Dipsotrex Special Precautions

General: Use of Calcipotriol Ointment may cause irritation of lesions and surrounding uninvolved skin. If irritation develops, Calcipotriol Ointment should be discontinued. For external use only. Always wash hands thoroughly after use. Transient, rapidly reversible elevation of serum calcium has occurred with use of Calcipotriol Ointment. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.
Information for Patients: Patients using Calcipotriol Ointment should receive the following information and instructions: 1. 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.
2. This medication should not be used for any disorder other than that for which it was prescribed.
3. Patients should report to their physician any signs of local adverse reactions.
4. Patients that apply Calcipotriol Ointment to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).
For topical dermatological use only.
Not for Ophthalmic, Oral or Intravaginal Use.
Use in Children: Safety and effectiveness of Calcipotriol Ointment 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.
Use in Elderly: Of the total number of patients in clinical studies of Calcipotriol 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).