calcipotriene
Generic: CALCIPOTRIENE
Basic Information
Manufacturer
Prasco Laboratories
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
fe7cd92a-f066-4c4a-80c8-e3f929ad4181
Indications & Usage
INDICATIONS AND 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.
The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.
Warnings
WARNINGS Contact dermatitis, including allergic contact dermatitis, has been observed with the use of Calcipotriene Ointment.
Adverse Reactions
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.
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.