Ultravate

ULTRAVATE lotion is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. ULTRAVATE lotion is a corticosteroid indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. ( 1 )

None. None.

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. (5.1) 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.

(5.1) Children may be more susceptible to systemic toxicity when treated with topical corticosteroids. (5.1, 8.4) 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. (5.2, 5.5) Topical corticosteroids may increase the risk of cataract and glaucoma formation.

If visual symptoms occur, consider referral to an ophthalmologist tor evaluation. (5.3) Initiate appropriate therapy if concomitant skin infections develop. (5.4)

5.1Effects on Endocrine System

ULTRAVATE lotion has been shown to suppress the hypothalamic-pituitary-adrenal (HPA) axis.Systemic effects of topical corticosteroids may include reversible HPA axis suppression, with the potential for glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of treatment of the topical corticosteroid.The potential for hypothalamic-pituitary adrenal (HPA) suppression with ULTRAVATE lotion was evaluated in the following studies: In a study of 20 adult subjects with moderate to severe plaque psoriasis involving 􀃙20% of their body surtace area.

ULTRAVATE lotion produced HPA axis suppression when used twice daily for two weeks in 5 out of 20 (25%) adult subjects with plaque psoriasis. The effects of HPA axis suppression were reversible on discontinuation of the treatment [see Clinical Pharmacology (12.2)] . In another clinical study, 16 adolescent subjects (12 to less than 17 years old) with moderate to severe plaque psoriasis involving 10% or more of their body surtace area applied a maximum of approximately 50 grams of ULTRAVATE lotion to affected areas twice daily for two weeks.