CALCITRIOL

The dose of Calcitriol should be carefully adjusted for each patient according to the biological response so as to avoid hypercalcaemia. The effectiveness of treatment depends in part on an adequate daily intake of calcium, which should be augmented by dietary changes or supplements if necessary.

The capsules should be swallowed with a little water. 25 mcg of Calcitriol. 25 mcg every other day are sufficient. 25 mcg at 2 - 4 week intervals. During this period, serum calcium levels should be determined at least twice weekly. Should the serum calcium levels rise to 1 mg/100ml (250 μmol/l) above normal (9 to 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.

0 mcg daily. 5 for details of dose adjustments related to drug interactions. 1 mcg/kg/week split into two or three equal doses given at the end of the dialysis has been shown to be effective in patients with osteodystrophy refractory to continuous therapy.

A maximum total cumulative dosage of 12 mcg per week should not be exceeded. 25 mcg twice daily. Serum calcium and creatinine levels should be determined at 1, 3 and 6 months and at 6 monthly intervals thereafter. Elderly Clinical experience with Calcitriol in elderly patients indicates that the dosage recommended for use in younger adults may be given without apparent ill- consequence.

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

Method of administration Calcitriol capsules are for oral administration only.

The adverse reactions listed below reflect the experience from investigational studies of Calcitriol, and the post-marketing experience. The most commonly reported adverse reaction was hypercalcaemia. The ADRs listed in Table 1 are presented by system organ class and frequency categories, defined using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. e. 4). Occasional acute symptoms include decreased appetite, headache, nausea, vomiting, abdominal pain or abdominal pain upper and constipation.

e. much faster than in treatment with vitamin D3 preparations. Chronic effects may include muscular weakness, weight decreased, sensory disturbances, pyrexia, thirst, polydipsia, polyuria, dehydration, apathy, growth retardation and urinary tract infections.

9 mmol/l, calcinosis may occur; this can be seen radiographically. Hypersensitivity reactions including rash, erythema, pruritus and urticaria may occur in susceptible individuals. Laboratory Abnormalities In patients with normal renal function, chronic hypercalcaemia may be associated with a blood creatinine increase.

001 % or less. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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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 Calcitriol.

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.

2). g. those who have undergone surgery, are particularly exposed to the risk of hypercalcaemia. 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.

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. 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. Since calcitriol is the most effective vitamin D metabolite available, no other vitamin D preparation should be prescribed during treatment with Calcitriol, thereby ensuring that the development of hypervitaminosis D is avoided.

g. 9). 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.

1 • in all diseases associated with hypercalcaemia • in patients with evidence of metastatic calcification • if there is evidence of vitamin D toxicity.