Safety and effectiveness of calcipotriene in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic adverse effects when they are treated with topical medication.
Of the total number of patients in clinical studies of calcipotriene ointment, approximately 12% were 65 or older, while approximately 4% were 75 and over. The results of an analysis of severity of skin-related adverse events showed a statistically significant difference for subjects over 65 years (more severe) compared to those under 65 years (less severe).
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 calcipotriene ointment.
Apply a thin layer of calcipotriene ointment once or twice daily and rub in gently and completely.
Calcipotriene ointment, 0.005% is available in:
60 gram aluminum tube NDC (51672-4154-3)
120 gram aluminum tube NDC (51672-4154-4)
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
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Calcipotriene Ointment 0.005%
FOR TOPICAL DERMATOLOGIC USE ONLY. NOT FOR OPHTHALMIC, ORAL OR INTRAVAGINAL USE.
Keep this and all medications out of the reach of children.
| CALCIPOTRIENE |
|Labeler — Taro Pharmaceuticals U.S.A., Inc. (145186370)|
|Glenmark Generics Ltd.||677318665||MANUFACTURE (51672-4154)|
Revised: 12/2019 Taro Pharmaceuticals U.S.A., Inc.
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