For: Plaque Psoriasis
Bryhali (halobetasol propionate) is a high-potency topical corticosteroid formulation for the treatment of plaque psoriasis in adults. BRYHALI (halobetasol propionate) lotion, 0.01% is a white to off-white lotion supplied in a white aluminum tube as follows:
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60 g (NDC 0187-0002-60)
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100 g (NDC 0187-0002-01)
Storage and Handling Conditions
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]. Protect from freezing. These highlights do not include all the information needed to use BRYHALI safely and effectively. See full prescribing information for BRYHALI.
BRYHALI� (halobetasol propionate) lotion, for topical use
Initial U.S. Approval: 1990
INDICATIONS AND USAGE
BRYHALI lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in adults. (1)
DOSAGE AND ADMINISTRATION
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Apply a thin layer of BRYHALI Lotion to the affected areas once daily. (2)
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Treatment beyond 8 weeks is not recommended. Discontinue treatment if control is achieved before 8 weeks. (2)
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Do not use with occlusive dressings unless directed by a physician. (2)
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Avoid use on the face, groin, or axillae. (2)
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Not for oral, ophthalmic, or intravaginal use. (2)
DOSAGE FORMS AND STRENGTHS
Lotion, 0.01% (3)
Each gram of BRYHALI Lotion contains 0.1 mg (0.01%) halobetasol propionate. (3)
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
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Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression was observed and may occur with the potential for glucocorticosteroid insufficiency during or after treatment. (5.1)
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Systemic effects of topical corticosteroids may also include Cushing�s syndrome, hyperglycemia, and glucosuria. (5.1)
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Systemic absorption may require evaluation for HPA axis suppression. (5.1)
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Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure. (5.1)
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Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4)
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Local adverse reactions may include atrophy, striae, telangiectasias, hypopigmentation, and allergic contact dermatitis. Some local adverse reactions may be irreversible. (5.2)
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Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts and glaucoma. If visual symptoms occur, consider referral to an ophthalmologist for evaluation. (5.3)
ADVERSE REACTIONS
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The most common adverse reactions (?1%) were upper respiratory tract infection, application site dermatitis and hyperglycemia. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health Americas, Inc. at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
