Alfacalcidol Soft Capsules

After oral administration, this product is rapidly metabolized in the liver into 1alpha;, 25-(OH)2D3, which has an important effect on calcium, phosphorus metabolism and bone growth. Its pharmacological action is the same as that of vitamin D.

The main ingredient of this product is alfacalcidol. Chemical name: (5Z, 7E)-9,10-opened cholesteryl-5,7,10 (19)-triene-1α, 3β-diol

1. Rickets and osteomalacia. 2. Renal osteodystrophy. 3. Osteoporosis. 4. Hypoparathyroidism.

1. Osteoporosis: initial dose 0.5 μg/day. 2. Other indications: initial dose for adults: 1 μg/day, for elderly patients: 0.5 μg/day. Children weighing more than 20 kg without renal osteopathy: 1 μg/day. In order to prevent the occurrence of hypercalcemia, the dose of alfacalcidol should be adjusted according to serialized indicators. Blood calcium levels must be measured weekly in the initial stage of medication, and the dose can be gradually increased by 0.25-0.5 μg/day. The dose for most adult patients can reach 1-3 μg/day. When the dose is stable, blood calcium should be measured every 2-4 weeks. For patients with osteomalacia, the dosage of alfacalcidol should not be increased just because their blood calcium levels do not rise rapidly. Other efficacy indicators, such as plasma alkaline phosphatase levels, can be used as more useful indicators for adjusting the dose.

Except for causing hypercalcemia and hyperphosphatemia in patients with renal damage, no other adverse reactions have been reported (the possibility of calcium influx in the dialysate should be considered for patients with hypercalcemia undergoing dialysis). However, patients who take large doses for a long time or suffer from renal damage may experience nausea, dizziness, rash, constipation, anorexia, vomiting, abdominal pain and other signs of hypercalcemia, which will return to normal after stopping the drug.

1. It is contraindicated in patients with hypercalcemia, hyperphosphatemia (except those with hypoparathyroidism), and hypermagnesemia. 2. Patients with symptoms of vitamin D poisoning. Patients who are allergic to any ingredient in this product or are known to be allergic to vitamin D and its analogs should not take alfacalcidol.

Patients with hypercalcemia may experience accelerated arrhythmias when taking digitalis preparations, so patients must be closely monitored when digitalis preparations are used simultaneously with alfacalcidol. Patients taking barbiturates or other enzyme-inducing anticonvulsants may require larger doses of alfacalcidol to produce therapeutic effects. Concomitant use of mineral oil (long-term), cholestyramine, sucralfate, and antacid aluminum preparations may reduce the absorption of alfacalcidol. Concomitant use of magnesium-containing antacids or laxatives with alfacalcidol may lead to hypermagnesemia, so it should be used with caution in patients on chronic renal dialysis. Concomitant use of alfacalcidol with calcium-containing preparations and thiazide diuretics may increase the risk of hypercalcemia. Since alfacalcidol is a potent vitamin D derivative, simultaneous use of pharmacological doses of vitamin D and its analogs should be avoided to avoid possible additive effects and hypercalcemia.

[02] Cool storage area for medicines (below 20°C)

0.25 μg

36 months