orticosteroids.Parenteral drug products such as Calcijex should be inspected visually for particulate matter prior to administration. Although calcitriol itself is a colourless, crystalline compound, the sodium ascorbate added as an antioxidant in Calcijex is white or very faintly yellow, and can turn yellow as it combines with oxygen.Calcijex should be drawn up into a plastic 1ml tuberculin syringe and administered at a bolus dose intravenously at the end of dialysis. It may be administered through the catheter at the end of haemodialysis.
Child Dosage
Safety and efficacy of Calcijex in children have not be established.The use of Calcijex in paediatric patients aged between 9 and 18 years of age was investigated in a clinical trial in paediatric end stage renal disease patients on haemodialysis.
Contra Indications
Calcijex should not be given to patients with hypercalcaemia or evidence of vitamin D toxicity.This drug is contraindicated in patients with previous hypersensitivity to calcitriol or any of its excipients.
Special Precautions
General Excessive dosage of Calcijex induces hypercalcaemia, and in some instances hypercalciuria; therefore, early in treatment during dosage adjustment, serum calcium and phosphate should be determined at least twice weekly. Should hypercalcaemia develop, the drug should be discontinued immediately.Calcijex should be given cautiously to patients on digitalis, because hypercalcaemia in such patients may precipitate cardiac arrhythmias.Adynamic bone disease may develop if PTH levels are suppressed to abnormal levels. Monitoring of the development of adynamic bone disease can be performed using bone biopsies, or more simply via measurement of PTH levels. The use of bone biopsies to monitor the development of adynamic bone disease is appropriate if the biopsies are being performed primarily for other diagnostic reasons. Otherwise PTH levels may replace a bone biopsy for this purpose. It PTH levels fall below the recommended target range in patients treated with Calcijex, the Calcijex dose should be reduced or therapy discontinued. Discontinuation of Calcijex therapy may result in rebound effect, therefore, appropriate titration downward to a maintenance dose is recommended.Since calcitriol is the most potent metabolite of vitamin D available, vitamin D and its derivatives should be withheld during treatment.In patients undergoing dialysis who have high serum phosphate levels, appropriate serum phosphate binders should be used. Aluminium containing phosphate binders should not be used except in exceptional circumstances.Low calcium dialysis fluids may be helpful in patients who develop hypercalcaemia whilst taking calcium-based phosphate binders in combination with vitamin D analogues.Overdosage of any form of vitamin D is dangerous. Progressive hypercalcaemia due to overdosage of vitamin D and its metabolites may be so severe as to require emergency attention. Chronic hypercalcaemia can lead to generalised vascular calcification, nephrocalcinosis and other soft tissue calcification. The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 7 - 8. Radiographic eva luation of suspects anatomical regions may be useful in the early detection of this condition.Information for the PatientThe patient should be informed about adherence to instructions about diet and calcium supplementation and avoidance of the use of unapproved non-prescription drugs, including mag
