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Calcipotriene 0.005% And Betamethasone Dipropionate 0.064% Ointment Recall
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment is indicated for the topical treatment of psoriasis vulgaris in adults 18 years of age and older.
- Calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment should not be applied to the face, axillae or groin.
- Calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment should not be used if there is skin atrophy at the treatment site.
History
There is currently no drug history available for this drug.
Other Information
Calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment contains calcipotriene and betamethasone dipropionate.
It is intended for topical use only.
Calcipotriene is a synthetic vitamin D3 analog.
Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1(α),3(β),24-triol, with the empirical formula C27H40O3, a molecular weight of 412.3, and the following structural formula:
Calcipotriene is a white to almost white crystalline compound.
Betamethasone dipropionate is a synthetic corticosteroid.
Betamethasone dipropionate has the chemical name 9-fluoro-11(β),17,21-trihydroxy-16(β)-methylpregna-1,4-diene-3,20-dione17,21-dipropionate, with the empirical formula C28H37FO7, a molecular weight of 504.6, and the following structural formula:
Betamethasone dipropionate is a white to almost white odorless powder.
Each gram of calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment contains 50 mcg of calcipotriene and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in off-white to yellow paraffin ointment base of caprylic/capric triglycerides, diazolidinyl urea, dl-alpha tocopherol and white petrolatum.
Sources
Calcipotriene 0.005% And Betamethasone Dipropionate 0.064% Ointment Manufacturers
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Sandoz Inc.
Calcipotriene 0.005% And Betamethasone Dipropionate 0.064% Ointment | Sandoz Inc.
Apply an adequate layer of calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment to the affected area(s) once daily for up to 4 weeks. The maximum weekly dose should not exceed 100 g. Treatment of more than 30% body surface area is not recommended. Calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment should be rubbed in gently and completely. Patients should wash their hands after applying calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment.
Calcipotriene 0.005% and betamethasone dipropionate 0.064% ointment is not for oral, ophthalmic, or intravaginal use.
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