Please read the instructions carefully and use them under the guidance of a physician.
Common Name : Alfacalculated Softgel
Chinese Pinyin : AFaGuHuaChunRuanJiaoNang
English name : Alfacalcidol Soft Capsules
Product name : Alfadi III
Ingredients : The main ingredient of this product is Alfacalcitol.
Properties: This product is reddish brown (size 0.25μg) or ivory (size 1μg) oval opaque soft capsule, the former of the capsule shell is printed with "0.25", the latter is printed with the word "1.0", the content is yellow oily liquid .
Indications: 1. Rickets and rickets.
2. Renal bone disease.
5. Rickets and osteomalacia caused by nutrition and malabsorption.
6. False calcium deficiency (D-dependent) of rickets and osteomalacia.
Specifications : 0.25μg*10 tablets/plate, 2 plates/box
Dosage : Oral.
(1) Osteoporosis: first dose 0.5μg / day
(2) Other indications: first dose: 1 μg / day Elderly patients: 0.5 μg / day body weight 20 kg or more children without renal osteosis: 1 μg / day. In order to prevent the occurrence of hypercalcemia, the dose of Alfacalcidol should be adjusted according to the serialization index. Blood calcium levels must be measured weekly at the beginning of the drug. The dose can be gradually increased in increments of 0.25-0.5 μg/day, and the dose of most adult patients can reach 1-3 μg/day. When the dose is stable, blood calcium is measured every 2-4 weeks. For patients with osteomalacia, the amount of Alfacalcidol should not be increased because its blood calcium level does not rise rapidly. Other therapeutic indicators, such as plasma alkaline phosphatase levels, can be used as a more useful indicator for adjusting the dose. Or follow the doctor's advice.
Adverse reactions: In addition to causing hypercalcemia and hyperphosphatemia in patients with renal impairment, there are no reports of other adverse reactions (for patients undergoing hypercalcemia dialysis, the possibility of calcium influx in dialysate should be considered) . However, patients with long-term high-dose or kidney damage may have signs of hypercalcemia such as nausea, dizziness, rash, constipation, anorexia, vomiting, and abdominal pain, and return to normal after stopping the drug.
Contraindications: (1) Banned from hypercalcemia, hyperphosphatemia (except for hypoparathyroidism), hypermagnesemia.
(2) has symptoms of vitamin D poisoning. Alphacalcitol cannot be taken on any of the ingredients in this product or in patients known to be allergic to vitamin D and its analogues.
Note: Alfacalcidol can increase intestinal calcium and phosphorus absorption, so serum and phosphorus levels should be monitored. Especially for patients with renal insufficiency. A routine test of plasma and urine (24-hour collection) calcium levels was performed at least every three months during the course of treatment with alfacalcidol. If high blood calcium or high urinary calcium occurs during taking, it should be stopped quickly until the blood calcium level returns to normal (about one week), then you can halve the dose by the second dose, when the bone healing biochemical indicators (such as plasma When the level of alkaline phosphatase is normal, if the dosage of Alfadi is not properly reduced, hypercalcemia will occur in the instinct. Once hypercalcemia occurs, calcium supplementation should be stopped immediately.
Drug Interactions: The use of digitalis preparations in patients with hypercalcemia may accelerate arrhythmia, so the digital display must be closely monitored when the digitalis preparation is applied simultaneously with alfacalcidol.
Patients taking barbiturates or other enzyme-induced anticonvulsants require a larger dose of Alfacalcidol to produce a therapeutic effect. Simultaneous use of mineral oil (long-term), cholestyramine, sucralfate and antacid formulations may reduce the absorption of alfacalcidol.
Magnesium-containing antacids or laxatives taken with alfacalcidol may cause hypermagnesemia and should be used with caution in patients with chronic kidney dialysis.
Alfacalcidol may increase the risk of hypercalcemia when taken simultaneously with calcium-containing preparations and thiazide diuretics.
Since 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: Alfacalcitol is rapidly converted into 1,25-dihydroxyvitamin D3 in the liver, after... [detailed] Alfacalcitol is rapidly converted to 1,25-dihydroxyvitamin D3 in the liver, after It is a metabolite of vitamin D3, which regulates the metabolism of calcium and phosphate. Since this transformation process is rapid, the clinical effect of Alfacalcidol is basically consistent with 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. Relieves bone and muscle pain and improves osteoporosis caused by intestinal calcium absorption disorders caused by menopause, aging and endocrine changes.
Pharmacokinetics: The peak plasma concentration (Cmax) after oral administration of 1 μg of this product was 61.6±13.6 pg/ml, and the peak time was 8 hours (6-16 hours).
Pregnancy and lactating women medication: There is not enough evidence for the safety of taking Alfacalcidol during pregnancy. Although animal tests show that it is harmless, like other drugs, only need to be used during pregnancy and no For other alternatives, alfacalcidol can be used. The safety of lactation medication has not been finalized, but the dose of 1.25-dihydroxyvitamin D in breast milk may increase when taking Alfacalcidol. Since this will affect the calcium metabolism of infants, it should be considered during lactation. medicine.
Pediatric Use: See usage and dosage, or as directed by your doctor.
Drugs for elderly patients: See usage and dosage, precautions, etc., or as directed by your doctor.
Overdose: Performance: Hypercalcemia clinical manifestations of 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 palpitations. Treatment: High blood calcium should 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 a closed, shading, cool place (not exceeding 20 ° C).
Packing : Double aluminum blister pack 0.25μg:
10 tablets / plate, 2 plates / box
Validity: 36 months
Approval number : Imported drug registration number: H20130448
National medicine standard word J20130162
Company Name : Kunming Baker Norton Pharmaceutical Co., Ltd.