WYNZORA Cream for Plaque Psoriasis

WYNZORA cream is used for the topical treatment of plaque psoriasis in patients 18 years of age and older.

It is not known if WYNZORA cream is safe to use in patients who are below 18 years of age.

Before using WYNZORA cream, tell your doctor about all of your medical conditions, including if you:

• have a calcium metabolism disorder.

• have skin atrophy (thinning of the skin) present at the treatment site.

• are pregnant or planning to become pregnant. It is not known if WYNZORA cream will harm your unborn baby (ask your doctor).

• are breastfeeding or planning to breastfeed. It is not known if WYNZORA cream can pass into your breast milk (ask your doctor).

• Do not apply WYNZORA cream to the nipple and areola to avoid contact with your baby.

• Tell your healthcare provider about all the medicines you take, including prescriptions, vitamins, over-the-counter medicines, and herbal supplements.

• Apply WYNZORA cream once daily to the affected areas for up to 8 weeks. Rub it in gently to ensure that the plaques are saturated with the cream.

• Do not use WYNZORA cream more than 100 g per week.

• Discontinue treatment when your plaque psoriasis is under control.

• Do not use the cream longer than prescribed.

• Do not use the cream with occlusive dressings unless directed by your doctor.

• Do not use it on the face, groin, or armpits, or if skin atrophy (thinning of the skin) is present at the treatment site.

• Do not use WYNZORA cream in your eyes, mouth, or vagina.

• If you accidentally get WYNZORA cream on your face or in your eyes wash the area with water right away.

• Wash your hands well after applying WYNZORA cream.

Cream: 0.005% calcipotriene and 0.064% betamethasone dipropionate.
Each gram of WYNZORA cream contains 50 mcg of calcipotriene and 0.644 mg of betamethasone
dipropionate in a white cream.

None

Upper respiratory infection, headache, and irritation at the treatment site are some of the common side effects WYNZORA cream has.

Hypercalcemia and hypercalciuria may develop with use the use of topical calcipotriene.

WYNZORA cream can cause reversible Hypothalamic-Pituitary-Adrenal Axis Suppression (HPA) with potential clinical glucocorticosteroid insufficiency. This may occur upon withdrawal of treatment or during treatment. Factors that predispose a patient to HPA axis suppression include the use of occlusive dressings, high-potency steroids, prolonged use, large treatment surface areas, altered skin barrier, liver failure, and young age.

Evaluation for HPA axis suppression will be done by using the adrenocorticotropic hormone (ACTH) stimulation test. If HPA axis suppression is seen, your doctor will gradually withdraw WYNZORA cream, substitute it with a less potent corticosteroid, or reduce the frequency of application.

• thinning of your skin
• dryness
• burning
• changes in skin color
• inflammation
• redness
• itching
• infection
• irritation
• raised bumps on your skin

Cushing’s syndrome and hyperglycemia may occur due to the use of the topical corticosteroid. These complications generally occur after the use of high-potency topical corticosteroids, especially in large doses.

Pediatric patients may have a chance of systemic toxicity due to their larger skin surface-to-body mass ratios. Using more than one corticosteroid-containing product at the same time may increase total systemic corticosteroid exposure.

Allergic contact dermatitis may happen when using a topical corticosteroid so your doctor should conduct appropriate diagnostic patch testing.

Allergic contact dermatitis may happen when using topical calcipotriene so your doctor should conduct appropriate diagnostic patch testing.

Using WYNZORA cream may increase the risks of glaucoma and cataract. Avoid contact with WYNZORA cream with eyes. WYNZORA cream may cause eye irritation. Advise patients to report any visual symptoms and consider visiting an ophthalmologist for evaluation.

Active ingredients: calcipotriene and betamethasone dipropionate
Inactive ingredients: isopropyl myristate, monohydrate, polyoxyl 40 hydrogenated castor oil, carbomer interpolymer (type A), trolamine, mineral oil, medium-chain triglycerides, isopropyl alcohol, polyoxyl lauryl ether, poloxamer (407), dibasic sodium phosphate, butylated hydroxyanisole, heptahydrate, monobasic sodium phosphate, alpha-tocopherol, and purified water

• Store WYNZORA cream at room temperature between 68°F to 77°F (20°C to 25°C) with the cap on the tube tightly closed.

• Do not freeze WYNZORA cream.

• Keep WYNZORA cream out of the light and excessive heat.

• You can throw away WYNZORA cream 6 months after it has been opened.

• Keep WYNZORA cream out of the reach of children.