SUMMARY
Halobetasol is a lipocortin corticosteroid used to treat inflammatory and pruritic corticosteroid-responsive dermatoses.
Halobetasol is a highly potent corticosteroid. It is structurally related to clobetasol. Due to its high potency, it is mainly prescribed in the treatment of severe plaque psoriasis and corticosteroid responsive dermatoses.
INDICATIONS & USAGE
- ULTRAVATE® lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.
CONTRAINDICATIONS
None.
WARNINGS AND PRECAUTIONS
- Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. Systemic absorption may require evaluation for HPA axis suppression.
- Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. Use of potent corticosteroids on large areas, for prolonged durations, under occlusive dressings, or on an altered skin barrier may increase systemic exposure.
- Children may be more susceptible to systemic toxicity when treated with topical corticosteroids.
- Local adverse reactions with topical steroids may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis. Adverse reactions may be more likely to occur with occlusive use or more potent corticosteroids.
- Topical corticosteroids may increase the risk of cataract and glaucoma formation. If visual symptoms occur, consider referral to an ophthalmologist tor evaluation.
- Initiate appropriate therapy if concomitant skin infections develop.
ADVERSE REACTIONS
The most commonly reported adverse reactions (≥1%) are telangiectasia, application site atrophy, and headache.
To report SUSPECTED ADVERSE REACTIONS, contact Lacer Pharma, LLC at 1-888-403-8874 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Full Prescribing Information: DailyMed
