hdrawal of treatment of the topical corticosteroid.
The potential for hypothalamic-pituitary-adrenal (HPA) axis suppression with DUOBRII Lotion was eva luated in a study of 20 adultsubjects with moderate to severe plaque psoriasis involving ≥20% of their body surface area. The subjects were treated once daily for8 weeks and assessed for HPA axis suppression at Weeks 4 and 8. HPA axis suppression occurred in 3 out of 20 (15%) subjects atWeek 4 and none (0%) of these 20 subjects had HPA axis suppression at Week 8 [see Clinical Pharmacology (12.2)].
Because of the potential for systemic absorption, use of topical corticosteroids, including DUOBRII Lotion, may require that patientsbe eva luated periodically for evidence of HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent corticosteroids, use over large surface areas, occlusive use, use on an altered skinbarrier, concomitant use of multiple corticosteroid-containing products, liver failure, and young age. An adrenocorticotropic hormone(ACTH) stimulation test may be helpful in eva luating patients for HPA axis suppression.
If HPA axis suppression is documented, attempt to gradually withdraw the drug or reduce the frequency of application. Manifestationsof adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt andcomplete upon discontinuation of topical corticosteroids.
Systemic effects of topical corticosteroids may also include Cushing's syndrome, hyperglycemia, and glucosuria. Use of more thanone corticosteroid-containing product at the same time may increase the total systemic exposure to topical corticosteroids. Pediatricpatients may be more susceptible than adults to systemic toxicity from the use of topical corticosteroids because of their largersurface-to-body mass ratio [see Use in Specific Populations (8.4)].
5.3 Local Adverse Reactions
Local adverse reactions may include atrophy, striae, telangiectasias, folliculitis and contact dermatitis. Some local adverse reactionsmay be irreversible. If these adverse reactions occur, discontinue the medication at least until the integrity of the skin is restored; donot resume treatment if allergic contact dermatitis is identified.
Avoid use of DUOBRII Lotion on eczematous skin, as it may cause severe irritation.
5.4 Photosensitivity and Risk for Sunburn
Because of heightened burning susceptibility, exposure to sunlight (including sunlamps) should be avoided unless deemed medicallynecessary, and in such cases, exposure should be minimized during the use of DUOBRII Lotion. Patients must be instructed to usesunscreens and protective clothing when using DUOBRII Lotion. Patients with sunburn should be advised not to use DUOBRIILotion until fully recovered. Patients who may have considerable sun exposure due to their occupation and those patients withinherent sensitivity to sunlight should exercise particular caution when using DUOBRII Lotion.
DUOBRII Lotion should be administered with caution if the patient is also taking drugs known to be photosensitizers (e.g., thiazides,tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity.
5.5 Ophthalmic Adverse Reactions
Use of topical corticosteroids may increase the risk of posterior subcapsular cataracts an |
