Product Overview
Generic name: calcitriol capsules
Chinese Pinyin: GuHuaSanChunJiaoWan
English name: Calcitriol Soft Capsules
Product name: Luo Gai Quan
Ingredients: The main ingredient of this product is calcitriol.
Properties: This product is a capsule containing a yellow or yellow oily liquid.
Indications: 1. Osteoporosis after menopause;
2. Chronic renal failure, especially renal osteodystrophy in patients undergoing hemodialysis;
3. Postoperative hypoparathyroidism;
4. Idiopathic hypoparathyroidism;
5. False hypoparathyroidism;
6. Vitamin D dependent rickets;
7, hypophosphatemic vitamin D-resistant rickets, etc.
Specification: 0.25μg*10 capsules/box
Usage and dosage: The daily optimal dosage of this product should be carefully formulated 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. After taking the medicine, the blood calcium and blood creatinine concentrations were monitored at the 4th week, 3rd month, and 6th month, and every 6 months thereafter.
2. Renal habit osteodystrophy (including dialysis patients): The daily dose at the initial stage is 0.25μg for patients with normal or slightly decreased blood calcium. If there is no significant improvement in the biochemical indicators and condition within 2 to 4 weeks, increase the daily dosage of this product by 0.25 ug 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, in the morning. If there is no significant improvement in biochemical indicators and condition, increase the dose every 2 to 4 weeks. During this period, the blood calcium concentration was measured at least twice. Patients with hypoparathyroidism may occasionally experience poor absorption, so this type of patient requires 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 the dose should be reduced in the postpartum and lactation period.
4. Elderly patients: Elderly patients do not need a special dose, but it is recommended to monitor blood calcium and blood creatinine concentrations.
5. Infants and children: The solution formulation of this product is suitable for infants and children. As with the same, the optimal daily dose should be determined on the basis of blood calcium levels. For children under 2 years old, the recommended daily reference dose is 0.01-0.1 ug/kg body weight. The measuring tube equipped in the package can accurately measure the dose required by each patient. The administration volume can be in milliliters or drops: 0.1 mL of solution is equivalent to 0.1 ug of active ingredient (calcitriol), or 1 drop of solution contains 0.02 ug of calcitriol. The solution can be put into a spoon first and then mixed into children's beverages (such as orange juice, etc.).
Adverse reactions: As calcitriol can produce vitamin D, the possible adverse reactions are similar to those of vitamin D overdose, such as hypercalcemia syndrome or calcium poisoning (depending on the severity and duration of hypercalcemia). Occasionally, acute symptoms include loss of appetite, headache, vomiting, and constipation. Chronic symptoms include malnutrition, sensory disturbances, fever with thirst, excessive urination, dehydration, apathy, stunting, and urinary tract infections. Up to 15 years of clinical use of this product for all indications, the results show that the incidence of adverse reactions is very low, including hypercalcemia, the incidence is 0.001% or less. Patients with hypercalcemia and hyperphosphatemia (concentrations greater than 6 mg/100 mL or 1.9 mmol/L) may develop soft tissue calcification, which can be observed by radiological examination. In patients with normal renal function, chronic hypercalcemia may be related to increased serum creatinine.
Contraindications: 1. This product is forbidden for diseases related to hypercalcemia, and also for patients who are known to be allergic to this product or similar drugs and any excipients.
2. It is contraindicated in patients with signs of vitamin D poisoning.
Note: 1. Hypercalcemia is closely related to the treatment of this product. Studies on patients with uremic osteodystrophy show that up to 40% of patients treated with calcitriol have hyperemia. Dietary changes (for example: increasing the intake of dairy products) and even rapid increases in calcium intake or uncontrolled use of calcium preparations can cause hypercalcemia. Patients and their families should be informed that they must strictly follow the prescribed diet and teach them how to recognize 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 blood creatinine rises to more than 120umol/ml, stop taking this product immediately until the blood calcium is normal. In patients with normal function, chronic hypercalcemia may be related to increased blood anhydride. Bedridden patients, such as postoperative bedridden patients, have a greater chance of developing hypercalcemia.
2. Calcitriol can increase the level of inorganic phosphorus in the blood. At this time, patients with hypophosphatemia are beneficial, but for patients with renal failure, beware of the danger caused by abnormal calcium precipitation. Under the circumstances, it is necessary to maintain the blood phosphorus at a normal level (2~5mg/100ml or 0.65~1.62mmol/l) by taking an appropriate amount of phosphorus binder or reducing the phosphorus intake. Patients suffering from vitamin D-resistant rickets (familial hypophosphatemia) should continue to take phosphorus preparations when treated with this product. However, it must be considered that this product may promote the absorption of phosphorus in the intestine, and this effect may reduce the intake of phosphorus. Therefore, it is necessary to perform a stable period regularly, and measure blood calcium at least twice a week.
3. Since calcitriol is the most effective vitamin D metabolite available, it is not necessary to use other vitamin D preparations in combination with it to avoid hypervitamin Demia. If the patient changes from taking vitamin D3 to calcitriol, it may take several months for the blood vitamin D3 to return to the basic level.
4. Patients with normal renal function must avoid dehydration when taking this product, so they should maintain proper water intake.
5. Impact on driving vehicles and operating machinery, based on the reported pharmacodynamic characteristics of adverse reactions, it is inferred that this product is safe or has little impact on driving vehicles and operating machinery.
Drug interactions: As one of the most important metabolites of vitamin D3 of calcitriol, it is prohibited to use pharmacological doses of vitamin D and its derivatives during calcitriol treatment to avoid possible additional effects And hypercalcemia. It is necessary to give dietary guidance to patients, especially to observe the intake of calcium and to control the use of calcium-containing preparations. Combined use with thiazole diuretics will increase the risk of hypercalcemia. For patients undergoing digitalis therapy, the dosage of calcitriol should be carefully formulated, because such patients may experience hypercalcemia if hypercalcemia occurs The new rhythm is out of order. 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 have been on long-term dialysis should not take these drugs when using this product for treatment. Since this product affects the transport of phosphorus in the intestines, kidneys and bone marrow, the dosage of phosphorus-bound 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 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 malabsorption of triol in the intestine.
Pharmacology and Toxicology: Calcitriol is one of the most important active metabolites of vitamin D3. It is usually converted in the kidney from its precursor 25-hydroxyvitamin D3 (25-HCC). The normal daily production amount is 0.5-1.0 ug, and during the period of increased bone synthesis (such as growth period or pregnancy period) its production volume increases slightly. Calcitriol promotes the absorption of calcium in the intestines and regulates bone mineralization. The pharmacological effects of a single dose of calcitriol can last 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. Patients with renal osteodystrophy orally take this product to normalize the intestinal absorption of calcium, correct hypocalcemia, and excessive blood alkaline phosphatase and blood parathyroid hormone concentrations. This product can reduce bone and muscle pain, and correct histological changes that occur in patients with fibrous osteitis and other insufficient mineralization. The level of calcitriol in the blood of patients with vitamin D-dependent rickets is reduced or absent. 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 hypophosphatemia, blood calcium levels are reduced. The treatment of this product can reduce the tubular clearance of phosphorus, and combined with the treatment of phosphorus preparations, restore bone growth. Even at very high doses, there is no evidence that vitamin D has teratogenic effects in humans.
Pharmacokinetics: Due to the short biological half-life of calcitriol, its pharmacokinetic studies have shown that the increased blood calcium will return to the normal range after stopping or reducing the dose for a few days. This process is much faster than vitamin D3 . Allergic reactions may occur to patients with sensitive constitutions.
Storage: shading, airtight, store below 30℃. Medicines should be stored out of the reach of children.
Packing: 10 capsules/bottle.
Validity period: 36 months
Approval number: National Medicine Standard J20150011
Company Name: Shanghai Roche Pharmaceutical Co., Ltd.
