Drug Facts
Composition & Profile
Identifiers & Packaging
16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-6787 NDC: 50090-6787-0 50 g in a TUBE / 1 in a CARTON; BETAMETHASONE DIPROPIONATE Label Image
- 16 HOW SUPPLIED/STORAGE AND HANDLING Product: 50090-6787 NDC: 50090-6787-0 50 g in a TUBE / 1 in a CARTON
- BETAMETHASONE DIPROPIONATE Label Image
Overview
Betamethasone dipropionate ointment 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 empirical formula C 28 H 37 FO 7 , a molecular weight of 504.6 and the following structural formula: It is a white to cream-white, odorless powder practically insoluble in water, freely soluble in acetone, in methylene chloride and in chloroform, sparingly soluble in ethanol (96%). Each gram of betamethasone dipropionate ointment USP (augmented), 0.05% contains 0.643 mg betamethasone dipropionate USP (equivalent to 0.5 mg betamethasone), in a white to off-white opaque ointment base of propylene glycol, propylene glycol monopalmitostearate, white petrolatum and white wax. structure
Indications & Usage
Betamethasone dipropionate ointment USP (augmented) 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. Betamethasone dipropionate ointment USP (augmented) 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 & Administration
Apply a thin film of betamethasone dipropionate ointment USP (augmented) to the affected skin areas once or twice daily. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Betamethasone dipropionate ointment USP (augmented) is a super-high-potency topical corticosteroid. Treatment with betamethasone dipropionate ointment USP (augmented) should not exceed 50 g 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 ointment USP (augmented) 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 ointment USP (augmented) is for topical use only. It is not for oral, ophthalmic, or intravaginal use. • Apply a thin film to the affected skin areas once or twice daily. ( 2 ) • Discontinue therapy when control is achieved. ( 2 ) • Limit therapy to no more than 2 consecutive weeks. ( 2 ) • Use no more than 50 g 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 )
Warnings & Precautions
Effects on endocrine system: Betamethasone dipropionate ointment (augmented) 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 ) Opthalmic Adverse Reactions: Betamethasone dipropionate ointment (augmented) may increase the risk of cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. ( 5.2 ) 5.1 Effects on Endocrine System Betamethasone dipropionate ointment (augmented) 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 ointment (augmented) on the HPA axis, at 14 g per day, betamethasone dipropionate ointment (augmented) was shown to suppress the plasma levels of adrenal cortical hormones following repeated application to diseased skin in subjects with psoriasis. These effects were reversible upon discontinuation of treatment. At 7 g per day, betamethasone dipropionate ointment (augmented) was shown to cause minimal inhibition of the HPA axis when applied 2 times daily for 2 to 3 weeks in healthy subjects and in subjects with psoriasis and eczematous disorders. With 6 g to 7 g of betamethasone dipropionate ointment (augmented) applied once daily for 3 weeks, no significant inhibition of the HPA axis was observed in subjects with psoriasis and atopic dermatitis, as measured by plasma cortisol and 24-hour urinary 17-hydroxy-corticosteroid levels. 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 Opthalmic Adverse Reactions Use of topical corticosteroids, including betamethasone dipropionate ointment (augmented), 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 ointment (augmented) [see ADVERSE REACTIONS ( 6.2 )]. Avoid contact of betamethasone dipropionate ointment (augmented) 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.
Contraindications
Betamethasone dipropionate ointment (augmented) is contraindicated in patients who are hypersensitive to betamethasone dipropionate, to other corticosteroids, or to any ingredient in this preparation. • Hypersensitivity to any component of this medicine. ( 4 )
Adverse Reactions
Most common adverse reactions (<1%) are: erythema, folliculitis, pruritus, and vesiculation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals, Inc. at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 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 ointment (augmented) 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, telangiectasias, burning, irritation, dryness, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, hypertrichosis, striae, 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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