Safety Profile

Class 1 topical corticosteroid

In a clinical study, ULTRAVATE® Lotion (halobetasol propionate, 0.05%) was WELL-TOLERATED with a low rate of adverse reactions1

The most common adverse reactions were telangiectasia, application site atrophy, and headache, which each occurred in 1% of patients.1

Burning/stinging occurred in less than 1% of patients.1

Local adverse reactions with topical steroids may include atrophy, striae, telangiectasia, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection and miliaria. These may be more likely to occur with occlusive use, prolonged use or more potent corticosteroids, including ULTRAVATE®.1

See 2-Week Patient Results

Established Safety in Ages 12 And Up1

ULTRAVATE® Lotion was found to be safe in adolescent patients treated twice daily for 2 weeks.1

No HPA axis suppression occurring in 93% of adolescent patients.1

Because of higher skin surface area to body mass ratios, pediatric patients are at a greater risk than adults of HPA axis suppression and Cushing’s syndrome when they are treated with topical corticosteroids. They are therefore also at greater risk of adrenal insufficiency during or after withdrawal of treatment. Adverse reactions including striae have been reported with use of topical corticosteroids in infants and children.1


HPA axis suppression, Cushing’s syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels and an absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema. Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency.1


Local adverse reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection and miliaria. These may be more likely to occur with occlusive use, prolonged use or more potent corticosteroids, including ULTRAVATE®.1

View Patient Savings
References: 1. ULTRAVATE® Lotion [prescribing information]. Cranbury, NJ: Sun Pharmaceutical Industries, Inc.; 2017. 2. National Psoriasis Foundation. Topical steroid potency chart. https://www.psoriasis.org/about-psoriasis/treatments/topicals/steroids/potency-chart. Accessed October 31, 2019.
INDICATIONS AND USAGE

ULTRAVATE (halobetasol propionate) Lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older.

IMPORTANT SAFETY INFORMATION

Usage: Limit use to 50 g/week. Discontinue treatment when control is achieved. If no improvement is seen within 2 weeks, reassess diagnosis. Treatment beyond 2 consecutive weeks is not recommended. Avoid use on the face, scalp, groin, or axillae.

Effects on Endocrine System: Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression may occur, with the potential for glucocorticosteroid insufficiency during or after treatment. Systemic effects of topical corticosteroids may also include Cushing’s syndrome, hyperglycemia, and glucosuria. Systemic absorption may require evaluation for HPA axis suppression. 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 steroids.

Local Adverse Reactions: Local adverse reactions with topical steroids may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection and miliaria. These may be more likely to occur with occlusive use, prolonged use or more potent corticosteroids, including ULTRAVATE.

Concomitant Skin Infections: Use an appropriate antimicrobial agent if a skin infection is present or develops.

Allergic Contact Dermatitis: Discontinue ULTRAVATE Lotion if allergic contact dermatitis is established.

In clinical trials the most common adverse reactions (≥1%) were telangiectasia, application site atrophy, and headache.

To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Full Prescribing Information for complete prescribing details.