Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Calcipotriene ointment, 0.005% is available in: 60 gram aluminum tube NDC (51672-4154-3) 120 gram aluminum tube NDC (51672-4154-4); PRINCIPAL DISPLAY PANEL - 120 g Tube Carton NDC 51672-4154-4 120 g Calcipotriene Ointment 0.005% FOR TOPICAL DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 120 g Tube Carton
- HOW SUPPLIED Calcipotriene ointment, 0.005% is available in: 60 gram aluminum tube NDC (51672-4154-3) 120 gram aluminum tube NDC (51672-4154-4)
- PRINCIPAL DISPLAY PANEL - 120 g Tube Carton NDC 51672-4154-4 120 g Calcipotriene Ointment 0.005% FOR TOPICAL DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE. Rx only Keep this and all medications out of the reach of children. TARO PRINCIPAL DISPLAY PANEL - 120 g Tube Carton
Overview
Calcipotriene ointment, 0.005% contains the compound calcipotriene, a synthetic vitamin D 3 derivative for topical dermatological use. Chemically, calcipotriene is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola- 5,7,10(19),22-tetraene-1α,3β,24-triol-, with the empirical formula C 27 H 40 O 3 , a molecular weight of 412.6, and the following structural formula: Calcipotriene is a white or off-white crystalline substance. Calcipotriene ointment contains calcipotriene 50 μg/g in an ointment base of disodium phosphate dihydrate, edetate disodium, mineral oil, petrolatum, propylene glycol, α-tocopherol, steareth-2 and purified water. Structural Formula of Calcipotriene
Indications & Usage
Calcipotriene ointment, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
Dosage & Administration
Apply a thin layer of calcipotriene ointment once or twice daily and rub in gently and completely.
Warnings & Precautions
No warnings available yet.
Contraindications
Calcipotriene is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity. Calcipotriene should not be used on the face.
Adverse Reactions
In controlled clinical trials, the most frequent adverse reactions reported for calcipotriene were burning, itching and skin irritation, which occurred in approximately 10-15% of patients. Erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis including development of facial/scalp psoriasis were reported in 1 to 10% of patients. Other experiences reported in less than 1% of patients included skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis. Once daily dosing has not been shown to be superior in safety to twice daily dosing.
Storage & Handling
STORAGE Store at controlled room temperature 15°C-25°C (59°F-77°F). Do not freeze. Manufactured by: Glenmark Generics Ltd. Colvale-Bardez, Goa 403 513, India Distributed by: Taro Pharmaceuticals U.S.A., Inc. Hawthorne, NY 10532 November 2011
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