warnings and cautions
5 WARNINGS AND PRECAUTIONS Enter section text here Hypercalcemia and hypercalciuria have been reported. If either occurs, discontinue until parameters of calcium metabolism normalize ( 5.1 ) Topical corticosteroids can produce reversible HPA axis suppression, Cushing's syndrome and unmask latent diabetes ( 5.2 ) Rate of adrenal suppression increased with treatment duration ( 5.2 ) Systemic absorption may require evaluation for hypothalamic-pituitary-adrenal (HPA) axis suppression ( 5.2 ) Modify use should HPA axis suppression develop ( 5.2 ) Potent corticosteroids, use on large areas, prolonged use or occlusive use may increase systemic absorption ( 5.1 ) Local adverse reactions may include atrophy, striae, irritation, acneiform eruptions, hypopigmentation, and allergic contact dermatitis and may be more likely with occlusive use or more potent corticosteroids ( 5.3 , 6.1 ) Children may be more susceptible to systemic toxicity when treated with topical corticosteroids ( 5.2 , 8.4 ) 5.1 Effects on Calcium Metabolism Hypercalcemia and hypercalciuria have been observed with use of Taclonex Scalp ® Topical Suspension. If hypercalcemia or hypercalciuria develop, treatment should be discontinued until parameters of calcium metabolism have normalized. The effects of Taclonex Scalp ® Topical Suspension on calcium metabolism following treatment durations of more than 8 weeks have not been evaluated. 5.2 Effects on Endocrine System Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for clinical glucocorticosteroid insufficiency. This may occur during treatment or upon withdrawal of the topical corticosteroid. In a study of 32 subjects treated with Taclonex Scalp ® Topical Suspension on the scalp and Taclonex ® Ointment on the body, adrenal suppression was identified in 5 of 32 subjects (15.6%) after 4 weeks of treatment and in 2 of 11 subjects (18.2%) who continued treatment for 8 weeks. [ See CLINICAL PHARMACOLOGY Pharmacodynamics ( 12.2 ) ] Because of the potential for systemic absorption, use of topical corticosteroids may require that patients be periodically evaluated for HPA axis suppression. Factors that predispose a patient using a topical corticosteroid to HPA axis suppression include the use of more potent steroids, use over large surface areas, use over prolonged periods, use under occlusion, use on an altered skin barrier, and use in patients with liver failure. An ACTH stimulation test may be helpful in evaluating patients for HPA axis suppression. If HPA axis suppression is documented, an attempt should be made to gradually withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid. Manifestations of adrenal insufficiency may require supplemental systemic corticosteroids. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Cushing’s syndrome, hyperglycemia, and unmasking of latent diabetes mellitus can also result from systemic absorption of topical corticosteroids. Use of more than one corticosteroid-containing product at the same time may increase the total systemic corticosteroid exposure. Pediatric patients may be more susceptible to systemic toxicity from use of topical corticosteroids. [ See Use in Specific Populations ( 8.4 ) ] 5.3 Local Adverse Reactions with Topical Corticosteroids Local adverse reactions may be more likely to occur with occlusive use, prolonged use or use of higher potency corticosteroids. Reactions may include atrophy, striae, telangiectasias, burning, itching, irritation, dryness, folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, secondary infection, and miliaria. Some local adverse reactions may be irreversible. 5.4 Allergic Contact Dermatitis with Topical Corticosteroids Allergic contact dermatitis to any component of topical corticosteroids is usually diagnosed by a failure to heal rather than a clinical exacerbation. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. 5.5 Allergic Contact Dermatitis with Topical Calcipotriene Allergic contact dermatitis has been observed with use of topical calcipotriene. Clinical diagnosis of allergic contact dermatitis can be confirmed by patch testing. 5.6 Concomitant Skin Infections Concomitant skin infections should be treated with an appropriate antimicrobial agent. If the infection persists, Taclonex Scalp ® Topical Suspension should be discontinued until the infection has been adequately treated. 5.7 Unevaluated Uses The safety and efficacy of Taclonex Scalp ® Topical Suspension in patients with known or suspected disorders of calcium metabolism have not been evaluated. The safety and efficacy of Taclonex Scalp ® Topical Suspension in patients with erythrodermic, exfoliative or pustular psoriasis have not been evaluated. The safety and efficacy of Taclonex Scalp ® Topical Suspension in patients with severe renal insufficiency or severe hepatic disorders have not been evaluated. 5.8 Eye Exposures Avoid eye exposures. Taclonex Scalp ® Topical Suspension may cause eye irritation. 5.9 Ultraviolet Light Exposures Patients who apply Taclonex Scalp ® Topical Suspension to exposed skin (e.g. a bald scalp) should avoid excessive exposure to either natural or artificial sunlight, including tanning booths, sun lamps, etc. Physicians may wish to limit or avoid use of phototherapy to the scalp in patients who use Taclonex Scalp ® Topical Suspension.