ROCALTROL INDICATION:
Rocaltrol is indicated for the correction of the abnormalities of calcium and phosphate metabolism in patients with renal osteodystrophy. Rocaltrol is also indicated for the treatment of established post-menopausal osteoporosis. The dose of Rocaltrol should be carefully adjusted for each patient according to the biological response so as to avoid hypercalcaemia.
ROCALTROL CONTRA-INDICATIONS:
Rocaltrol should not be given to patients with hypercalcaemia or evidence of metastatic calcification. The use of Rocaltrol in patients with known hypersensitivity to calcitriol (or drugs of the same class) and any of the constituent excipients is contra-indicated. Rocaltrol is contra-indicated if there is evidence of vitamin D toxicity.
ROCALTROL DOSAGE:
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. Oral intermittent (pulse) therapy with Rocaltrol two or three times weekly has been shown to be effective in patients with osteodystrophy refractory to continuous therapy. Adults: Renal Osteodystrophy- The initial daily dose is 0.25mcg of Rocaltrol. In patients with normal or only slightly reduced calcium levels, doses of 0.25mcg every other day are sufficient. If no satisfactory response in the biochemical parameters and clinical manifestations of the disease is observed within 2 - 4 weeks, the dosage may be increased by 0.25mcg daily 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 1mg/100ml (250µmol/l) above normal (9 to 11mg/100ml or 2250 - 2750µmol/l), or serum creatinine rises to> 120µmol/l, treatment with Rocaltrol should be stopped immediately until normocalcaemia ensues. Most patients respond to between 0.5mcg and 1.0mcg daily. Higher doses may be necessary if barbiturates or anticonvulsant drugs are administered simultaneously. Post-menopausal Osteoporosis- The recommended dose of Rocaltrol is 0.25mcg twice daily. Serum calcium and creatinine levels should be determined at 4 weeks, 3 and 6 months and at 6 monthly intervals thereafter. Elderly- Clinical experience with Rocaltrol in elderly patients indicates that the dosage recommended for use in younger adults may be given without apparent ill-consequence. Children- Dosage in children has not been established. Rocaltrol capsules are for oral administration only.

Rocaltrol Side Effects:

ROCALTROL SIDE EFFECT PROFILE:
The number of adverse effects reported from clinical use of Rocaltrol over a period of 15 years in all indications is very low with each individual effect, including hypercalcaemia, occurring rarely. Hypercalcaemia and hypercalcuria are the major side effects of Rocaltrol and indicate excessive dosage. Patients with tertiary hyperparathyroidism, renal failure, or on regular haemodialysis are particularly prone to develop hypercalcaemia. The clinical features of hypercalcaemia include anorexia, constipation, nausea, vomiting, headache, weakness, apathy and somnolence. More severe manifestations may include thirst, dehydration, polyuria, nocturia, abdominal pain, paralytic ileus and cardiac arrhythmias. Rarely, overt psychosis and metastatic calcification may occur. The relatively short biological half-life of Rocaltrol permits rapid elimination of the compound when treatment is stopped and hypercalcaemia will recede within 2 - 7 days. This rate of reversal of biological effects is more rapid than when other vitamin D derivatives are used. In patients with normal renal function, chronic hypercalcaemia may be associated with an increase in serum creatinine. Mild, non-progressive and reversible elevations in levels of liver enzymes (SGOT, SGPT) have been noted in a few patients treated with Rocaltrol, but no pathological changes in the liver have been reported. Hypersensitivity reactions may occur in susceptible individuals.