Important safety information
INDICATION: Wynzora® (calcipotriene and betamethasone dipropionate) Cream, 0.005%/0.064% is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older. ADVERSE EVENTS: In the pivotal trial, the most common adverse reactions (≥1%) were: upper respiratory infection (7%), headache (2%), and application site infection (1%). WARNINGS AND PRECAUTIONS: For topical use only. Patients should not use more than 100g of Wynzora® Cream per week. Do not use near or in the mouth, eyes or intravaginally. Avoid using Wynzora® Cream on the face, groin or armpits, or if they have atrophy at the treatment site. Discontinue use once plaque psoriasis is under control or at 8 weeks. Do not use Wynzora® Cream with occlusive dressings. Hypercalcemia and hypercalciuria have been observed with topical use of calcipotriene. Wynzora® Cream can cause reversible HPA axis suppression with the potential for clinical glucocorticosteroid insufficiency during and after withdrawal of treatment. Wynzora® Cream may cause vision problems, including increasing the risk of cataracts and glaucoma. It is not known if Wynzora® Cream may harm your unborn baby. Breastfeeding women should not apply Wynzora® Cream directly to the nipple or areola; it is not known whether topically administered calcipotriene and betamethasone dipropionate is absorbed in human milk.
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