DOVONEX- calcipotriene ointment
Bristol-Myers Squibb Company
FOR TOPICAL DERMATOLOGIC USE ONLY.
Not for Ophthalmic, Oral or Intravaginal Use.
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.
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.
Patients using Dovonex should receive the following information and instructions:
This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the face or eyes. As with any topical medication, patients should wash hands after application.
This medication should not be used for any disorder other than that for which it was prescribed.
Patients should report to their physician any signs of local adverse reactions.
Patients that apply Dovonex to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).
Nursing Mothers
It is not known whether calcipotriene is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Dovonex (calcipotriene ointment), 0.005% is administered to a nursing woman.
Pediatric Use
Safety and effectiveness of Dovonex 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.
Geriatric Use
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).
OVERDOSAGE
Topically applied Dovonex can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of Dovonex ointment.
DOSAGE AND ADMINISTRATION
Apply a thin layer of Dovonex ointment once or twice daily and rub in gently and completely.
HOW SUPPLIED
Dovonex� (calcipotriene ointment), 0.005% is available in:
60 gram aluminum tubes (NDC 0072-2540-06).
120 gram aluminum tubes (NDC 0072-2540-12).
STORAGE
Store at controlled room temperature 15� C-25� C (59� F-77� F). Do not freeze.
