Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED Calcipotriene Ointment, 0.005% is available in: 60 gram aluminum tubes NDC 66993-878-61 120 gram aluminum tubes NDC 66993-878-78; PRINCIPAL DISPLAY PANEL - 60 g Tube Carton NDC 66993-878-61 NET WT. 60 g PRASCO Calcipotriene Ointment, 0.005% Rx only PRINCIPAL DISPLAY PANEL - 60 g Tube Carton; PRINCIPAL DISPLAY PANEL - 120 g Tube Carton PRASCO NDC 66993-878-78 NET WT. 120 g Calcipotriene Ointment, 0.005% Rx only PRINCIPAL DISPLAY PANEL - 120 g Tube Carton
- HOW SUPPLIED Calcipotriene Ointment, 0.005% is available in: 60 gram aluminum tubes NDC 66993-878-61 120 gram aluminum tubes NDC 66993-878-78
- PRINCIPAL DISPLAY PANEL - 60 g Tube Carton NDC 66993-878-61 NET WT. 60 g PRASCO Calcipotriene Ointment, 0.005% Rx only PRINCIPAL DISPLAY PANEL - 60 g Tube Carton
- PRINCIPAL DISPLAY PANEL - 120 g Tube Carton PRASCO NDC 66993-878-78 NET WT. 120 g Calcipotriene Ointment, 0.005% Rx only 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 dibasic sodium phosphate, edetate disodium, mineral oil, petrolatum, propylene glycol, tocopherol, steareth-2 and water. calcipotriene structure
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
WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of Calcipotriene Ointment.
Contraindications
Calcipotriene Ointment 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 Ointment should not be used on the face.
Adverse Reactions
Clinical Trials Experience In controlled clinical trials, the most frequent adverse reactions reported for Calcipotriene Ointment 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. Postmarketing Experience Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions associated with the use of Calcipotriene Ointment have been identified post-approval: contact dermatitis, including allergic contact dermatitis.
Storage & Handling
STORAGE Store at controlled room temperature 15°C-25°C (59°F-77°F). Do not freeze.
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