Please read the instructions carefully and use them under the guidance of a physician.
Common name : Calcitriol capsules
Chinese Pinyin : GuHuaSanChunJiaoWan
English name : Calcitriol Soft Capsules
Product Name : Luo Gaiquan
Ingredients: The main component of this product is calcitriol.
Properties: This product is a gelatin capsule containing yellow or yellow oily liquid.
Indications: 1, postmenopausal osteoporosis;
2. Chronic renal failure, especially renal osteodystrophy in patients undergoing hemodialysis;
3. Postoperative hypoparathyroidism is low;
4. Idiopathic hypoparathyroidism is low;
5, pseudo-hypoparathyroidism is low;
6, vitamin D-dependent rickets;
7, low blood phosphorus vitamin D resistance type rickets and so on.
Specifications : 0.25μg*10 tablets / box
Dosage: The daily optimal dose of this product should be carefully prepared according to the blood calcium level of each patient. Oral, the specific method is as follows:
1. Postmenopausal osteoporosis: The recommended dose is 0.25ug each time, three times a day. Blood calcium and serum creatinine concentrations were monitored at 4 weeks, 3 months, and 6 months after administration, and monitored every six months thereafter.
2, kidney habitual bone dystrophy (including dialysis patients): the initial dose of the initial dose of 0.25u g of normal or slightly reduced blood calcium can be 0.25ug every other day. If the biochemical indicators and the condition have not improved significantly within 2~4 weeks, the daily dosage of the product will be increased by 0.25ug every 2~4 weeks, during which blood calcium is measured at least twice a week. The optimal dose for most patients is between 0.5 and 1.0 ug per day.
3, hypothyroidism and rickets: the recommended starting dose of 0.25ug daily, morning clothes. If the biochemical indicators and the condition did not improve significantly, the dose was increased every 2 to 4 weeks. During this period, at least the blood calcium concentration was measured twice per catch. Patients with hypoparathyroidism occasionally have poor absorption, so this patient needs a larger dose. If the doctor decides to treat this product for pregnant women with hypoparathyroidism, increase the dose during the second trimester and reduce the dose during postpartum and lactation.
4. Elderly patients: Older patients do not need special doses, but it is recommended to monitor blood calcium and serum creatinine concentrations.
5. Infants and Children: The solution dosage form of this product is suitable for infants and children. As with the determination, the daily optimal dose should be determined based on the blood calcium level. For children under 2 years of age, the recommended daily reference dose is 0.01-0.1 ug / kg body weight. The measuring tube provided in the package accurately measures the dose required for each patient. The dosing volume can be in milliliters or drops: 0.1 mL of solution corresponds to 0.1 ug of active ingredient (calciferol), or 1 drop of solution contains 0.02 ug of calcitriol. The solution can be placed in a spoon and then mixed into a child's drink (eg orange juice, etc.).
Adverse reactions: Since calcitriol can produce vitamin D, the possible adverse reactions are similar to vitamin D excess, 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 disturbances, fever associated with thirst, excess urine, dehydration, apathy, developmental arrest, and urinary tract infections. The clinical use of this product for 15 years has been used to treat all indications. The results show that the incidence of adverse reactions is very low, including the incidence of hypercalcemia is 0.001% or lower. Soft tissue calcification may occur in patients with high calcium and hyperphosphatemia (concentrations greater than 6 mg/100 mL or 1.9 mmol/L), which can be observed by radiological examination. In patients with normal renal function, chronic hypercalcemia may be associated with increased serum creatinine.
Contraindications: 1. This product is contraindicated in diseases associated with hypercalcemia and is also contraindicated in patients who are known to be allergic to this product or similar drugs and any of its excipients.
2. Disabled for patients with signs of vitamin D poisoning.
Note: 1, high blood calcium is closely related to the treatment of this product. Studies of patients with uremic bone dystrophy have shown that hyperemia is found in up to 40% of patients treated with calcitriol. Dietary changes (eg, increased intake of dairy products) and the rapid increase or uncontrolled calcium intake of calcium can result in hypercalcemia. Patients and their families should be informed that they must strictly follow the prescribed diet and teach them how to identify the symptoms of hypercalcemia. Once the blood calcium concentration is 1ml/100ml higher than the normal value (9~11mg/100ml, or 2250~2750ug mol/l), or the serum creatinine is increased to more than 120umol/ml, stop taking this product immediately until the blood calcium normal kidney In patients with normal function, chronic hypercalcemia may be associated with increased blood anhydride. Patients with bedridden, such as postoperative bedridden patients, have a greater chance of developing hypercalcemia.
2, calcitriol can increase blood inorganic phosphorus levels, when patients with hypophosphatemia are beneficial, but for patients with renal failure, beware of the dangers caused by abnormal calcium precipitation, in this In this case, blood phosphorus should be kept at a normal level (2~5mg/100ml or 0.65~1.62mmol/l) by oral administration of appropriate amount of phosphorus binder or reduction of phosphorus intake. Patients with vitamin D-resistant sputum (familial hypophosphatemia) should continue oral phosphorus preparation when treated with this product. However, it must be considered that this product may promote the absorption of phosphorus in the intestine, which may reduce the phosphorus intake requirement. Therefore, it is necessary to carry out a stable period on a regular basis, and at least two blood calcium levels are measured every week.
3. Since calcitriol is the most effective vitamin D metabolite available, it does not require other vitamin D preparations to be used in combination to avoid hypervitaminosis. If the patient is taking calcitriol from vitamin D3, it may take several months to restore the blood to vitamin D3 to the basal level.
4. Patients with normal renal function must avoid dehydration when taking this product, so proper water intake should be maintained.
5. The impact on the driving vehicle and the operating machine, based on the reported pharmacodynamic characteristics of the adverse reactions, it is speculated that the product is safe or has little effect on driving the vehicle and operating the machine.
Drug Interactions: Due to one of the most important metabolites of calcitriol vitamin D3, pharmacological doses of vitamin D and its derivatives are prohibited during calcitriol treatment to avoid possible additional effects. And hypercalcemia. Diet guidance should be given to patients, especially to observe calcium intake and to control the use of calcium-containing preparations. In combination with thiazole diuretics, the risk of hypercalcemia is increased. For patients undergoing digitalis treatment, the amount of calcitriol should be carefully established because such patients may develop hypercalcemia if hypercalcemia occurs. The new law is dysfunctional. There is a functional antagonism between vitamin D analogues and hormones. Vitamin D preparations promote calcium absorption, while hormonal preparations inhibit calcium absorption. Magnesium-containing drugs (such as antacids) may cause hypermagnesemia, so patients who have been on dialysis for a long time cannot take these drugs when using this product. Since this product affects the transport of phosphorus in the intestine, kidney and bone marrow, the amount of phosphorus-binding preparation should be adjusted according to the blood phosphorus concentration (normal value 2~5mg/100ml or 0.6~1.6mmol/l). Vitamin D patients with anti-caries (familial hypophosphatemia) should continue oral phosphorus preparations. However, it should be considered that calcitriol may stimulate intestinal phosphorus uptake, as this effect may alter the amount of phosphorus required. The use of enzyme inducers such as diphenylacetamide or phenobarbital may increase the absorption of triol in the intestine.
Pharmacology and Toxicology: Calcitriol is one of the most important active metabolites of vitamin D3. It is usually transformed from the precursor 25-hydroxyvitamin D3 (25-HCC) in the kidney. The normal physiological daily production is 0.5-1.0 ug, and the amount of production increased slightly during the period of increased bone synthesis (such as growth period or pregnancy). Calcitriol promotes intestinal absorption of calcium and regulates bone mineralization. The pharmacological effects of a single dose of calcitriol can last approximately 3-5 days. The key role of calcitriol in regulating calcium balance, including the stimulation of osteoblast activity in bone, provides a sufficient pharmacological basis for the treatment of osteoporosis. Patients with renal osteodystrophy take this product to normalize the ability of the intestine to absorb calcium, correct hypocalcemia, and excessive blood alkaline phosphatase and blood parathyroid hormone concentrations. This product reduces bone and muscle pain and corrects histological changes in patients with fibrotic osteitis and other mineralized deficiencies. Patients with vitamin D-dependent rickets have reduced or absent levels of calcitriol in their blood. Due to insufficient production of calcitriol in the kidney, this product can be considered as an alternative treatment. In patients with vitamin D-resistant rickets and patients with hypophosphatemia, blood calcium levels are reduced. This product treatment can reduce the tubular clearance of phosphorus and combine the treatment of phosphorus preparations to restore bone growth. Even at very high doses, there is no evidence that vitamin D is teratogenic to humans.
Pharmacokinetics: Because of the short biological half-life of calcitriol, its pharmacokinetic studies have shown that elevated calcium levels return to normal range after several days of withdrawal or reduction, a process much faster than vitamin D3. . Allergic reactions may occur in patients with sensitive constitutions.
Storage: Shading, sealed, stored below 30 °C. Drugs should be kept out of reach of children.
Packing : 10 capsules / bottle.
Validity: 36 months
Approval number : Imported drug registration number: H20091084
Company Name : Hoffmann-La Roche AG
(Basel Hoff, Roche, Switzerland)