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Drug Catalog - Product Detail

CALCIPOTRIENE-BETAMETH DIPROP OINT 0.005-0.064% 100GM

NDC Mfr Size Str Form
00781-7165-95 SANDOZ 100 0.005-0.064% OINTMENT
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Generic Name
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
Substance Name
BETAMETHASONE DIPROPIONATE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA201615
Description
11 DESCRIPTION Calcipotriene and betamethasone dipropionate ointment contains calcipotriene and betamethasone dipropionate. It is intended for topical use only. Calcipotriene is a synthetic vitamin D 3 analogue. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19), 22-tetraene-1(alpha),3(beta),24-triol, with the molecular formula C 27 H 40 O 3 , 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(beta),17,21-trihydroxy-16(beta)-methylpregna-1,4-diene-3,20-dione17,21-dipropionate, with the molecular formula C 28 H 37 FO 7 , 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 and betamethasone dipropionate 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, all-rac-alpha-tocopherol and white petrolatum. 3339d333-figure-01 3339d333-figure-02
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Calcipotriene and betamethasone dipropionate ointment is off-white to yellow in color, available in collapsible tubes of: 60 gram (NDC 0781-7165-35) 100 gram (NDC 0781-7165-95) 16.2 Storage Store calcipotriene and betamethasone dipropionate ointment at 20º to 25°C (68º to 77°F); excursions permitted between 15º to 30°C (59º to 86°F) [see USP Controlled Room Temperature]. 16.3 Handling Keep out of the reach of children.
Indications & Usage
1 INDICATIONS & USAGE Calcipotriene and betamethasone dipropionate ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. Calcipotriene and betamethasone dipropionate ointment is a vitamin D analogue and corticosteroid combination product indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. ( 1 )
Dosage and Administration
2 DOSAGE & ADMINISTRATION Apply an adequate layer of calcipotriene and betamethasone dipropionate ointment to the affected area(s) once daily for up to 4 weeks. Calcipotriene and betamethasone dipropionate ointment should be rubbed in gently and completely. Patients should wash their hands after applying calcipotriene and betamethasone dipropionate ointment. Therapy should be discontinued when control is achieved. Patients 18 years and older should not use more than 100 g per week and patients 12 to 17 years should not use more than 60 g per week. Treatment of more than 30% body surface area is not recommended. Calcipotriene and betamethasone dipropionate ointment should not be used with occlusive dressings unless directed by a physician. Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. Calcipotriene and betamethasone dipropionate ointment is not for oral, ophthalmic, or intravaginal use. Apply calcipotriene and betamethasone dipropionate ointment to affected area(s) once daily for up to 4 weeks. Discontinue therapy when control is achieved. ( 2 ) Adult patients should not use more than 100 g per week. ( 2 ) Patients ages 12 to 17 years should not use more than 60 g per week. ( 2 ) Treatment of more than 30% body surface area is not recommended. ( 2 ) Do not use with occlusive dressings unless directed by a physician. ( 2 ) Avoid use on the face, groin, or axillae, or if skin atrophy is present at the treatment site. ( 2 ) Not for oral, ophthalmic, or intravaginal use. ( 2 )