Properties
What is it?
Calcemin Silver Dosage form: Film-coated tablets Description: Oval, light gray tablets with a score on one side. Composition: Active ingredients: Calcium (calcium citrate and calcium carbonate) 500mg, Vitamin D3 400 IU, Magnesium 40mg, Zinc 7.5mg, Copper 1mg, Manganese 1.8mg, Boron 250mcg. Excipients: Microcrystalline cellulose (E460), stearic acid (E570), croscarmellose sodium, soy polysaccharide, sodium lauryl sulfate, magnesium stearate (E572). Coating: Hypromellose, magnesium silicate (E553a), titanium dioxide (E171), triacetin (E1518), mineral oil (E905), FD&C Blue No. 2 Lake (E132), FD&C Yellow No. 6 Lake (E110). Pharmacotherapeutic group: Mineral supplement. Calcium preparations in combination with other drugs. Pharmacological properties: Calcium is an important component of bone tissue. Vitamin D3 (cholecalciferol) increases calcium absorption in the small intestine, activates bone tissue remodeling processes through increased synthesis of type I collagen and osteoblasts. Improves bone quality by suppressing osteoclast activity. Calcium and vitamin D intake reduces the release of parathyroid hormone (PTH), which is caused by calcium deficiency and is one of the causes of osteoporosis development (bone resorption). Magnesium participates in bone tissue metabolism. Zinc is a cofactor for over 200 enzymes involved in protein and nucleic acid synthesis, responsible for growth and cell repair. Copper participates in the construction of essential connective tissue proteins, collagen and elastin, which form the bone and cartilage matrix. Manganese normalizes the synthesis of glycosaminoglycans, which are essential for the formation of bone and cartilage tissue. Boron regulates the activity of parathyroid hormones, which in turn affect the metabolism of calcium, magnesium, phosphorus, and vitamin D. Indications: Prevention of osteoporosis and other calcium-deficient conditions. Complex treatment of osteoporosis when calcium and vitamin D deficiency is diagnosed. Reducing the risk and complex treatment of fractures of various localizations in calcium-deficient conditions in individuals over 50 years of age. Method of administration and dosage: For adults and children over 12 years of age: 1 tablet 2 times a day, during meals. The duration of administration is determined by the doctor. If necessary, the course of treatment can be repeated. Dose adjustment is not required in patients with impaired liver function. In patients with impaired kidney function: The drug Calcemin Silver is not used in severe renal insufficiency. Elderly patients: The dose is the same as for adults. Possible decline in kidney function should be considered. Side effects: Gastrointestinal disorders: abdominal pain, dyspepsia, constipation, diarrhea, flatulence, nausea, vomiting. Immune system disorders: allergic reactions, including anaphylactic reactions, anaphylactic shock. Hypersensitivity reactions have rarely been observed, with corresponding laboratory and clinical manifestations, including asthma syndrome, mild to moderate reactions affecting the skin and/or respiratory system, gastrointestinal tract and/or cardiovascular system. Symptoms may include rash, urticaria, swelling, redness of the skin, itching, non-cardiogenic pulmonary edema. Very rarely severe reactions, including anaphylactic shock. Laboratory findings: hypercalcemia, hypercalciuria, vitamin D hypervitaminosis (with prolonged intake of high doses). Contraindications: Hypersensitivity to any component of the drug: hypercalcemia and/or conditions that cause hypercalcemia (e.g., sarcoidosis, malignant neoplasms, primary hyperparathyroidism), hypercalciuria, impaired kidney function, urolithiasis; vitamin D hypervitaminosis, children under 12 years of age. Overdose: Overdose may manifest with symptoms similar to side effects. Toxic effects may develop with doses exceeding 2500mg of calcium and 4000 IU/day of vitamin D. In patients with hypercalcemia or conditions associated with hypercalcemia, renal insufficiency and/or a tendency to nephrolithiasis, even small doses of calcium and vitamin D can cause toxic effects. Single or prolonged overdose of calcium and vitamin D can lead to vitamin D hypervitaminosis, hypercalcemia, hypocalciuria, and hyperphosphatemia. This results in renal failure, "milk-alkali syndrome", calcification of blood vessels and soft tissues, including calcinosis, leading to nephrocalcinosis and nephrolithiasis. Non-specific primary symptoms such as sudden headache, muscle weakness, clouded consciousness, and gastrointestinal irritation (abdominal pain, constipation, diarrhea, vomiting, and nausea) may indicate overdose. If such symptoms develop, discontinue the drug. Laboratory and clinical manifestations of intoxication and hypercalcemia may include anorexia, weight loss, fatigue, fever, polyuria, bone pain, muscle weakness, cardiac arrhythmias, mental disorders, polydipsia, polyuria, and impaired absorption of other minerals, increased aspartate aminotransferase and alanine aminotransferase in blood plasma. Prolonged overdose leads to hypercalcemia and may cause calcification of blood vessels and organs. Very high hypercalcemia can cause reversible kidney damage and soft tissue calcification, coma, and even death. In case of accidental overdose, symptomatic treatment is recommended: gastric lavage, increased fluid intake, low-calcium diet, rehydration, loop diuretics, bisphosphonates, calcitonin, and corticosteroids. It is necessary to monitor kidney function, diuresis, and electrolyte concentrations in the blood. In severe cases, ECG and CBC monitoring. Special instructions and precautions: To avoid exceeding the daily dose of 2500mg calcium and 4000 IU vitamin D, which can cause toxic effects, consider other sources of elements in the body (e.g., food). During treatment, it is recommended to determine calcium levels in blood and urine. Long-term therapy with combined calcium and vitamin D preparations requires monitoring of serum calcium and creatinine levels. Observation is particularly important in elderly patients taking cardiac glycosides, calcium channel blockers, and/or thiazide diuretics, as well as in patients prone to stone formation. In case of hypercalcemia, impaired kidney function, calciuria, >75 mmol/day (300mg/day), it is necessary to reduce the dose or discontinue the drug. Combined preparations are prescribed with caution in immobilized patients due to the high risk of developing hypercalcemia. The preparation contains sodium, which should be considered for patients on a sodium-controlled diet. Interactions with other drugs: Calcium preparations may reduce the absorption of other drugs (including antibiotics, e.g., tetracyclines, quinolones) and antiviral drugs, protease inhibitors, eltrombopag) from the gastrointestinal tract. In addition, calcium absorption may also be reduced. To avoid potential interactions, it is necessary to observe intervals between taking these drugs, 2 hours before or 4-6 hours after taking calcium, unless otherwise indicated. The interval between levothyroxine and calcium preparations should be 4 hours before or after administration. Fluoroquinolones 2 hours before or 6 hours after, phosphates, bisphosphonates - 1 hour before, fluorides and iron preparations - 3 hours before taking calcium. Simultaneous use with albumin-containing antacids is not recommended due to reduced efficacy. Calcium and/or vitamin D-thiazide diuretics reduce calcium excretion. Due to the increased risk, regular monitoring of serum calcium levels is necessary when used concurrently with thiazide diuretics. Furosemide and other loop diuretics, on the contrary, increase calcium excretion by the kidneys. Cardiac glycosides and calcium channel blockers: Hypercalcemia increases the risk of fatal arrhythmias caused by cardiac glycosides, such as digoxin, and reduces the activity of calcium channel blockers, such as verapamil, in atrial fibrillation. Monitoring of the patient's clinical condition, serum calcium levels, and ECG is recommended. Glucocorticoids, hormonal contraceptives worsen the absorption of calcium ions. Vitamin D. Some drugs may reduce the absorption of vitamin D in the gastrointestinal tract. To minimize interactions between vitamin D and drugs, it is necessary to observe intervals between administrations, 2 hours before and 4-6 hours after taking vitamin D. Such medications include ion-exchange resins (e.g., cholestyramine), orlistat. Carbamazepine, phenytoin, or barbiturates activate vitamin D metabolism to an inactive metabolite, reducing its effectiveness. Simultaneous use of Calcemin Silver and vitamin A reduces the toxic effect of vitamin D. Interaction of calcium with food products and dietary supplements. Oxalic acid, found in spinach and rhubarb, and phytic acid (cereals) can inhibit calcium absorption. Therefore, it is not recommended to use calcium-containing preparations within 2 hours of consuming foods containing oxalic and phytic acids. Calcium may reduce the absorption of iron, zinc, and magnesium from food, which should be considered in patients with deficiencies of these minerals. To avoid inhibition of mineral absorption from food in these patients, it is advisable to take calcium preparations before bedtime and not during meals. Pregnancy and lactation: The use of the drug is not recommended during pregnancy and lactation. Prolonged overdose is harmful to the fetus and newborn. Hypercalcemia during pregnancy is a consequence of high-dose vitamin D intake, which can cause side effects in the fetus: suppression of parathyroid hormone, hypercalcemia, tetany, epileptic seizures, and aortic stenosis syndrome, symptoms of which may include retinopathy, mental development or growth retardation, and hypercalcemia in newborns. Vitamin D and calcium are excreted in breast milk. Effect on driving and operating machinery: No effect. Storage conditions: Store at a temperature not exceeding 25°C, out of reach of children. Shelf life: 3 years. Do not use after the expiry date indicated on the packaging. Packaging: 30, 60 or 120 tablets in a bottle. The bottle, along with the leaflet, is placed in a cardboard box. Dispensing conditions: Over-the-counter. See also: Calcemin - Calcemin 30 tablets