Wynzora
- Generic Name: calcipotriene and betamethasone dipropionate cream
- Brand Name: Wynzora
Wynzora (Calcipotriene and Betamethasone Dipropionate Cream) side effects drug center
Wynzora Side Effects Center
What Is Wynzora?
Wynzora (calcipotriene and betamethasone dipropionate cream) is a combination of a vitamin D analog and a corticosteroid used for the topical treatment of plaque psoriasis in patients 18 years of age and older.
What Are Side Effects of Wynzora?
Side effects of Wynzora include:
- upper respiratory infection,
- headache, and
- application site irritation
Dosage for Wynzora
The dose of Wynzora Cream is to apply to affected areas once daily for up to 8 weeks. Do not use more than 100 g per week.
Wynzora In Children
Safety and effectiveness of the use of Wynzora Cream in adolescents and pediatric patients under the age of 18 years have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of systemic toxicity when treated with topical corticosteroids. Pediatric patients are, therefore, also at greater risk of HPA axis suppression and adrenal insufficiency with the use of topical corticosteroids including Wynzora Cream.
Systemic toxicities such as Cushing's syndrome, linear growth retardation, delayed weight gain, and intracranial hypertension have been reported in pediatric patients, especially those with prolonged exposure to large doses of high potency topical corticosteroids. Local adverse reactions including striae have also been reported with use of topical corticosteroids in pediatric patients.
What Drugs, Substances, or Supplements Interact with Wynzora?
Wynzora may interact with other medicines.
Tell your doctor all medications and supplements you use.
Wynzora During Pregnancy and Breastfeeding
Tell your doctor if you are pregnant or plan to become pregnant before using Wynzora; it is unknown how it would affect a fetus. It is unknown if topically administered Wynzora could result in sufficient systemic absorption to produce detectable quantities in breast milk. Consult your doctor before breastfeeding.
Additional Information
Our Wynzora (calcipotriene and betamethasone dipropionate cream) for Topical Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Wynzora Professional Information
SIDE EFFECTS
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The rates of adverse reactions given below were reported in a randomized, multicenter, prospective, vehicle and active controlled clinical trial in adult subjects with plaque psoriasis. Subjects applied WYNZORA® Cream, calcipotriene/betamethasone dipropionate topical suspension, 0.005%/0.064% or vehicle once daily for 8 weeks. The mean weekly dose of WYNZORA® Cream was 33.8 g. A total of 342 subjects were treated with WYNZORA® Cream, 337 with calcipotriene/betamethasone dipropionate topical suspension, 0.005%/0.064% and 115 with vehicle. The majority of subjects were White (87%) and male (62%). Approximately 72% were non-Hispanic/Latino. The mean age was 52 years and ages ranged from 18 to 89 years.
The most common adverse reactions reported by ≥1% of subjects treated with WYNZORA® Cream and more frequently than vehicle are presented in Table 1 below.
Table 1: Adverse Reactions Through Week 8
| Preferred Term | WYNZORA® Cream (N=342) |
Vehicle Cream (N=115) |
| Upper Respiratory Infection (URI)* | 7% | 5% |
| Headache | 2% | 0% |
| Application site irritation | 1% | 0% |
| *Includes nasopharyngitis, upper respiratory tract infection (URTI), and viral URTI | ||
Postmarketing Experience
The following adverse reactions have been identified during post-approval use of topical corticosteroids. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Postmarketing reports for local adverse reactions to topical corticosteroids included: atrophy, striae, telangiectasias, itching, dryness, hypopigmentation, perioral dermatitis, secondary infection, and miliaria.
Ophthalmic adverse reactions of cataracts, glaucoma, and increased intraocular pressure, have been reported during use of topical corticosteroids, including topical betamethasone products.
DRUG INTERACTIONS
No Information Provided
Read the entire FDA prescribing information for Wynzora (Calcipotriene and Betamethasone Dipropionate Cream)
&Copy; Wynzora Patient Information is supplied by Cerner Multum, Inc. and Wynzora Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.