Product Overview
Generic name: Alfacalcidol soft capsule
Chinese Pinyin: AFaGuHuaChunRuanJiaoNang
English name: Alfacalcidol Soft Capsules
Product name: Alfadi Three
Ingredients: The main ingredient of this product is alfacalcidol.
Properties: This product is a reddish brown (specification 0.25μg) or ivory color (specification 1μg) oval opaque soft capsule. The former is printed with "0.25" and the latter is printed with "1.0". The content is a yellow oily liquid .
Indications: 1. Rickets and rickets.
2. Renal bone disease.
3. Osteoporosis.
4. Hypoparathyroidism.
5. Rickets and osteomalacia caused by nutrition and malabsorption.
6. False calcium deficiency (D-dependent) rickets and osteomalacia.
Specification: 0.25μg*10 grains/plate, 2 plates/box
Usage and dosage: Oral.
⑴ Osteoporosis: the first dose is 0.5μg/day
⑵Other indications: First dose: 1μg/day Elderly patients: 0.5μg/day Children with a body weight of more than 20kg without renal bone disease: 1μg/day. In order to prevent the occurrence of hypercalcemia, the dosage of alfacalcidol should be adjusted according to serialized indicators. The blood calcium level must be measured every week at the beginning of the medication. The dose can be gradually increased in increments of 0.25-0.5μg/day, and the dose for most adult patients can reach 1-3μg/day. When the dose is stable, blood calcium is measured every 2-4 weeks. For patients with osteomalacia, the dosage of alfacalcidol cannot be increased because the blood calcium level has not risen rapidly. Other efficacy indicators, such as plasma alkaline phosphatase levels, can be used as more useful indicators for dose adjustment. Or follow the doctor's advice.
Adverse reactions: In addition to causing hypercalcemia and hyperphosphate in patients with kidney injury, there are no reports of other adverse reactions (for patients undergoing hypercalcemia dialysis, the possibility of calcium influx in the dialysate should be considered) . However, patients who have been taking large doses for a long time or suffering from kidney injury may have symptoms of hypercalcemia, such as nausea, dizziness, rash, constipation, anorexia, vomiting, abdominal pain, etc., and they can return to normal after stopping the drug.
Contraindications: (1) It is contraindicated in hypercalcemia, hyperphosphatemia (except those with hypoparathyroidism), and hypermagnesemia.
⑵Have symptoms of vitamin D poisoning. Patients who are allergic to any of the ingredients in this product or are known to be allergic to vitamin D and the like should not take alfacalcidol.
Note: Alfacalcidol can increase intestinal calcium and phosphorus absorption, so serum calcium and phosphorus levels should be monitored. Especially for patients with renal insufficiency. During the treatment with alfacalcidol, routine tests of calcium levels in plasma and urine (collected 24 hours) should be performed at least every three months. If high blood calcium or high urine calcium occurs during the administration, the drug should be stopped quickly until the blood calcium level returns to normal (it takes about one week), and then the dose can be halved as the previous dose. When the biochemical indicators of bone healing (such as plasma When the alkaline phosphatase level tends to normal), if the dosage of Alfadi III is not appropriately reduced, hypercalcemia will occur instinctively. Once hypercalcemia occurs, calcium supplementation should be stopped immediately.
Drug interactions: Patients with hypercalcemia taking digitalis preparations may accelerate arrhythmia. Therefore, the patient's condition must be closely monitored when digitalis preparations and alfacalcidol are used at the same time.
Patients taking barbiturates or other enzyme-induced anticonvulsants need a larger dose of alfacalcidol to produce therapeutic effects. Taking mineral oil (long-term), cholestyramine, sucralfate and aluminum antacid preparations at the same time may reduce the absorption of alfacalcidol.
Concurrent administration of magnesium-containing antacids or laxatives and alfacalcidol may lead to hypermagnesemia, so it should be used with caution in patients with chronic renal dialysis.
When alfacalcidol is taken together with calcium-containing preparations and thiazide diuretics, it may increase the risk of hypercalcemia.
As alfacalcidol is a potent vitamin D derivative, the simultaneous use of pharmacological doses of vitamin D and its analogues should be avoided to avoid possible additive effects and hypercalcemia.
Pharmacology and Toxicology: Alfacalcidol is rapidly converted into 1,25-dihydroxyvitamin D3 in the liver, and later... [Detail] Alfacalcidol is rapidly converted into 1,25-dihydroxyvitamin D3 in the liver, and then It is a metabolite of vitamin D3, which regulates calcium and phosphate metabolism. Due to the rapid conversion process, the clinical effect of alfacalcidol is basically the same as that of 1,25-dihydroxyvitamin D3. Its main function is to increase the intestinal absorption of calcium and phosphate by increasing the level of 1,25-dihydroxyvitamin D3 in the blood circulation in the body, promote bone mineralization, reduce plasma parathyroid hormone levels, and reduce bone calcium dissolution. Relieve bone and muscle pain and improve osteoporosis caused by intestinal calcium absorption disorder caused by menopause, aging and endocrine changes.
Pharmacokinetics: The peak plasma concentration (Cmax) of this product after oral administration of 1μg is 61.6±13.6pg/ml, and the average peak time is 8 hours (6-16 hours).
Drugs for pregnant women and breastfeeding women: There is not enough evidence on the safety of taking alfacalcidol during pregnancy. Although animal tests have shown that it is harmless, it is the same as other drugs. For other alternatives, you can use alfacalcidol. The safety of medication during lactation has not yet been finalized, but when taking alfacalcidol, the content of 1.25-dihydroxyvitamin D in breast milk may increase, as this will affect the baby’s calcium metabolism, so breastfeeding should consider stopping medicine.
Children's medication: see usage and dosage, or follow doctor's advice.
Medication for elderly patients: Refer to usage and dosage, precautions, etc., or follow the doctor's advice.
Drug overdose: manifestations: clinical manifestations of high blood calcium as myopathy, fatigue, weakness, dizziness, drowsiness, headache, nausea, dry mouth, constipation, diarrhea, heartburn, vomiting, abdominal pain or other gastrointestinal discomfort, muscle pain, bone pain , Joint pain, itching or heart palpitations. Treatment: If you have hypercalcemia, stop taking alfacalcidol. Severe hypercalcemia may require supportive measures and treatment with diuretics and infusions, or corticosteroids. Early treatment of acute overdose uses gastric lavage and/or mineral oil to reduce calcium absorption and promote fecal excretion.
Storage: Store in an airtight, shaded, cool place (not exceeding 20°C).
Packing: Double aluminum blister pack 0.25μg:
10 tablets/plate, 2 plates/box
Validity period: 36 months
Approval number: National Medicine Standard J20171090
Company Name: Kunming Baker Norton Pharmaceutical Co., Ltd.
