Calcium-D3-MIK forte capsules 133.4 me/166.7 mg No. 10x6
Name
Calcium-D3-MIK forte caps. 133.4 IU/166.7 mg in bl. in pack No. 10x6
Release form
Capsules
Dosage
133.4IU/166.7m
special instructions
During long-term therapy, serum calcium and creatinine levels should be monitored. Monitoring is especially important in elderly patients during concomitant treatment with cardiac glycosides and diuretics (see section “Interaction with other drugs”) and in patients with an increased tendency to form kidney stones. In cases of hypercalcemia or signs of renal impairment, reduce the dose or discontinue treatment. Vitamin D should be taken with caution in patients with renal failure. In this case, it is necessary to monitor the calcium and phosphate levels in the blood serum. The risk of soft tissue calcification must also be considered. To avoid overdose, additional vitamin D intake from other sources must be taken into account. 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 because they have abnormal vitamin D metabolism and may develop hypercalcemia, kidney stones and renal failure. Calcium concentrations in the blood and urine should be checked regularly in such patients. Concomitant use with tetracycline or quinolone antibiotics is usually not recommended or should be done with caution (see section “Interaction with other drugs”). The use of large doses of vitamin D3 is not advisable, 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 gelatin capsule shell contains dyes that can cause allergic reactions.
Pharmacological properties
Pharmacodynamics
Calcium-D3-MIC forte is a combination drug that regulates the metabolism of calcium and phosphorus. Calcium is a vital mineral element necessary to maintain 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, 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 various types of cells. Vitamin D3 stimulates the absorption of calcium and phosphorus in the intestines, 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 gastrointestinal tract , reduces the level of parathyroid hormone in the blood. It is necessary for the normal functioning of the parathyroid glands and takes part in the synthesis of ATP. Vitamin D3 and its active metabolites have a multifaceted effect on bone tissue: they increase the absorption of calcium in the intestine, stimulating the synthesis of calcium-binding proteins; increase calcium reabsorption in the renal tubules; activate bone remodeling processes 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 increasing the level of calcium in the blood; stimulate the differentiation of cells - precursors of bone and cartilage tissue; have a positive effect on neuromuscular conduction through the regulation of calcium channels and the activity of protein kinase A. The use of a combination drug 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 stimulator of increased bone resorption (leaching of calcium from bones). Thus, Calcium-D3-MIC forte regulates the exchange of calcium and phosphates, reduces resorption and increases bone density, compensates for the lack of calcium and vitamin D3 in the body, enhances the absorption of calcium in the intestines and the reabsorption of phosphates in the kidneys, and promotes bone mineralization.
Pharmacokinetics
Calcium. Calcium absorption occurs in the duodenum, jejunum and colon. 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 the 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 primarily enters bone tissue. Under physiological conditions, the excretion of calcium from the body (except for the part excreted in feces that is not absorbed in the intestine) is approximately 250–300 mg per day, which includes 140–180 mg that has not undergone reabsorption in the kidneys and enters the urine, as well as 80–100 mg, excreted into the intestines with bile and pancreatic secretions. Calcium absorption increases during pregnancy and lactation. Penetrates the placental barrier and is excreted in breast milk. Cholecalciferol. Absorption of cholecalciferol occurs in the small intestine in the presence of bile. Usually 50-70% of the taken dose of the vitamin is absorbed. Incomplete absorption is observed with obstructive jaundice and severe steatorrhea. The maximum concentration is reached after 8-18 hours. From the bloodstream, about 70% of vitamin D3 is absorbed 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 disrupted in chronic renal failure, with the prescription of protein synthesis inhibitors (actinomycin, glucocorticoids), with long-term use of phenobarbital and diphenine. 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 the placental barrier and is excreted in breast milk. T1/2 from blood plasma is up to several days and may be longer in case of impaired renal function. In elderly patients, renal function may decrease, which should be taken into account when dosing the drug. In patients with chronic liver failure, hypocalcemia may be a consequence of a decrease in the synthesis in the liver of 25-hydroxy-cholecalciferol as a substrate for the formation of 1,25-dihydroxy-cholecalciferol in the kidneys, that is, a vitamin D hormone that increases the 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 a blockade of its physiological circulation between the intestinal lumen and the liver, due to a decrease in intestinal absorption.
Indications for use
As a therapeutic and prophylactic agent, Calcium-D3-MIC forte is used: in conditions of calcium and vitamin D3 deficiency in the body associated with malnutrition, when the intake of calcium and cholecalciferol from food is insufficient; with the body’s increased need for calcium and vitamin D3 during pregnancy and 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 therapy for osteoporosis.
Directions for use and doses
Calcium-d3-mic forte instructions for use. Adults and children over 12 years of age are prescribed 2-3 capsules 2 times a day, morning and evening, mainly during meals. Dosage regimen for children under 12 years of age in accordance with doctor's recommendations. Duration of treatment When used for prevention and in complex therapy of osteoporosis, the duration of treatment is determined by the doctor individually. When used to replenish calcium and vitamin D3 deficiency, the average duration of treatment is at least 4-6 weeks. The number of repeat courses during the year is determined individually. Patients with impaired liver function No dose adjustment is required. Patients with impaired renal function The drug Calcium-D3-MIC forte should not be used in case of severe renal failure. Elderly patients The dose is the same as for adults. A possible decrease in renal function should be taken into account.
Use during pregnancy and lactation
When prescribing the drug during pregnancy, it should be taken into account that the daily dose of calcium should not exceed 1500 mg, and cholecalciferol - 600 IU. An overdose during pregnancy can lead to disruption of the mental and physical development of the child. Cholecalciferol and its metabolites can be excreted in breast milk. This should be taken into account if the child receives additional vitamin D.
Interaction with other drugs
Hypercalcemia may potentiate the toxic effects of cardiac glycosides when used concomitantly with calcium and vitamin D3 supplements. Monitoring of ECG and serum calcium levels is necessary. Calcium supplements may 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 forte. To prevent decreased absorption of bisphosphonate drugs, it is recommended to take them at least an hour before taking Calcium-D3-MIC forte. Glucocorticosteroids reduce the absorption of calcium, so treatment with glucocorticosteroids may require an increase in the dose of Calcium-D3-MIC forte. With simultaneous use of thiazide diuretics, the risk of hypercalcemia increases, because they increase tubular reabsorption of calcium. When thiazide diuretics are used concomitantly, serum calcium levels should be regularly monitored. Furosemide and other loop diuretics, on the contrary, increase calcium excretion by the kidneys. Calcium reduces the effectiveness of levothyroxine by reducing its absorption. The period of time between doses of levothyroxine and Calcium-D3-MIC forte should be at least 4 hours. The absorption of quinolone antibiotics is reduced when used simultaneously with calcium supplements. Therefore, quinolone antibiotics should be taken 2 hours before or 6 hours after taking Calcium-D3-MIC forte. The activity of cholecalciferol may be decreased when used concomitantly with phenytoin or barbiturates. Cholestyramine and laxatives based on mineral or vegetable oil reduce the absorption of vitamin D3. Eating foods containing oxalates (sorrel, rhubarb, spinach) and phytin (cereals) reduces calcium absorption, so you should not take Calcium-D3-MIC forte within two hours after eating sorrel, rhubarb, spinach, and cereals.
Contraindications
Contraindications 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 caused by immobilization; atherosclerosis; hypersensitivity to the active substances or to any of the excipients. This dosage form is not prescribed to children under 6 years of age.
Compound
Cholecalciferol (in the form of cholecalciferol type 100 CWS) – 133.4 IU, calcium (in the form of calcium carbonate) – 166.7 mg.
Overdose
Symptoms of overdose: anorexia, thirst, polyuria, muscle weakness, nausea, vomiting, constipation, abdominal pain, fatigue, bone pain, mental disorders, nephrocalcinosis, urolithiasis and, in severe cases, cardiac arrhythmias. With long-term use of excessive doses (over 2500 mg of calcium) - kidney damage, soft tissue calcification. If signs of overdose are detected, it is necessary to stop taking calcium and vitamin D, as well as thiazide diuretics and cardiac glycosides. Treatment: gastric lavage, replacement of fluid loss, use of loop diuretics (for example, furosemide), glucocorticosteroids, calcitonin, bisphosphonates. It is necessary to monitor the content of electrolytes in the blood plasma, renal 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. Metabolic disorders: rarely – hypercalcemia and hypercalciuria. Other: allergic reactions.
Storage conditions
Do not use after the expiration date stated on the packaging. Store in a place protected from moisture and light at a temperature of 15°C to 25°C. Keep out of the reach of children.
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