Product Description.:
Cream , white
White to off-white
Dovonex? (calcipotriene ointment), 0.005% contains the compound calcipotriene, a synthetic vitamin D3 derivative, for topical dermatological use.
Calcipotriene is a white or off-white crystalline substance. Dovonex? ointment contains calcipotriene 50 ?g/g in an ointment base of dibasic sodium phosphate, edetate disodium, mineral oil, petrolatum, propylene glycol, tocopherol, steareth-2 and water.
INDICATIONS
Dovonex? (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.
DOSAGE AND ADMINISTRATION
Apply a thin layer of Dovonex? ointment once or twice daily and rub in gently and completely.
SIDE EFFECTS
In controlled clinical trials, the most frequent adverse reactions reported for Dovonex? 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.
WARNINGS
No information provided.
PRECAUTIONS
General
Use of Dovonex? may cause irritation of lesions and surrounding uninvolved skin. If irritation develops, Dovonex? should be discontinued.
For external use only. Keep out of the reach of children. Always wash hands thoroughly after use.
Transient, rapidly reversible elevation of serum calcium has occurred with use of Dovonex?. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.
