Drug Catalog - Product Detail
CALCIPOTRIENE-BETAMETHASONE DIPROPIONATE OINTMENT OINT 0.005%/0.064% 100GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 45802-0989-01 | PADAGIS | 100 | 0.005-0.064% | OINTMENT |
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Description
11 DESCRIPTION Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% contains calcipotriene hydrate and betamethasone dipropionate. It is intended for topical use only. Calcipotriene hydrate is a synthetic vitamin D 3 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 C 27 H 40 O 3 H 2 O, 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 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 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 off-white to yellow paraffin ointment base of butylhydroxytoluene, mineral oil, polyoxypropylene stearyl ether, all-rac-alpha-tocopherol, and white petrolatum. Calcipotriene hydrate structure betamethasone dipropionate structure
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment is off-white to yellow in color, available in collapsible tubes of: 60 gram (NDC 45802-989-96) 100 gram (NDC 45802-989-01) 16.2 Storage Store Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment between 20°C - 25°C (68°F - 77°F); excursions permitted between 15°C - 30°C (59°F - 86°F). [See USP controlled room temperature.] 16.3 Handling Keep out of reach of children.
Indications & Usage
1 INDICATIONS AND USAGE Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% Ointment is indicated for the topical treatment of plaque psoriasis in patients 12 years of age and older. Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% 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 AND ADMINISTRATION 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. 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. 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 0.005% and Betamethasone Dipropionate 0.064% 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 0.005% and Betamethasone Dipropionate 0.064% Ointment is not for oral, ophthalmic, or intravaginal use. • Apply Calcipotriene 0.005% and Betamethasone Dipropionate 0.064% 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)