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.
Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of Calcitrene® (calcipotriene) ointment, 0.005%.
Apply a thin layer of Calcitrene® (calcipotriene) ointment, 0.005% once or twice daily and rub in gently and completely.
Calcitrene® (calcipotriene) ointment, 0.005% is available in:
60 gram aluminum tube NDC (51672-5278-3)
120 gram aluminum tube NDC (51672-5278-4)
Store at controlled room temperature 15°C-25°C (59°F-77°F). Do not freeze.
Glenmark Generics Ltd.
Colvale-Bardez, Goa 403 513, India
TaroPharma a division of Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
TaroPharma® and Calcitrene® are trademarks of Taro Pharmaceuticals U.S.A., Inc and/or its affiliates.
Calcipotriene Ointment 0.005%
FOR TOPICAL DERMATOLIGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
Keep this and all medications out of the reach of children.
| CALCITRENE |
|Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)|
|Glenmark Generics Ltd.||677318665||MANUFACTURE (51672-5278)|
Revised: 01/2019 Taro Pharmaceuticals U.S.A., Inc.
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