Calcipotriene

INDICATIONS AND USAGE Calcipotriene ointment USP, 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 AND ADMINISTRATION Apply a thin layer of calcipotriene ointment USP, 0.005% once or twice daily and rub in gently and completely.

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 were burning, itching and skin irritation, which occurred in approximately 10 to 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 The following adverse reactions have been identified during post approval use of Dovonex Ointment. 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. Renal and urinary disorders: hypercalciuria Skin and subcutaneous tissue disorders: application site edema, application site pain, contact dermatitis (including allergic contact dermatitis), depigmentation, hypopigmentation, photosensitivity, rash (including erythematous, maculo-papular, and pustular), and urticaria.

DESCRIPTION Calcipotriene Ointment USP, 0.005% contains the compound calcipotriene, USP a synthetic vitamin D 3 derivative for topical dermatological use. Chemically, Calcipotriene, USP is 24-cyclopropyl-(1α,3β,5Z,7E,22E,24S)-9,10-Secochola-5,7,10(19),22-tetraene-1,3,24-trioI; with the empirical formula C 27 H 40 O 3 , a molecular weight of 412.62, and the following structural formula: Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene Ointment USP, 0.005% contains calcipotriene, USP 50 mcg/g in an ointment base of disodium phosphate dihydrate, edetate disodium, mineral oil, white petrolatum, propylene glycol, dl-alpha-tocopherol , steareth-2 and purified water. structure

OVERDOSAGE Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of calcipotriene ointment USP, 0.005%.

HOW SUPPLIED Calcipotriene Ointment USP, 0.005% is available in: 60 gram aluminum tube NDC (68462-310-65) 120 gram aluminum tube NDC (68462-310-66)