Calcipotriene
Generic: CALCIPOTRIENE
Basic Information
Manufacturer
Glenmark Pharmaceuticals Inc., USA
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
1bc020e0-b5ae-4cda-aa5b-87fa0452a6bc
Indications & Usage
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.
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.
Adverse Reactions
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.
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.