Label: BETAMETHASONE DIPROPIONATE- betamethasone dipropionate lotion, augmented

  • NDC Code(s): 0168-0267-30, 0168-0267-60
  • 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 May 21, 2018

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use BETAMETHASONE DIPROPIONATE LOTION (augmented) safely and effectively. See full prescribing information for BETAMETHASONE DIPROPIONATE LOTION (augmented).

    BETAMETHASONE DIPROPIONATE lotion, for topical use
    Initial U.S. Approval: 1983

    RECENT MAJOR CHANGES

     
    Warnings and Precautions, Visual Disturbance ( 5.2) 03/2018

    INDICATIONS AND USAGE

    Betamethasone dipropionate lotion (augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. (1)

    DOSAGE AND ADMINISTRATION

    Apply a few drops to the affected skin areas once or twice daily and massage lightly until the lotion disappears.( 2)
    Discontinue therapy when control is achieved. ( 2)
    Limit therapy to no more than 2 consecutive weeks. ( 2)
    Use no more than 50 mL per week. ( 2)
    Do not use with occlusive dressings unless directed by a physician. ( 2)
    Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. ( 2)
    Not for oral, ophthalmic, or intravaginal use. ( 2)

    DOSAGE FORMS AND STRENGTHS

    Lotion, 0.05% ( 3)

    CONTRAINDICATIONS

    Hypersensitivity to any component of this medicine. ( 4)

    WARNINGS AND PRECAUTIONS

    Effects on endocrine system: Betamethasone dipropionate lotion (augmented), 0.05% can cause reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency during and after withdrawal of treatment. Risk factor(s) include the use of high-potency topical corticosteroids, use over a large surface area or to areas under occlusion, prolonged use, altered skin barrier, liver failure, and use in pediatric patients. Modify use should HPA axis suppression develop. ( 5.1, 8.4)
    Visual disturbances: Betamethasone dipropionate lotion (augmented), 0.05% may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ( 5.2)

    ADVERSE REACTIONS

    Most common adverse reactions (<1%) are: erythema, folliculitis, pruritus, and vesiculation. ( 6.1)

    To report SUSPECTED ADVERSE REACTIONS, contact Fougera Pharmaceuticals Inc. at 1-800-645-9833 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

    See 17 for PATIENT COUNSELING INFORMATION.

    Revised: 5/2018

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  • FULL PRESCRIBING INFORMATION: CONTENTS*
  • 1 INDICATIONS AND USAGE

    Betamethasone dipropionate lotion (augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older.

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  • 2 DOSAGE AND ADMINISTRATION

    Apply a few drops of betamethasone dipropionate lotion (augmented), 0.05% to the affected skin areas once or twice daily and massage lightly until the lotion disappears.

    Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Betamethasone dipropionate lotion (augmented), 0.05% is a super-high-potency topical corticosteroid. Treatment with betamethasone dipropionate lotion (augmented), 0.05% should be limited to 2 consecutive weeks and amounts should not exceed 50 mL per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis [see Warnings and Precautions (5.1)].

    Betamethasone dipropionate lotion (augmented), 0.05% should not be used with occlusive dressings unless directed by a physician.

    Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site.

    Avoid contact with eyes. Wash hands after each application.

    Betamethasone dipropionate lotion (augmented), 0.05% is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

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  • 3 DOSAGE FORMS AND STRENGTHS

    Lotion, 0.05%. Each gram of betamethasone dipropionate lotion USP (augmented), 0.05% contains 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a colorless, clear to translucent lotion.

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  • 4 CONTRAINDICATIONS

    Betamethasone dipropionate lotion (augmented), 0.05% is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation.

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  • 5 WARNINGS AND PRECAUTIONS

    5.1 Effects on Endocrine System

    Betamethasone dipropionate lotion (augmented), 0.05% can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency. This may occur during treatment or after withdrawal of treatment. Factors that predispose to HPA axis suppression include the use of high-potency steroids, large treatment surface areas, prolonged use, use of occlusive dressings, altered skin barrier, liver failure, and young age. Evaluation for HPA axis suppression may be done by using the adrenocorticotropic hormone (ACTH) stimulation test.

    In a trial evaluating the effects of betamethasone dipropionate lotion (augmented), 0.05% on the HPA axis, betamethasone dipropionate lotion (augmented), 0.05% was applied once daily at 7 mL per day for 21 days to diseased scalp and body skin in subjects with scalp psoriasis, betamethasone dipropionate lotion (augmented), 0.05% was shown to lower plasma cortisol levels below normal limits in 2 out of 11 subjects. HPA axis suppression in these subjects was transient and returned to normal within a week. In one of these subjects, plasma cortisol levels returned to normal while treatment continued.

    If HPA axis suppression is documented, gradually withdraw the drug, reduce the frequency of application, or substitute with a less potent corticosteroid. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

    Cushing's syndrome and hyperglycemia may also occur with topical corticosteroids. These events are rare and generally occur after prolonged exposure to excessively large doses, especially of high-potency topical corticosteroids.

    Pediatric patients may be more susceptible to systemic toxicity due to their larger skin surface to body mass ratios [see Use in Specific Populations (8.4)].

    5.2 Visual Disturbance

    Use of topical corticosteroids, including betamethasone dipropionate lotion (augmented), 0.05%, may increase the risk of posterior subcapsular cataracts and glaucoma. Cataracts and glaucoma have been reported postmarketing with the use of topical corticosteroid products, including betamethasone dipropionate lotion (augmented), 0.05% [see Adverse Reactions (6.2)].

    Avoid contact of betamethasone dipropionate lotion (augmented), 0.05% with eyes. Advise patients to report any visual symptoms and consider referral to an ophthalmologist for evaluation.

    5.3 Allergic Contact Dermatitis

    Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation. Such an observation should be corroborated with appropriate diagnostic patch testing. If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

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  • 6 ADVERSE REACTIONS

    6.1 Clinical Trials Experience

    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

    In controlled clinical trials, adverse reactions associated with the use of betamethasone dipropionate lotion (augmented), 0.05% reported at a frequency of less than 1% included erythema, folliculitis, pruritus, and vesiculation.

    6.2 Postmarketing Experience

    Because adverse reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

    Postmarketing reports for local adverse reactions to topical corticosteroids may also include: skin atrophy, striae, telangiectasias, burning, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, and miliaria.

    Hypersensitivity reactions, consisting of predominantly skin signs and symptoms, e.g., contact dermatitis, pruritus, bullous dermatitis, and erythematous rash have been reported.

    Ophthalmic adverse reactions of cataracts, glaucoma, increased intraocular pressure, and central serous chorioretinopathy have been reported with the use of topical corticosteroids, including topical betamethasone products.

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  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Teratogenic Effects: Pregnancy Category C

    There are no adequate and well-controlled studies in pregnant women. Betamethasone dipropionate lotion (augmented), 0.05% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

    Betamethasone dipropionate has been shown to be teratogenic in rabbits when given by the intramuscular route at doses of 0.05 mg/kg. The abnormalities observed included umbilical hernias, cephalocele, and cleft palate.

    8.3 Nursing Mothers

    Systemically administered corticosteroids appear in human milk and can suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids can result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when betamethasone dipropionate lotion (augmented), 0.05% is administered to a nursing woman.

    8.4 Pediatric Use

    Use of betamethasone dipropionate lotion (augmented), 0.05% in pediatric patients younger than 13 years of age is not recommended due to the potential for HPA axis suppression [see Warnings and Precautions (5.1)].

    In an open-label HPA axis safety trial in subjects 3 months to 12 years of age with atopic dermatitis, betamethasone dipropionate cream (augmented), 0.05% was applied twice daily for 2 to 3 weeks over a mean body surface area of 58% (range 35% to 95%). In 19 of 60 (32%) evaluable subjects, adrenal suppression was indicated by either a ≤5 mcg/dL pre-stimulation cortisol, or a cosyntropin post-stimulation cortisol ≤18 mcg/dL and/or an increase of <7 mcg/dL from the baseline cortisol. Out of the 19 subjects with HPA axis suppression, 4 subjects were tested 2 weeks after discontinuation of betamethasone dipropionate cream (augmented), 0.05% and 3 of the 4 (75%) had complete recovery of HPA axis function. The proportion of subjects with adrenal suppression in this trial was progressively greater, the younger the age group.

    Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical drugs. They are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency upon the use of topical corticosteroids.

    Rare systemic effects such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids.

    Local adverse reactions including skin atrophy have also been reported with use of topical corticosteroids in pediatric patients.

    Avoid use of betamethasone dipropionate lotion (augmented), 0.05% in the treatment of diaper dermatitis.

    8.5 Geriatric Use

    Clinical trials of betamethasone dipropionate lotion (augmented), 0.05% included 56 subjects who were 65 years of age and over and 9 subjects who were 75 years of age and over. There was a numerical difference for application site reactions (most frequently reported events were burning and stinging) which occurred in 15% (10/65) of geriatric subjects and 11% (38/342) of subjects less than 65 years of age. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. However, greater sensitivity of some older individuals cannot be ruled out.

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  • 11 DESCRIPTION

    Betamethasone Dipropionate Lotion USP (Augmented), 0.05% contains betamethasone dipropionate USP, a synthetic adrenocorticosteroid, for topical use. Betamethasone, an analog of prednisolone, has a high degree of corticosteroid activity and a slight degree of mineralocorticoid activity. Betamethasone dipropionate is the 17,21-dipropionate ester of betamethasone.

    Chemically, betamethasone dipropionate is 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione 17,21-dipropionate, with the molecular formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:

    Chemical Structure

    It is a white to creamy-white, odorless powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol.

    Each gram of Betamethasone Dipropionate Lotion USP (Augmented), 0.05% contains: 0.643 mg betamethasone dipropionate, USP (equivalent to 0.5 mg betamethasone) in a colorless, clear to translucent lotion base of purified water, isopropyl alcohol (30%), phosphoric acid used to adjust the pH, hydroxypropyl cellulose, propylene glycol, and monobasic sodium phosphate (monohydrate).

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  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Corticosteroids play a role in cellular signaling, immune function, inflammation, and protein regulation; however, the precise mechanism of action of betamethasone dipropionate lotion (augmented), 0.05% in corticosteroid responsive dermatoses is unknown.

    12.2 Pharmacodynamics

    Vasoconstrictor Assay

    Trials performed with betamethasone dipropionate lotion (augmented), 0.05% indicate that it is in the super-high range of potency as demonstrated in vasoconstrictor trials in healthy subjects when compared with other topical corticosteroids. However, similar blanching scores do not necessarily imply therapeutic equivalence.

    12.3 Pharmacokinetics

    No pharmacokinetic trials have been conducted with betamethasone dipropionate lotion (augmented), 0.05%.

    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 [see Dosage and Administration (2)].

    Topical corticosteroids can be absorbed through normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids [see Dosage and Administration (2)].

    Once absorbed through the skin, topical corticosteroids enter pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees, are metabolized primarily in the liver, and excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

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  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Long-term animal studies have not been performed to evaluate the carcinogenic potential of betamethasone dipropionate. Betamethasone was negative in the bacterial mutagenicity assay (Salmonella typhimurium and Escherichia coli), and in the mammalian cell mutagenicity assay (CHO/HGPRT). It was positive in the in vitro human lymphocyte chromosome aberration assay, and equivocal in the in vivo mouse bone marrow micronucleus assay.

    Studies in rabbits, mice, and rats using intramuscular doses up to 1, 33, and 2 mg/kg, respectively, resulted in dose-related increases in fetal resorptions in rabbits and mice.

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  • 14 CLINICAL STUDIES

    The safety and efficacy of betamethasone dipropionate lotion (augmented), 0.05% for the treatment of corticosteroid- responsive dermatoses have been evaluated in two randomized vehicle controlled trials, one in scalp psoriasis and one in seborrheic dermatitis. A total of 263 subjects, of whom 131 received betamethasone dipropionate lotion (augmented), 0.05% were included in these trials. These trials evaluated betamethasone dipropionate lotion (augmented), 0.05% applied once daily for 21 days.

    Betamethasone dipropionate lotion (augmented), 0.05% was shown to be effective in relieving the signs and symptoms of corticosteroid responsive dermatoses.

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  • 16 HOW SUPPLIED/STORAGE AND HANDLING

    Betamethasone Dipropionate Lotion USP (Augmented), 0.05% is supplied as follows:
    NDC 0168-0267-30, 30 mL bottle
    NDC 0168-0267-60, 60 mL bottle

    Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

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  • 17 PATIENT COUNSELING INFORMATION

    Inform patients of the following:

    Discontinue therapy when control is achieved, unless directed otherwise by the physician.
    Use no more than 50 mL per week of betamethasone dipropionate lotion (augmented), 0.05% and for no longer than 2 consecutive weeks.
    Avoid contact with the eyes.
    Advise patients to report any visual symptoms to their healthcare providers.
    Avoid use of betamethasone dipropionate lotion (augmented), 0.05% on the face, underarms, or groin areas unless directed by the physician.
    Do not occlude the treatment area with bandage or other covering, unless directed by the physician.
    Note that local reactions and skin atrophy are more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids.
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  • SPL UNCLASSIFIED SECTION

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

    46230397A
    R05/18
    #105

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  • PRINCIPAL DISPLAY PANEL - 30 mL Label

    NDC 0168-0267-30

    Fougera®

     
    BETAMETHASONE
    DIPROPIONATE LOTION
    USP (AUGMENTED), 0.05%*
    *Strength expressed as betamethasone
     
    For topical use only.
    Not for oral, ophthalmic, or intravaginal use.
     
    Rx only

    30 mL

    PRINCIPAL DISPLAY PANEL 30mL LABEL
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  • PRINCIPAL DISPLAY PANEL - 30 mL Carton

    NDC 0168-0267-30

    Fougera®

     
    BETAMETHASONE
    DIPROPIONATE LOTION
    USP (AUGMENTED)
    0.05%*
    *Strength expressed as betamethasone
     
    Rx only
     
    For topical use only.
    Not for oral, ophthalmic,
    or intravaginal use.

    30 mL

    PRINCIPAL DISPLAY PANEL 30mL CTN
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  • INGREDIENTS AND APPEARANCE
    BETAMETHASONE DIPROPIONATE 
    betamethasone dipropionate lotion, augmented
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0267
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    BETAMETHASONE DIPROPIONATE (UNII: 826Y60901U) (BETAMETHASONE - UNII:9842X06Q6M) BETAMETHASONE 0.5 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    isopropyl alcohol (UNII: ND2M416302)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    HYDROXYPROPYL CELLULOSE (1200000 MW) (UNII: RFW2ET671P)  
    phosphoric acid (UNII: E4GA8884NN)  
    SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0168-0267-30 30 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/21/2007
    2 NDC:0168-0267-60 60 mL in 1 BOTTLE; Type 0: Not a Combination Product 05/21/2007
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077111 05/21/2007
    Labeler - E. Fougera & Co. a division of Fougera Pharmaceuticals Inc. (043838424)
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