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The safety and efficacy of calcitriol capsules in children have not been sufficiently investigated to enable dosing recommendationsLimited data are available for the use of calcitriol capsules in paediatric patients.

Excessive dosage of Rocaltrolcalcitriolinduces hypercalcemia and in some instances hypercalciuriathereforeearly in treatment during dosage adjustmentserum calcium should be determined twice weeklyIn dialysis patientsa fall in serum alkaline phosphatase levels usually antedates the appearance of hypercalcemia and may be an indication of impending hypercalcemiaAn abrupt increase in calcium intake as a result of changes in dietegincreased consumption of dairy productsor uncontrolled intake of calcium preparations may trigger hypercalcemia.

Oral doses of Rocaltrolcalcitriolranging from 10 to 55 ng/kg/day have been shown to improve calcium homeostasis and bone disease in pediatric patients with chronic renal failure for whom hemodialysis is not yet requiredpredialysisLong-term calcitriol therapy is well tolerated by pediatric patientsThe most common safety issues are mildtransient episodes of hypercalcemiahyperphosphatemiaand increases in the serum calcium times phosphateCa x Pproduct which are managed effectively by dosage adjustment or temporary discontinuation of the vitamin D derivative.

For dialysis patientsserum calciumphosphorusmagnesiumand alkaline phosphatase should be determined periodicallyFor hypoparathyroid patientsserum calciumphosphorusand 24-hour urinary calcium should be determined periodicallyFor predialysis patientsserum calciumphosphorusalkaline phosphatasecreatinineand intact PTHiPTHshould be determined initiallyThereafterserum calciumphosphorusalkaline phosphataseand creatine should be determined monthly for a 6-month period and then determined periodicallyIntact PTHiPTHshould be determined periodically every 3 to 4 months at the time of visitsDuring the titration period of treatment with Rocaltrolcalcitriolserum calcium levels should be checked at least twice weeklysee DOSAGE AND ADMINISTRATION

Overdosage of any form of vitamin D is dangeroussee OVERDOSAGEProgressive hypercalcemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attentionChronic hypercalcemia can lead to generalized vascular calcificationnephrocalcinosis and other soft-tissue calcificationThe serum calcium times phosphateCa x Pproduct should not be allowed to exceed 70 mg 2dL 2Radiographic evaluation of suspect anatomical regions may be useful in the early detection of this condition.

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