Calcipotriene cream, 0.005%, is indicated for the treatment of plaque psoriasis in adults. The safety and effectiveness of topical calcipotriene cream in dermatoses other than psoriasis have not been established.
Important Safety Information
- Calcipotriene cream 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 cream should not be used on the face.
- Use of calcipotriene cream may cause transient irritation of both lesions and surrounding uninvolved skin. If irritation develops, calcipotriene cream should be discontinued.
- Safety and effectiveness of calcipotriene cream 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.
- The most frequent adverse reactions reported for calcipotriene cream were burning, itching and skin irritation, which occurred in approximately 10-15% of patients. . Other experiences included erythema, dry skin, peeling, rash, dermatitis, worsening of psoriasis, skin atrophy, hyperpigmentation, hypercalcemia, and folliculitis.
- Once daily dosing has not been shown to be superior in safety to twice daily dosing.
For additional safety and other information, including Patient Information, please see Full Prescribing Information. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.