Calcitriol Soft Capsules

Calcitriol's key role in regulating calcium homeostasis, including stimulation of osteoblast activity in the skeleton, provides a sufficient pharmacological basis for the treatment of osteoporosis. Oral administration of this drug to patients with renal osteodystrophy normalizes intestinal calcium absorption, corrects hypocalcemia, and excessive blood alkaline phosphatase and parathyroid hormone concentrations. This drug can relieve bone and muscle pain and correct histological changes that occur in patients with osteitis fibrosa and other mineral deficiency[1]. Patients with vitamin D-dependent rickets have reduced or absent blood calcitriol levels. Since calcitriol production in the kidneys is insufficient, this drug may be considered as an alternative treatment. In patients with vitamin D-resistant rickets and hypophosphatemia, blood calcium levels are reduced, and treatment with this drug can reduce tubular clearance of phosphate and, in combination with treatment with phosphate preparations, restore bone growth. There is no evidence that vitamin D is teratogenic in humans, even at very high doses.

The main ingredient of this product is calcitriol.

The content of this product is light yellow to 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.

Usage: Oral. 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. After determining the optimal dose of this product, the blood calcium level should be checked once a month (or refer to the detailed description of 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) by 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 returns to normal. During the period of increased blood calcium, blood calcium and blood phosphorus levels must be measured daily, and blood calcium is normal.

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 diseases related to hypercalcemia, patients with known allergies to this product or its counterparts and any of its excipients; and patients with signs of vitamin D poisoning.

Precautions for children: Not yet clear. Precautions for pregnancy and lactation: Not yet clear. Precautions for the elderly: Not yet clear.

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. Co-administration with thiazolidine 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 arrhythmias 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 high

Keep away from light and sealed.

0.5 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

• Email:

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