ZODORAY Capsule Ref.[50532] Active ingredients: Alfacalcidol

Posology

Initial dose for all indications

Adults: 1 µg daily

Children 20 kg body weight and above: 1 µg daily

Children less than 20 kg body weight: 0,05 µg/kg daily

Elderly: 0,5 μg daily

It is important to adjust dosage thereafter according to the biochemical responses and to avoid hypercalcaemia. Indices of response include levels of plasma calcium, alkaline phosphatase, parathyroid hormone, urinary calcium excretion as well as radiographic and histological investigations. Correct plasma levels should initially be measured at weekly intervals. The daily dose of Alfacalcidol may be increased by increments of 0,25-0,5 μg. When the dose is established, plasma levels of calcium, phosphorous and creatinine should be taken every 2-4 weeks.

Patients with marked bone disease may tolerate a higher dose without developing hypercalcaemia. However, failure of the plasma calcium to rise promptly in osteomalacic patients does not necessarily mean that a higher dose is required, since calcium from increased intestinal calcium absorption may be incorporated into demineralised bone. Most patients respond to doses between 1 to 3 µg daily.

The dose requirements generally decrease in bone disorders at a time when there is biochemical or radiographic evidence of bone healing and in hypoparathyroid patients after normal plasma calcium levels have been attained. Maintenance doses are generally in the range of 0,25 to 1 µg daily.

Paediatric population

For neonatal hypocalcaemia the normal starting dose of 1α-OHD₃ is 0,05 to 0,1 µg/kg/day. Adjustment of the dose thereafter is by careful titration. Whilst ionised serum calcium levels may provide a guide to response; measurement of plasma alkaline phosphatase activity may be more useful. Levels of plasma alkaline phosphatase may be markedly raised in the pre-term low birthweight infant. Whilst level of 5 times the normal adult laboratory value may be usual in this group, alkaline phosphatase levels above 7,5 times the adult range indicate active disease.

The initial signs and symptoms of vitamin D intoxication associated with hypercalcaemia include weakness, fatigue, somnolence, headache, anorexia, nausea, vomiting, diarrhoea, and pruritus. If hypercalcaemia is allowed to persist, the following may also develop: conjunctivitis, a shortened Q-T interval and cardiac dysrhythmias, manifestations of impaired renal function consisting of polyuria, polydipsia, nocturia, hyposthenuria, dehydration and mild proteinuria. Agitation, apprehension, pain in the extremities, paralytic ileus, abdominal pain and, rarely, overt psychosis. Some mild elevations in AST and ALT have been reported in a small percentage of patients treated with ZODORAY.

Treatment of hypercalcaemia and overdosage in patients on haemodialysis: General treatment of hypercalcaemia (greater than 0,25 mmol/l above the upper limit of the normal range) consists of immediate discontinuation of ZODORAY therapy, institution of a low calcium diet and withdrawal of calcium supplements.

General supportive measures: Keep the patient well hydrated by IV infusion of 0.9% sodium chloride (forced diuresis), measure electrolytes, calcium and renal function indices; assess electrocardiographic abnormalities, especially in patients on digoxin.

Specific treatment: Glucocorticosteroids, loop diuretics, bisphosphonates, calcitonin and eventually haemodialysis with low calcium content dialysis fluid.

Serum calcium levels should be determined daily until normocalcaemia ensues.

Hypercalcaemia frequently resolves in two to seven days. When serum calcium levels have returned to within normal limits, therapy may be reinstituted at a dose of 0,25 µg/day less than prior therapy. Serum calcium levels should be obtained at least twice weekly after all dosage changes and subsequent dosage titration. Persistent or markedly elevated serum calcium levels may be corrected by dialysis against a calcium-free dialysate.

2 years. Store at or below 25°C.

This medicine does not require any special storage conditions.

White, opaque HDPE container with white opaque HDPE screw closure and induction sealing.

Pack sizes of 30’s, 50’s and 100’s.

Not all pack sizes may be marketed.

No special requirements.