Medical Professional Home Page About Rocaltrol Important Safety Information Dosing and Administration Physician and Patient Checklist Representative Guidelines to Consider Prescribing Information
 
Physician/Patient Checklist
What to tell your patient to tell you while on therapy
•  If they become pregnant or are considering nursing while taking calcitriol, they should not breastfeed while taking calcitriol.
•  If they experience the following signs and symptoms of vitamin D toxicity: weakness, headache, sleepiness, nausea, vomiting, dry mouth, constipation, muscle or bone pain, metallic taste, lack of appetite or stomach ache, weight loss, change in urine, eye pain or sensitivity, abnormal sensations, or dizziness.
•  If there is any change in their prescription medicines, nonprescription medications, vitamins, nutritional supplements, and herbal products that they are taking, especially antacids; calcium supplements; cholestyramine; colestipol; digoxin; diuretics; ketoconazole; lanthanum; laxatives; oral steroids such as dexamethasone, methylprednisolone, and prednisone; other forms of vitamin D; phenobarbital; phenytoin; and sevelamer.
•  If they are taking ergocalciferol or have stopped taking it in the past few months.
References:
1. Rocaltrol [package insert]. Parsippany, NJ: Validus Pharmaceuticals; 2009.
 
Important Safety Information for Rocaltrol® (calcitriol) Capsules and Oral solution
Rocaltrol should not be given to patients with hypercalcemia or evidence of vitamin D toxicity. If hypercalcemia develops in a patient receiving Rocaltrol, treatment should be immediately discontinued. In treating chronic hypocalcemia and resultant metabolic bone disease in patients undergoing chronic dialysis, the optimal dose must be carefully determined for each patient. During the titration period of treatment with Rocaltrol, serum calcium levels should be checked at least twice daily. Reassessment and correction of dosage may be necessary.

Since Rocaltrol is believed to be the active hormone which exerts vitamin D activity in the body, adverse effects are, in general, similar to those encountered with excessive vitamin D intake, ie, hypercalcemia syndrome or calcium intoxication (depending on the severity and duration of hypercalcemia). Normalization of elevated serum calcium occurs within a few days of treatment withdrawal (ie, faster than in treatment with vitamin D3 preparations). Chronic hypercalcemia may lead to generalized calcification, nephrocalcinosis and other soft tissue calcification. The serum calcium times phosphate (Ca X P) product should not exceed 70 mg2/dL2. Overdose may require immediate medical attention.

Use with caution in patients receiving digitalis, as this may cause cardiac arrhythmias.

The information on this site is intended for reference only. It should not be used for prescribing or dispensing products; consult the attached full prescribing information.