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Calcipotriene And Betamethasone Dipropionate 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
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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 for up to 4 weeks.
- 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 hydrate and betamethasone dipropionate. It is intended for topical use.
Calcipotriene hydrate is a synthetic vitamin D3 analogue.
Chemically, calcipotriene hydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1(alpha),3(beta),24-triol,hydrate, with the empirical formula C27H40O3H2O, a molecular weight of 430.6, and the following structural formula:
Calcipotriene hydrate is a white to almost white crystalline compound.
Betamethasone dipropionate is a synthetic corticosteroid.
Betamethasone dipropionate has the chemical name 9-fluoro-11(beta),17,21-trihydroxy-16(beta)-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 52.18 mcg of calcipotriene hydrate (equivalent to 50 mcg of calcipotriene) and 0.643 mg of betamethasone dipropionate (equivalent to 0.5 mg of betamethasone) in an ointment base of mineral oil, PPG-15 stearyl ether, dl-alpha tocopherol and white petrolatum.
Sources
Calcipotriene And Betamethasone Dipropionate Ointment Manufacturers
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Perrigo New York Inc
Calcipotriene And Betamethasone Dipropionate Ointment | Perrigo New York 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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