Calcitriol Soft Capsules

This medicine is an artificially produced calcitriol, which is made into a sterile isotonic clear aqueous solution for intravenous injection. In addition to the active ingredient, this medicine also contains 20.4 mg of polyoxyethylene sorbitan fatty acid ester; 1.5 mg of sodium chloride; 10 mg of sodium ascorbate; 7.6 mg of anhydrous sodium dihydrogen phosphate; 1.8 mg of sodium monohydrogen phosphate monohydrate; and 1.1 mg of disodium edetate. The pH value is close to pH 7.2 (6.5-8.0). Calcifol is a colorless crystalline compound that exists naturally in the human body. It is soluble in organic solvents but not very soluble in water. Its chemical name is 9,10-opened cholesterol-5,7,10⒆-triene-1-α-3-β25 trione, and its common name is 1-α-25-dihydroxycholecalciferol or 1-α-25-dihydroxyvitamin D3. Calcifol is a pharmacologically active substance derived from vitamin D3 (cholecalciferol). Vitamin D is supplied naturally or endogenously, and humans mainly rely on violet When exposed to external light, the skin converts 7-dehydrocholesterol into vitamin D3. Before vitamin D3 can fully act on its target tissues, it must be metabolized in the liver and kidneys. The first conversion requires the catalysis of vitamin D325-hydroxylase in the liver to produce 25-hydroxy-D3. The next hydroxylation occurs in the mitochondria of kidney tissue, and through the activation of the kidney's 25-hydroxyvitamin D31-α-hydroxylase, the reaction produces 1,25-dihydroxy D3, which is the effective form of vitamin D3. The sites of action of calcitriol are the small intestine, bones, kidneys and parathyroid glands. It can stimulate the small intestine's calcium transport function and promote the small intestine's calcium absorption. It can also synergize with parathyroid hormone to promote the reabsorption of calcium without increasing the renal tubular reabsorption of calcium. Calcitriol can also directly inhibit the synthesis and secretion of parathyroid hormone. Patients with uremia will develop anti-vitamin D because when renal failure occurs, the precursor of calcitriol cannot be converted into the active compound calcitriol.

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 possible should be used and the dose should not be increased without monitoring the blood calcium level.

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 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.

Do not use with antacids containing magnesium.

Keep in a dark and closed place in a cool place.

0.25 μg

36 months