3.
    The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
    4.
    Patients should report any signs of local adverse reactions especially under occlusive dressings.
    5.
    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.

    Laboratory Tests: The following tests may be helpful in evaluating the HPA axis suppression:

    Urinary free cortisol test; ACTH stimulation test.

    Carcinogenesis, Mutagenesis, and Impairment of Fertility: 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.

    Pregnancy Category C: 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.

    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.

    Pediatric Use: 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 children receiving topical corticosteroids. Manifestations of adrenal suppression in children 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 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.

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  • 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, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

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  • OVERDOSAGE:

    Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

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  • DOSAGE AND ADMINISTRATION:

    Fluocinonide Topical Solution 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.

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  • HOW SUPPLIED:

    Fluocinonide Topical Solution USP, 0.05% is supplied in:

          60 mL bottles          NDC 0168-0134-60.

    Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].
    Avoid excessive heat above 40°C (104°F).

    E. FOUGERA & CO.
    A division of
    Fougera
    PHARMACEUTICALS INC.
    Melville, New York 11747

    I2134D
    R07/13
    #49

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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL CONTAINER

    NDC 0168-0134-60

    FOUGERA®

    FLUOCINONIDE
    TOPICAL SOLUTION
    USP, 0.05%

    60 mL

    FOR TOPICAL USE ONLY.
    NOT FOR OPHTHALMIC USE.

    Rx only

    E. FOUGERA & CO.
    A division of Fougera Pharmaceuticals Inc.
    Melville, New York 11747

    Fluocinonide Topl Soln USP, 0.05% Label
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  • PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 60mL CARTON

    NDC 0168-0134-60

    FOUGERA®

    FLUOCINONIDE
    TOPICAL
    SOLUTION
    USP, 0.05%

    60 mL

    FOR TOPICAL USE ONLY.
    NOT FOR OPHTHALMIC USE.

    Rx only

    E. FOUGERA & CO.
    A division of
    Fougera Pharmaceuticals Inc.
    Melville, New York 11747

    Fluocinonide Topl Soln USP, 0.05% Carton 60mL
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  • INGREDIENTS AND APPEARANCE
    FLUOCINONIDE 
    fluocinonide solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0134
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    fluocinonide (UNII: 2W4A77YPAN) (fluocinonide - UNII:2W4A77YPAN) fluocinonide 0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    alcohol (UNII: 3K9958V90M)  
    diisopropyl adipate (UNII: P7E6YFV72X)  
    citric acid monohydrate (UNII: 2968PHW8QP)  
    propylene glycol (UNII: 6DC9Q167V3)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0168-0134-60 1 in 1 CARTON 02/27/1995
    1 60 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA072934 02/27/1995
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)
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