Osseka Special Precautions

Patient with hypercalcaemia: There is a close correlation between treatment with calcitriol and the development of hypercalcaemia.
All other vitamin D compounds and their derivatives, including proprietary compounds or foodstuffs which may be "fortified" with vitamin D, should be withheld during treatment with OSSEKA.
An abrupt increase in calcium intake as a result of changes in diet (e.g. increased consumption of dairy products) or uncontrolled intake of calcium preparations may trigger hypercalcaemia. Patients and their families should be advised that strict adherence to the prescribed diet is mandatory and they should be instructed on how to recognise the symptoms of hypercalcaemia.
As soon as the serum calcium levels rise to 1 mg/100 ml (250 μmol/l) above normal (9-11 mg/100 ml or 2250-2750 μmol/l), or serum creatinine rises to >120 μmol/L, treatment with calcitriol should be stopped immediately until normocalcaemia ensues (see Dosage & Administration).
Immobilised patients, e.g. those who have undergone surgery, are particularly exposed to the risk of hypercalcaemia.
Patient with renal failure: Calcitriol increases inorganic phosphate levels in serum. While this is desirable in patients with hypophosphataemia, caution is called for in patients with renal failure because of the danger of ectopic calcification. In such cases, the plasma phosphate level should be maintained at the normal level (2-5 mg/100 ml or 0.65-1.62 mmol/l) by the oral administration of appropriate phosphate-binding agents and low phosphate diet.
The serum calcium times phosphate (Ca x P) product should not be allowed to exceed 70 mg²/dl².
Patient with vitamin D-resistant rickets: Patients with vitamin D-resistant rickets (familial hypophosphataemia) who are being treated with calcitriol must continue their oral phosphate therapy. However, possible stimulation of intestinal absorption of phosphate by calcitriol should be taken into account since this effect may modify the need for phosphate supplementation.
Patients who switched from other derivatives of vitamin D: Since calcitriol is the most effective vitamin D metabolite available, no other vitamin D preparation should be prescribed during treatment with, thereby ensuring that the development of hypervitaminosis D is avoided.
If the patient is switched from a long acting vitamin D preparation (e.g. ergocalciferol (vitamin D2) or colecalciferol) to calcitriol, it may take several months for the ergocalciferol level in the blood to return to the baseline value, thereby increasing the risk of hypercalcaemia (see Overdosage).
Patients with normal renal function who are taking calcitriol should avoid dehydration. Adequate fluid intake should be maintained.
In patients with normal renal function, chronic hypercalcaemia may be associated with an increase in serum creatinine.
Effects on ability to drive and use machine: On the basis of the pharmacodynamic profile of reported adverse events, this product is presumed to be safe or unlikely to adversely affect such activities.