Alfacalcidol

Should be taken with food.

Hypercalcaemia, hyperphosphataemia, vitamin D toxicity, metastatic calcification.

Patient with pulmonary tissue calcification, granulomatous diseases (e.g. sarcoidosis), nephrolithiasis, hypermagnesaemia. Concomitant treatment with digitalis glycosides; barbiturates and other anticonvulsants. Renal impairment. Children and elderly. Pregnancy and lactation. Monitoring Parameters Monitor serum Ca and phosphate levels regularly, such as at least twice weekly, during treatment initiation and dose adjustments (particularly in children, patients with renal impairment, or taking high doses); PTH, alkaline phosphatase, and Ca x phosphate product as clinically indicated. Measurement frequency may be dependent on the presence and magnitude of abnormalities, and rate of disease progression.

Significant: Hypercalcaemia (when prolonged may cause generalised vascular and soft tissue calcification, and exacerbated nephrolithiasis, arteriosclerosis or cardiac valve sclerosis); over suppression of PTH, hypercalciuria, hyperphosphataemia, adynamic bone disease; transient or long-lasting decreased kidney function. Ear and labyrinth disorders: Vertigo. Gastrointestinal disorders: Nausea, vomiting, diarrhoea, abdominal pain and discomfort, constipation. General disorders and administration site conditions: Lassitude, asthenia, malaise, calcinosis. Investigations: Increased plasma and urinary concentrations of Ca and phosphate, weight loss. Metabolism and nutrition disorders: Anorexia, thirst. Musculoskeletal and connective tissue disorders: Myalgia. Nervous system disorders: Headache. Rarely, dizziness. Psychiatric disorders: Confusional state. Renal and urinary disorders: Polyuria, acute renal failure, nephrocalcinosis. Skin and subcutaneous tissue disorders: Rash (e.g. maculo-papular, erythematous, pustular), pruritus, sweating, urticaria.

Increased risk of hypercalcaemia with thiazide diuretics, Ca-containing or other vitamin D-containing preparations. May precipitate cardiac arrhythmias with digitalis glycosides. Intestinal absorption may be impaired by colestyramine, colestipol, sucralfate, Al-based antacids (high dose), and mineral oil (prolonged use). May increase serum levels of Al in aluminium hydroxide, sucralfate or other Al-containing preparations. May increase metabolism with anticonvulsants (e.g. phenytoin, phenobarbital, carbamazepine, primidone). May cause hypermagnesaemia with Mg-based antacids or laxatives in dialysis patients.

Agents Affecting Bone Metabolism

A11CC03 - alfacalcidol ; Belongs to the class of vitamin D and analogues. Used as dietary supplements.