Calcitriol Soft Capsules

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 0.5~1.0ug, and its growth rate 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. The key role of calcitriol in regulating calcium balance, including the stimulation of osteoblast activity in bones, provides a sufficient pharmacological basis for the treatment of osteoporosis. For patients with renal osteodystrophy, oral administration of this product can restore the intestinal ability 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 mineral deficiency. 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. In patients with vitamin D-resistant rickets and hypophosphatemia, the blood calcium level is reduced. This product can reduce the tubular elimination of phosphorus and restore bone growth in combination with treatment with phosphorus preparations. Even at very high doses, there is no evidence that vitamin D has teratogenic effects on humans.

Calcitriol.

This product is a capsule containing yellow or light yellow oily liquid.

1. Postmenopausal osteoporosis; 2. Chronic renal insufficiency; 3. Postoperative hypothyroidism; 4. Idiopathic hypoparathyroidism; 5. Pseudohypothyroidism; 6. Vitamin D-dependent rickets; 7. Hypophosphatemic vitamin D-resistant rickets, etc.

The optimal daily dose of this product should be carefully determined based on 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 dose should not be increased without monitoring the blood calcium level. 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). A tourniquet should not be used when collecting blood calcium samples. If the blood calcium exceeds the normal range (9~11mg/100ml or 2250~2750umol/l) 1mg/100ml (250umol/l), or the blood creatinine is greater than 120umol/l, the dose must be reduced or treatment must be completely discontinued until the blood calcium is normal. During the period of increased blood calcium, blood calcium and blood phosphorus levels must be measured daily. This product can be taken after the blood calcium is normal, but the daily dose should be 0.25ug lower than the previous dose. The daily calcium intake should be estimated and adjusted as appropriate. The prerequisite for the best efficacy of this drug is sufficient but not excessive calcium intake (adults: about 800 mg per day). Calcium supplementation is necessary at the beginning of treatment. 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. 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 0.25ug each time, three times a day. After taking the drug, monitor 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 0.25ug. Patients with normal or slightly reduced blood calcium can take 0.25ug every other day. If there is no significant improvement in biochemical indicators and condition within 2 to 4 weeks, increase the daily dosage of this product by 0.25ug every 2 to 4 weeks, and measure blood calcium at least twice a week during this period. The optimal dosage for most patients is between 0.5 and 1.0ug per day. 3 Hypothyroidism and rickets: The recommended starting dose is 0.25ug per day, taken in the morning. If there is no significant improvement in biochemical indicators and condition, increase the dosage every 2 to 4 weeks. During this period, measure blood calcium concentration at least twice a week. Patients with hypoparathyroidism occasionally have poor absorption, so such patients need a larger dose or follow the doctor's advice.

Since calcitriol can produce the effects of vitamin D, the 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 indifference, developmental arrest and urinary tract infection. This product has been used clinically for up to 15 years to treat all indications. The results showed that the incidence of adverse reactions was very low, including hypercalcemia, with an incidence of 0.111% or less. Patients with concurrent hypercalcemia and hyperphosphatemia (concentration greater than 6mg/100mmol/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. Due to the short biological half-life of calcitriol, its pharmacokinetic studies have shown that elevated blood calcium returns to the normal range after discontinuation or reduction of the dose for several days, a process that is much faster than vitamin D3. Allergic reactions may occur in sensitive patients.

This product is contraindicated in patients with signs of vitamin D toxicity.

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.

Since calcitriol is one of the most important metabolites of vitamin D3, pharmacological doses of vitamin D and its derivatives are prohibited during calcitriol treatment to avoid possible additive effects and hypercalcemia. Patients should be given dietary guidance, especially to observe calcium intake and control the use of calcium-containing preparations. 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 develop arrhythmia if hypercalcemia occurs. 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. 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. Since this product affects the transport of phosphorus in the intestine, kidney and bone marrow, 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). 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. The use of enzyme inducers such as diphenylhydantoin or phenobarbital may increase the poor absorption of triol in the intestine.

Keep in a dark, airtight, cool place.

0.25 μg

36 months

Qingdao Guoxin Pharmaceutical Co., Ltd.

• Founded in:

  1994-11-24

• Address:

  No. 3601, Tuanjie Road, Qingdao Economic and Technological Development Zone

• Tax NO.:

  91370211614316886Y

• Registered Funds:

  62.748 million yuan

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