Calcitriol Soft Capsules

1. Calcitriol is one of the most important active metabolites of vitamin D3. It is usually converted from its precursor 25-hydroxyvitamin D3 (25-HCC) in the kidneys. The normal physiological daily production is 0.5-1.0 mu; g, and its production increases slightly during the period of increased bone synthesis (such as growth or pregnancy). Calcitriol promotes intestinal absorption of calcium and regulates bone mineralization. The pharmacological effect of a single dose of calcitriol can last for about 3-5 days. 2. Calcitriol plays a key role in regulating calcium balance, including stimulating the activity of osteoblasts in bones, which provides a sufficient pharmacological basis for the treatment of osteoporosis. 3. For patients with renal osteodystrophy, oral administration of this product can restore the ability of the intestine to absorb calcium to normal, correct hypocalcemia, and excessive blood alkaline phosphatase and blood parathyroid hormone concentrations. This product can relieve bone and muscle pain and correct histological changes that occur in patients with osteitis fibrosa and other patients with insufficient mineralization. 4. In patients with vitamin D-dependent rickets, the level of calcitriol in the blood is reduced or absent. Due to insufficient production of calcitriol in the kidneys, this product can be considered as an alternative treatment. 5. In patients with vitamin D-resistant rickets and hypophosphatemia, the blood calcium level is reduced. This product can reduce the tubular clearance of phosphorus and, combined with the treatment of phosphorus preparations, restore bone growth. 6. Even at very high doses, there is no evidence that vitamin D has a teratogenic effect on humans.

Calcitriol.

1. Postmenopausal osteoporosis; 2. Chronic renal failure, especially renal osteodystrophy in patients receiving hemodialysis; 3. Postoperative hypoparathyroidism; 4. Idiopathic hypoparathyroidism; 5. Pseudohypoparathyroidism; 6. Vitamin D-dependent rickets; 7. Hypophosphatemic vitamin D-resistant rickets, etc.

1. The optimal daily dose of this product should be carefully formulated according to the blood calcium level of each patient. When starting treatment with this product, the lowest dose should be used as much as possible, and the dosage should not be increased without monitoring the blood calcium level. 2. After determining the optimal dose of this product, the blood calcium level should be checked once a month (or refer to the detailed instructions for individual indications below). 3. When collecting blood calcium samples, a tourniquet should not be used. If the blood calcium exceeds the normal range (9-11mg/100ml or 2250-2750μmol/l) 1mg/100ml (250μmol/l), or the blood creatinine is greater than 120μmol/l, the dose must be reduced or treatment must be completely stopped until the blood calcium returns to normal. 4. During the period of increased blood calcium, blood calcium and blood phosphorus levels must be measured daily. This product can be taken after blood calcium returns to normal, but the daily dose should be 0.25μg lower than the previous dose. The daily calcium intake should be estimated and adjusted as appropriate. 5. The prerequisite for the best efficacy of this product is sufficient but not excessive calcium intake (adults: about 800 mg per day). Calcium supplementation is necessary at the beginning of treatment. 6. Because of the improvement of calcium absorption by the gastrointestinal tract, some patients may need to maintain a lower calcium intake. Patients with a tendency to hypercalcemia may only need a small dose of calcium supplementation or no calcium supplementation at all. 7. The average total daily calcium intake (such as from food and medicine) is about 800 mg and should not exceed 1000 mg. Oral administration, the specific method is as follows: 1. Postmenopausal osteoporosis: The recommended dose is 0.25 μg each time, twice a day. After taking the medicine, monitor the blood calcium and blood creatinine concentrations in the 4th week, 3rd month, and 6th month, and monitor every six months thereafter. 2. Renal osteodystrophy (including dialysis patients): The daily dose in the initial stage is 0.25 μg. Patients with normal or slightly reduced blood calcium can take 0.25 μg every other day. If there is no significant improvement in biochemical indicators and condition within 2 to 4 weeks, the daily dose of this product will be increased by 0.25 μg every 2 to 4 weeks, and blood calcium should be measured at least twice a week during this period. The optimal dose for most patients is between 0.5 and 1.0 μg per day. 3. Hypoparathyroidism and rickets: The recommended starting dose is 0.25 μg per day, taken in the morning. If there is no significant improvement in biochemical indicators and condition, the dose will be increased every 2 to 4 weeks. During this period, blood calcium concentration should be measured at least twice a week. Poor absorption is occasionally seen in patients with hypoparathyroidism, so such patients need a larger dose. If the doctor decides to treat pregnant women with hypoparathyroidism with this product, the dose should be increased in the late pregnancy and reduced in the postpartum and lactation period. 4. Elderly patients: Elderly patients do not need special doses, but it is recommended to monitor blood calcium and blood creatinine concentrations. 5. Infants and children: The solution dosage form of this product is suitable for infants and children. As with adults, the optimal daily dose should be determined based on the measurement of blood calcium levels. For children under 6.2 years old, the recommended daily reference dose is 0.01-0.1 μg/kg body weight. The measuring tube included in the package can accurately measure the dose required for each patient. The dosage volume can be measured in milliliters or drops: 0.1 ml of solution is equivalent to 0.1 μg of active ingredient (calcitriol), or 1 drop of solution contains 0.02 μg of calcitriol. The solution can be put into a spoon and then mixed into the child's drink (such as orange juice, etc.). The bottle cap should be tightened after use. Within the validity period after opening the cap (6 weeks), the original screw cap can be replaced with the cap of the dropper.

1. Since calcitriol can produce the effects of vitamin D, adverse reactions that may occur are similar to those of vitamin D overdose, such as hypercalcemia syndrome or calcium poisoning (depending on the severity and duration of hypercalcemia). Occasional acute symptoms include loss of appetite, headache, vomiting and constipation. Chronic symptoms include malnutrition, sensory impairment, fever with thirst, polyuria, dehydration, emotional apathy, developmental arrest and urinary tract infection. 2. The clinical use of this product for all indications for up to 15 years has shown that the incidence of adverse reactions is very low, including hypercalcemia, with an incidence of 0.001% or less. 3. Patients with concurrent hypercalcemia and hyperphosphatemia (concentration greater than 6mg/100ml or 1.9mmol/l) may develop soft tissue calcification, which can be observed through radiological examinations. In patients with normal renal function, chronic hypercalcemia may be associated with increased blood creatinine. Since the biological half-life of calcitriol is short, its pharmacokinetic studies have shown that elevated blood calcium returns to normal range after stopping or reducing the dosage for a few days, a process that is much faster than vitamin D3. 4. Allergic reactions may occur in patients with sensitive constitutions.

This product is contraindicated in patients with diseases related to hypercalcemia, patients with known allergies to this product or similar drugs and any of their excipients; and patients with signs of vitamin D poisoning.

Precautions for children: See [Usage and Dosage] for details. Precautions for pregnancy and lactation: Oral administration of nearly lethal doses of vitamin D by pregnant rabbits produced aortic valve stenosis in the fetus. Pregnant women should weigh the pros and cons when using this product. It is speculated that exogenous calcitriol can be secreted into breast milk. Considering the potential for hypercalcemia in mothers and the adverse effects of this product on breastfeeding infants, mothers can breastfeed while taking this product if the blood calcium concentration of mothers and infants is monitored. Precautions for the elderly: See [Usage and Dosage] for details.

1. Since calcitriol is one of the most important metabolites of vitamin D3, it is forbidden to use pharmacological doses of vitamin D and its derivatives during calcitriol treatment to avoid possible additive effects and hypercalcemia. 2. Patients should be given dietary guidance, especially to observe calcium intake and control the use of calcium-containing preparations. 3. Combination with thiazole diuretics will increase the risk of hypercalcemia. The dosage of calcitriol should be carefully formulated for patients who are currently receiving digitalis treatment, because such patients may induce arrhythmias if hypercalcemia occurs. 4. There is a functional antagonistic relationship between vitamin D analogs and hormones. Vitamin D preparations can promote calcium absorption, while hormone preparations inhibit calcium absorption. 5. Magnesium-containing drugs (such as antacids) may cause hypermagnesemia, so patients who are receiving long-term dialysis should not take such drugs when using this product for treatment. 6. Since this product affects the transport of phosphorus in the intestine, kidney and bones, the dosage of phosphorus-binding preparations should be adjusted according to the blood phosphorus concentration (normal value 2-5mg/100ml, or 0.6-1.6mmol/l). 7. Patients with vitamin D-resistant rickets (familial hypophosphatemia) should continue to take oral phosphorus preparations. However, it should be considered that calcitriol may stimulate intestinal phosphorus absorption, because this effect may change the phosphorus requirement. 8. The use of enzyme inducers such as diphenylhydantoin or phenobarbital may increase the metabolism of calcitriol and reduce its blood concentration. If such preparations are taken at the same time, the dosage of calcitriol should be increased. 9. Cholestyramine can reduce the absorption of fat-soluble vitamins in the intestine, so it may induce poor absorption of calcitriol in the intestine.

Keep in a dark, airtight container and dry place below 25℃.

0.25 micrograms/capsule

36 months