Alfacalcidol Capsules

Alfacalcidol is rapidly converted into 1,25-dihydroxyvitamin D3 in the liver. The latter is a metabolite of vitamin D3 and plays a role in regulating calcium and phosphate metabolism. Since this conversion process is very rapid, the clinical effects of alfacalcidol are basically the same as those of 1,25-dihydroxyvitamin D3. Its main function is to increase the level of 1,25-dihydroxyvitamin D3 in the blood circulation, thereby increasing the intestinal absorption of calcium and phosphate, promoting bone mineralization, reducing plasma parathyroid hormone levels, and reducing bone calcium dissolution.

The main ingredient of this product is alfacalcidol, and its chemical name is (5Z, 7E)-9,10-opened cholesteryl-5,7,10(19)-triene-1alpha;,3beta;-diol.

This product is an oval transparent soft capsule

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

Oral. The first dose for osteoporosis patients is: 0.5ug/day; the first dose for all other indications is: 1ug/day for adults; 0.5ug/day for elderly patients; 1ug/day for children weighing more than 20kg without renal osteopathy. In order to prevent the occurrence of hypercalcemia, the dose of alfacalcidol should be adjusted according to biochemical indicators. Blood calcium levels must be measured weekly in the initial stage of medication, and the dose can be gradually increased by 0.25-0.5ug/day. The dose for most adult patients can reach 1-3ug/day. When the dose is stable, measure blood calcium 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 the drug in 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.

It is contraindicated in patients with hypercalcemia, hyperphosphatemia (except those with hypoparathyroidism), and hypermagnesemia; 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.

Precautions for children: See the dosage and administration, or follow the doctor's advice. Precautions for pregnancy and lactation: 1. There is not enough evidence for the safety of taking alfacalcidol during pregnancy. Although animal experiments have shown that it is harmless, like other drugs, alfacalcidol can be used only when it is needed during pregnancy and there are no other alternatives. 2. The safety of medication during lactation has not been finally determined, but when taking alfacalcidol, the content of 1,25-dihydroxyvitamin D3 in breast milk may increase. Since this will affect the calcium metabolism of infants, the drug should be discontinued during lactation. Precautions for the elderly: See the dosage and administration, precautions, etc., or follow the doctor's advice.

Patients with hypercalcemia may experience accelerated arrhythmias when taking digitalis preparations, so patients must be closely monitored when digitalis preparations are used concomitantly 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 antacid preparations 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 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.

Sealed and stored in a cool place.

0.25 μg

Tentative 18 months

Kunming Baker NORTON Pharmaceutical Co., Ltd.

• Founded in:

  1992-07-30

• Address:

  7km west of Wuhua District, Kunming City, Yunnan Province

• Tax NO.:

  915300006226003939

• Registered Funds:

  $8,527,898

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