Active Ingredients in Wynzora Cream
Each gram of Wynzora Cream contains 50 mcg of calcipotriene and 0․644 mg of betamethasone dipropionate․ The cream is indicated for the topical treatment of plaque psoriasis in patients 18 years of age and older․
Calcipotriene
Calcipotriene, a synthetic vitamin D3 analog, is one of the active ingredients in Wynzora Cream․ Each gram of the cream contains 50 mcg of calcipotriene․ This compound plays a crucial role in the topical treatment of plaque psoriasis by regulating skin cell growth and development․ Calcipotriene is a white powder that is insoluble in water but soluble in ethanol․ Its chemical formula is C27H40O3 with a molecular weight of 412․6․
Betamethasone Dipropionate
Betamethasone dipropionate, a synthetic corticosteroid, is the second active ingredient in Wynzora Cream․ Each gram of the cream contains 0․644 mg of betamethasone dipropionate, which is equivalent to 0․5 mg of betamethasone․ This compound exerts anti-inflammatory and immunosuppressive effects, playing a vital role in the treatment of plaque psoriasis․ Betamethasone dipropionate is a white to almost white crystalline powder that is practically insoluble in water, freely soluble in acetone, and sparingly soluble in alcohol․
Inactive Ingredients in Wynzora Cream
Wynzora Cream contains inactive ingredients such as isopropyl myristate, mineral oil, medium-chain triglycerides, isopropyl alcohol, polyoxyl lauryl ether, poloxamer (407), polyoxyl 40 hydrogenated castor oil, carbomer interpolymer (type A), butylated hydroxyanisole, trolamine, dibasic sodium phosphate, heptahydrate, monobasic sodium phosphate, and alpha-tocopherol․ These inactive ingredients serve various functions in the formulation of the cream․
Isopropyl Myristate
Isopropyl myristate is one of the inactive ingredients in Wynzora Cream․ This compound serves as an excipient in the formulation․ Isopropyl myristate may have specific properties that contribute to the overall characteristics of the cream, although it does not have an active role in treating plaque psoriasis․ It is essential to consider the presence of inactive ingredients for overall product evaluation and potential allergic reactions․
Mineral Oil
Mineral oil is an inactive ingredient present in Wynzora Cream․ It serves a role in the formulation of the cream, contributing to its overall characteristics․ In the cream, mineral oil is utilized for specific purposes that aid in the application and effectiveness of the product․ Understanding the function of mineral oil in the cream is essential for a comprehensive evaluation of its composition․
Medium-chain Triglycerides
Medium-chain triglycerides are among the inactive ingredients present in Wynzora Cream․ These triglycerides serve various functions in the formulation, contributing to the overall characteristics of the cream․ While they do not play an active role in treating plaque psoriasis, their inclusion in the cream formulation is essential for stability and other product qualities․
FDA Approval and Clinical Trials
Wynzora Cream, containing calcipotriene and betamethasone dipropionate, received FDA approval on July 22, 2020, for the treatment of plaque psoriasis in adults․ Clinical trials conducted to evaluate the safety and efficacy of Wynzora Cream involved randomized, multicenter studies in adult patients with plaque psoriasis․ The trials included comparisons with vehicle creams and active comparators, demonstrating the cream’s effectiveness and safety profile․
FDA Approval of Wynzora Cream
Wynzora Cream, containing calcipotriene and betamethasone dipropionate, received FDA approval on July 22, 2020, for the topical treatment of plaque psoriasis in adults aged 18 years and older․ This approval marked a significant milestone in providing an effective treatment option for individuals with plaque psoriasis․ Clinical trials supported the safety and efficacy of Wynzora Cream, leading to its regulatory approval․
Safety and Efficacy Trials
Regarding safety and efficacy, clinical trials assessed Wynzora Cream in adult patients with mild-to-moderate plaque psoriasis․ A randomized, multicenter trial showed promising results․ Patients were grouped into treatment arms, comprising Wynzora Cream, vehicle cream, and active comparator for comparison․ Safety and efficacy outcomes favored Wynzora Cream, affirming its positive risk-benefit profile․
Dosage and Administration
Apply WYNZORA Cream to affected areas once daily for up to 8 weeks․ Rub in gently to saturate the plaques․ Use not more than 100 grams per week․ Discontinue when the condition is controlled․ Avoid oral, ophthalmic, or intravaginal use․
Application Instructions
Apply Wynzora Cream once daily to the affected areas for up to 8 weeks, ensuring gentle saturation of the plaques․ It is crucial not to exceed 100 grams per week․ Patients should discontinue treatment upon achieving control over plaque psoriasis, unless otherwise directed by a healthcare provider․ Remember, Wynzora Cream is solely for topical use on the skin․
Dosage Guidelines
For optimal use, apply Wynzora Cream once daily to affected areas for a maximum of 8 weeks․ The application should be gentle to ensure complete saturation of the plaques․ It is important not to exceed the weekly usage limit of 100 grams․ Patients are advised to discontinue treatment once the condition is under control٫ unless otherwise directed by a healthcare provider․ Remember٫ Wynzora Cream is suitable for topical use only․
Side Effects and Interactions
Wynzora Cream may cause side effects such as excess calcium, adrenal gland effects, hyperglycemia, skin issues, and eye problems․ It’s crucial to apply Wynzora Cream properly, limiting usage to avoid adverse reactions․ Always consult a healthcare provider for guidance on potential interactions with other medications․
Common Adverse Reactions
Common adverse reactions associated with Wynzora Cream include excess calcium levels, effects on the adrenal glands, hyperglycemia, skin issues, and eye problems․ It is important to be aware of these potential side effects and seek medical advice if you experience any concerning symptoms while using Wynzora Cream․ Adherence to dosage guidelines and proper application techniques can help minimize adverse reactions․
Potential Drug Interactions
When using Wynzora Cream, it’s crucial to consider potential drug interactions․ Inform your healthcare provider about all medications and supplements you are currently taking to avoid any adverse interactions․ Certain medications may interact with Wynzora Cream, impacting its effectiveness or increasing the risk of side effects․ Healthcare professionals can provide guidance on managing potential drug interactions while using Wynzora Cream․
It is essential to follow specific precautions with the use of Wynzora Cream․ Ensure that the cream is not frozen and protected from excessive heat and light․ Dispose of any unused cream after six months of opening the tube․ Keep Wynzora Cream out of reach of children and avoid contact with mucous membranes and eyes․ Specific care must be taken in pediatric patients and during pregnancy or breastfeeding․
Special Precautions and Considerations
When using Wynzora Cream, specific precautions must be observed․ It is crucial to store the cream at temperatures between 20°C-25°C, protecting it from freezing, light, and excessive heat․ Unused cream should be discarded six months after opening the tube․ Keep Wynzora Cream out of children’s reach and avoid contact with mucous membranes and eyes․ Extra caution should be taken when using in pediatric patients and during pregnancy or breastfeeding․
Pregnancy and Breastfeeding
During pregnancy, the safety of Wynzora Cream is not established․ It is unknown how the cream may affect a developing fetus․ Consult a healthcare provider if you are pregnant or planning pregnancy before using Wynzora Cream․ Additionally, it is unclear if the topical administration of Wynzora Cream can lead to detectable quantities in breast milk․ Consult with a healthcare professional before using Wynzora Cream while breastfeeding․
Storage and Handling Information
It is important to follow proper storage guidelines for Wynzora Cream․ Store the cream between 20°C-25°C (68°F-77°F) with excursions permitted between 15°C-30°C (59°F-86°F)․ Avoid freezing the cream and protect it from light and excessive heat․ Discard any unused product six months after opening the tube․ For safekeeping, keep Wynzora Cream out of the reach of children․
Storage Conditions
Wynzora Cream should be stored between 20°C-25°C (68°F-77°F) with excursions permitted between 15°C-30°C (59°F-86°F)․ Avoid freezing the cream and protect it from light and excessive heat․ It is recommended to discard any unused product six months after opening the tube․ Keep Wynzora Cream out of the reach of children to ensure safety․
Proper Disposal Guidelines
For proper disposal of Wynzora Cream, it is recommended to discard any unused product six months after opening the tube․ Ensure that the cream is not exposed to extreme temperatures, freezing, or direct light․ To maintain safety, keep Wynzora Cream out of the reach of children․ It is essential to follow these disposal guidelines to prevent misuse or accidental exposure to the cream․
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