Calcium-D3-MIC capsules 66.7 IU/166.7 mg №10×6

Name Calcium-D3-MIC caps. Observation is especially important in elderly patients with simultaneous treatment with cardiac glycosides and diuretics (see the section “Interaction with other drugs”) and in patients with an increased tendency to form kidney stones. In cases of hypercalcemia or signs of impaired renal function, reduce the dose or stop treatment. Vitamin D should be taken with caution in patients with renal insufficiency. In this case, it is necessary to control the content of calcium and phosphates in the blood serum. It is also necessary to take into account the risk of soft tissue calcification. In order to avoid overdose, it is necessary to take into account the additional intake of vitamin D from other sources. Calcium and vitamin D3 should be used with caution in immobilized patients with osteoporosis due to the risk of hypercalcemia. Vitamin D should be taken with caution in patients with sarcoidosis, as they have abnormal vitamin D metabolism and may develop hypercalcemia, kidney stones, and kidney failure. The concentration of calcium in the blood and urine should be checked regularly in such patients. Simultaneous use with antibiotics of the tetracycline or quinolone group is usually not recommended, or should be carried out with caution (see section “Interaction with other drugs”). The use of large doses of vitamin D3 is impractical, since the vitamin in these cases inhibits the formation of biologically active compounds of vitamin D3. At the same time, the percentage of unconverted vitamin D3 in the body increases, which undergoes oxidation and thereby increases the risk of D-hypervitaminosis. The composition of the shell of the gelatin capsule includes the dye “sunset” yellow E-110, which can cause allergic reactions. Pharmacological propertiesPharmacodynamicsCalcium-D3-MIC is a combined drug that regulates the exchange of calcium and phosphorus. Calcium is a vital mineral element necessary for maintaining the balance of electrolytes in the body and the adequate functioning of regulatory mechanisms. Calcium carbonate is involved in the formation of bone tissue, is necessary for the mineralization of teeth, the regulation of nerve conduction, muscle contractions, maintaining stable cardiac activity and is a component of the blood coagulation system. Calcium (in ionized form and in the form of complexes) plays a key role in cell division and differentiation, conduction of nerve impulses and in the contraction-relaxation cycle (together with tropin) of smooth and striated muscles, transmembrane ion reactions involving selective calcium channels, activity neuroselective organs, the production and effects of a number of hormones, enzymes and other protein, as well as non-protein biologically active substances. The participation of calcium in such diverse processes is explained by its universal function as a secondary messenger (transmitter) that transmits and implements a biological signal in cells of various types. Vitamin D3 stimulates the absorption of calcium and phosphorus in the intestine, the reabsorption of calcium and phosphorus in the kidneys, the transport of calcium through membranes and cells, the development of the immune system, cell proliferation and differentiation, the synthesis of lipids and a number of hormones, the functional activity of the cardiovascular system and the gastrointestinal tract , reduces the level of parathyroid hormone in the blood. It is necessary for the normal functioning of the parathyroid glands, takes part in the synthesis of ATP. Vitamin D3 and its active metabolites have a multifaceted effect on bone tissue: they increase calcium absorption in the intestine, stimulating the synthesis of calcium-binding proteins; increase calcium reabsorption in the renal tubules; activate the processes of bone remodulation by increasing the synthesis of collagen I and matrix proteins, by activating the synthesis of osteoblasts; improve bone quality by influencing osteoclast activity; regulate the secretion of parathyroid hormone by two mechanisms: directly suppressing the proliferation of parathyroid cells and through an increase in the level of calcium in the blood; stimulate the differentiation of cells – precursors of bone and cartilage tissues; have a positive effect on neuromuscular conduction through the regulation of calcium channels and protein kinase A activity. The use of a combined preparation containing calcium and vitamin D3 is justified, since vitamin D3 increases the absorption of calcium in the intestine and the combined use of calcium and vitamin D3 prevents an increase in the production of parathyroid hormone (PTH ), which is a stimulant of increased bone resorption (leaching of calcium from the bones). Thus, Calcium-D3-MIC regulates calcium and phosphate metabolism, reduces resorption and increases bone density, compensates for the lack of calcium and vitamin D3 in the body, enhances calcium absorption in the intestine and phosphate reabsorption in the kidneys, promotes bone mineralization. Pharmacokinetics Calcium. Calcium absorption occurs in the duodenum, jejunum and large intestine. This process is carried out with the participation of two mechanisms: active absorption and passive diffusion, with the participation of which less than 10% of the element supplied with food is absorbed. The main regulator of active absorption is a vitamin D metabolite, calcitriol, which stimulates the biosynthesis of calcium-binding proteins in intestinal enterocytes. After being absorbed into the systemic circulation, calcium is distributed among organs and systems and, first of all, enters the bone tissue. Under physiological conditions, the excretion of calcium from the body (except for the part that is not absorbed in the intestines excreted with feces) is approximately 250–300 mg per day, which includes 140–180 mg that have not been reabsorbed in the kidneys and enter the urine, as well as 80–100 mg, excreted in the intestines with bile and pancreatic secretions. Calcium absorption increases during pregnancy and lactation. Penetrates through the placental barrier, excreted in breast milk. Cholecalciferol. Absorption of cholecalciferol occurs in the small intestine in the presence of bile. Usually 50-70% of the accepted dose of the vitamin is absorbed. Incomplete absorption is observed with obstructive jaundice and severe steatorrhea. The maximum concentration is reached in 8-18 hours. From the bloodstream, about 70% of vitamin D3 is taken up by the liver, where it is metabolized. The resulting metabolite (25-hydroxycholecalciferol) is transported to the kidneys, where the formation of biologically active compounds occurs, among which 1,25-dihydroxycholecalciferol (1,25 (OH) 2 D3) and 24,25-dihydroxycholecalciferol (24, 25(OH)2D3). The metabolism of cholecalciferol is impaired in chronic renal failure, with the appointment of inhibitors of protein synthesis (actinomycin, glucocorticoids), with prolonged use of phenobarbital and diphenin. Vitamin D3 has cumulative properties. It accumulates in the liver in non-parenchymal cells, from where it is transported to hepatocytes, where it is metabolized. Penetrates through the placental barrier, excreted in breast milk. T 1/2 from blood plasma is up to several days and may be longer in case of impaired renal function. In elderly patients, a decrease in kidney function is possible, which should be taken into account when dosing the drug. In patients with chronic liver failure, hypocalcemia may be due to a decrease in the synthesis of 25-hydroxy-cholecalciferol in the liver as a substrate for the formation of 1,25-dihydroxy-cholecalciferol in the kidneys, that is, vitamin D-hormone that increases intestinal absorption of ionized calcium. Chronic renal failure is accompanied by a decrease in the synthesis of vitamin D-hormone, which in some patients causes hypocalcemia. In patients with nephrotic syndrome, urinary loss of 25-hydroxycholecalciferol leads to hypocalcemia. Hypocalcemia due to loss of 25-hydroxycholecalciferol can be caused by blockade of its physiological circulation between the intestinal lumen and the liver, due to a decrease in intestinal absorption. Indications for useAs a therapeutic and prophylactic agent, Calcium-D3-MIC is used: in conditions of calcium and vitamin D3 deficiency in the body associated with malnutrition, when the intake of calcium and cholecalciferol with food is not enough; with an increased body’s need for calcium and vitamin D3 during pregnancy and during breastfeeding, as well as in children over 12 years of age during a period of intensive growth; for the prevention of osteoporosis (menopausal, senile, steroid, idiopathic, etc.) and its complications (bone fractures), as an addition to any specific osteoporosis therapy. Method of application and dosesCalcium-d3-mic instructions for use. Adults and children over 12 years of age are prescribed 2-3 capsules 2 times a day in the morning and evening, mainly during meals. Dosage regimen for children under 12 years of age in accordance with the doctor’s recommendations. Duration of treatment: When used for prevention and in the complex therapy of osteoporosis, the duration of treatment is determined by the doctor individually. When used to compensate for the deficiency of calcium and vitamin D3, the average duration of the course of treatment is at least 4-6 weeks. The number of repeated courses during the year is determined individually. Patients with impaired liver function: Dose adjustment is not required. Patients with impaired renal function: Calcium-D3-MIC should not be used in severe renal insufficiency. Elderly patients: The dose is the same as for adults. A possible decrease in kidney function should be taken into account. Use during pregnancy and lactation When prescribing the drug during pregnancy, it should be borne in mind that the daily dose of calcium should not exceed 1500 mg, and cholecalciferol – 600 IU. An overdose during pregnancy can lead to a violation of the mental and physical development of the child. Cholecalciferol and its metabolites may be excreted in breast milk. This should be taken into account if the child additionally receives vitamin D. Interaction with other drugs Hypercalcemia can potentiate the toxic effects of cardiac glycosides when used simultaneously with calcium and vitamin D3 preparations. It is necessary to control the ECG and the content of calcium in the blood serum. Calcium preparations can reduce the absorption of tetracyclines from the gastrointestinal tract. Therefore, tetracycline drugs should be taken at least 2 hours before or 4-6 hours after taking Calcium-D3-MIC. To prevent a decrease in the absorption of bisphosphonate preparations, it is recommended to take them at least one hour before taking Calcium-D3-MIC. Glucocorticosteroids reduce calcium absorption, so treatment with glucocorticosteroids may require an increase in the dose of Calcium-D3-MIC. With the simultaneous use of thiazide diuretics, the risk of hypercalcemia increases, because. they increase tubular reabsorption of calcium. With the simultaneous use of thiazide diuretics, the calcium content in the blood serum should be regularly monitored. Furosemide and other loop diuretics, on the contrary, increase the excretion of calcium by the kidneys. Calcium reduces the effectiveness of levothyroxine by reducing its absorption. The period of time between taking levothyroxine and Calcium-D3-MIC should be at least 4 hours. The absorption of antibiotics of the quinolone group is reduced with simultaneous use with calcium preparations. Therefore, antibiotics of the quinolone group should be taken 2 hours before or 6 hours after taking Calcium-D3-MIC. The activity of cholecalciferol may decrease with its simultaneous use with phenytoin or barbiturates. Cholestyramine and laxatives based on mineral or vegetable oil reduce the absorption of vitamin D3. The intake of foods containing oxalates (sorrel, rhubarb, spinach) and phytin (cereals) reduces the absorption of calcium, therefore, Calcium-D3-MIC should not be taken within two hours after eating sorrel, rhubarb, spinach, cereals. ContraindicationsContraindications for use are: hypersensitivity; hypercalcemia (including as a result of hyperparathyroidism (primary or secondary)); hypercalciuria; hypervitaminosis D3; nephrolithiasis; decalcifying tumors such as myeloma, bone metastases, sarcoidosis; urolithiasis disease; osteoporosis due to immobilization; atherosclerosis; Hypersensitivity to the active substances or to any of the excipients. This dosage form is not prescribed for children under 6 years of age. CompositionCholecalciferol (in the form of cholecalciferol type 100 CWS) – 66.7 IU, calcium (in the form of calcium carbonate) – 166.7 mg. Overdose Overdose symptoms: anorexia, thirst, polyuria, muscle weakness, nausea, vomiting, constipation, abdominal pain, fatigue, bone pain, mental disorders, nephrocalcinosis, urolithiasis and, in severe cases, cardiac arrhythmias. With prolonged use of excess doses (over 2500 mg of calcium) – kidney damage, soft tissue calcification. If signs of an overdose are found, it is necessary to stop taking calcium and vitamin D, as well as thiazide diuretics and cardiac glycosides. Treatment: gastric lavage, fluid replacement, loop diuretics (eg, furosemide), glucocorticosteroids, calcitonin, bisphosphonates. It is necessary to control the content of electrolytes in the blood plasma, kidney function and diuresis. In severe cases, it is necessary to measure central venous pressure (CVP) and monitor the electrocardiogram (ECG). Side effect From the digestive system: constipation or diarrhea, flatulence, nausea, abdominal pain. From the side of metabolism: rarely – hypercalcemia and hypercalciuria. Other: allergic reactions. Storage conditions Do not use after the expiry date stated on the packaging. To store in the place protected from moisture and light at a temperature from 15 °C to 25 °C. Keep out of the reach of children. Buy Calcium-D3-MIC capsules 66.7 IU / 166.7 mg No. 10×6 .7IU / 166.7mg No. 10×6