Calcemin

Pharmacological properties

calcium is an important structural component of bone tissue. the use of calcium corrects the deficiency of calcium intake from food, especially with increased demand or reduced absorption. calcium carbonate is the salt with the highest content of elemental calcium. calcium citrate increases the bioavailability of the drug in patients with reduced acidity of the gastric contents, achlorhydria while taking blockers of h2-histamine receptors; reduces the risk of urinary tract lithiasis with long-term use, has a high antiresorptive potential due to inhibition of parathyroid hormone.

Vitamin D is very important for the absorption of calcium, phosphate and magnesium in the small intestine. It regulates the content of these elements in body fluids and helps maintain normal levels of calcium in the blood, and also takes part in the synthesis of organic elements and calcification of the skeleton.

Magnesium takes part in the metabolism of bone tissue, prevents bone demineralization, inhibits the deposition of calcium in the walls of blood vessels, heart valves, muscles, and urinary tract.

Zinc is a cofactor of more than 200 enzymes and affects the process of bone remodeling.

Copper takes part in the construction of the most important connective tissue proteins - collagen and elastin, which form the matrix of bone and cartilage.

Manganese normalizes the synthesis of glycosaminoglycans necessary for the formation of bone and cartilage. Duplicates the calcium-preserving function of vitamin D.

Boron regulates the activity of parathyroid hormone and through it the exchange of calcium, magnesium, phosphorus and cholecalciferol.

Indications

Calcemin® Advance. to reduce the rate of bone loss and correction of calcium metabolism disorders, for the treatment of diseases of the musculoskeletal system and dental diseases. It is recommended for children over 12 years of age, adults, including women in the peri- and postmenopausal period, especially if there are contraindications to the use of hormone replacement therapy. as part of a comprehensive treatment of conditions accompanied by significant loss of bone mass. as a basic tool in the use of antiresorbents (hormone replacement therapy, calcitonin, bisphosphonates) and bone formation stimulants. osteopenic conditions, systemic osteoporosis and its complications.

Calcemin^® Silver. Comprehensive treatment of osteoporosis of various origins: menopausal, senile, idiopathic, steroid, caused by prolonged immobilization, and its complications (fractures, etc.), as well as serious diseases of the teeth and periodontium. It is recommended as a basic tool for the use of antiresorbents (hormone replacement therapy, calcitonin, bisphosphonates) and bone formation stimulants. To reduce the risk of fractures with a deficiency of calcium, vitamin D, minerals in the diet in people over the age of 50.

Application

Adults and children over the age of 12 use 1 tablet with meals 1-2 times a day. drink plenty of water (200 ml). the maximum daily dose should not exceed 3 coated tablets.

The duration of treatment is determined by the doctor depending on the nature of the disease. If necessary, conduct a second course of treatment.

Contraindications

Increased individual sensitivity to any of the components of the drug (allergic reactions); hypercalcemia and / or conditions leading to hypercalcemia (sarcoidosis, malignant neoplasms and primary hyperthyroidism), severe hypercalciuria, impaired renal function, nephrolithiasis; hypervitaminosis d.

Side effects

From the digestive tract: gastrointestinal pain and abdominal pain, dyspepsia (including abdominal discomfort), constipation, diarrhea, flatulence, nausea and vomiting.

From the immune system (allergic reactions, anaphylactic reactions, anaphylactic shock). Hypersensitivity reactions, accompanied by appropriate laboratory and clinical manifestations, including asthma syndrome, mild to moderate reactions affecting the skin and / or respiratory system, gastrointestinal tract and / or cardiovascular system, have been rarely reported. Symptoms may include a rash, hives, swelling, redness, itching, and non-cardiogenic pulmonary edema. Severe reactions, including anaphylactic shock, have been very rarely reported.

On the part of laboratory indicators: with prolonged use in high doses, the development of hypercalcemia, hypercalciuria, hypervitaminosis D is possible.

special instructions

Do not exceed recommended dose. calcemin® advance and calcemin® silver should not be used simultaneously with other calcium or vitamin d preparations.

An overdose of calcium and vitamin D is accompanied by side effects, including hypercalcemia and hypercalciuria. Caution should be taken with calcium and vitamin D, so as not to exceed the total dose of calcium of 2500 mg and 4000 IU of vitamin D, taking into account food intake (see OVERDOSAGE).

Patients receiving other drugs containing vitamin D and / or calcium, or any other medicines, should consult a doctor before using this drug.

During long-term treatment with preparations containing calcium in combination with vitamin D, as well as in patients with minor or moderate renal failure (including elderly patients), it is necessary to control the level of serum calcium, phosphate and creatinine; calcium and phosphate - in the urine. If there are signs of hypercalcemia or with impaired renal function, calciuria exceeding 7.5 mmol / day (300 mg / day), the dose should be reduced or the use of the drug should be discontinued. In patients with impaired renal function and the simultaneous use of cardiac glycosides, calcium channel blockers and / or thiazide diuretics, the functional state of the kidneys should be monitored by determining the level of serum creatinine (see INTERACTIONS).

Combination drugs should be used with caution in immobilized patients because of the increased risk of hypercalcemia. For patients with impaired liver function, dose adjustment is not required. This medication should not be used in cases of impaired renal function, nephrolithiasis, or a tendency to form calcium deposits.

Use during pregnancy or lactation. During pregnancy and the period of breastfeeding, the drug is used according to the indications and under the supervision of a doctor. During pregnancy and lactation, the daily dose of Calcemin^® Advance should not exceed 2 coated tablets, Calcemin^® Silver - 1 coated tablet. The use of the drug in recommended doses is considered safe. Recommended doses should not be exceeded, since chronic overdose can be harmful to the fetus and newborn. During pregnancy and lactation, the total daily dose, taking into account the intake of food and drugs, should not exceed 2500 mg for calcium and 4000 IU for vitamin D.

In animals, against the background of an overdose of vitamin D during pregnancy, a teratogenic effect was revealed. There are no data that indicate a possible teratogenic effect in humans with the use of vitamin D in recommended doses.

Hypercalcemia in the expectant mother during pregnancy due to the intake of increased doses of vitamin D was associated with hypercalcemia in the fetus, which can lead to the development of side effects in the newborn, including inhibition of parathyroid hormone, hypocalcemia, tetany, epileptic seizures and aortic stenosis syndrome, which may be symptoms retinopathy, mental retardation or impaired growth; and also lead to the development of hypercalcemia in newborns.

Vitamin D and calcium are excreted in breast milk. This should be considered if the child is receiving any medication containing vitamin D and calcium.

To date, there is no evidence of a possible adverse effect of vitamin D and / or calcium on human fertility.

The ability to influence the reaction rate when driving vehicles or working with other mechanisms. Does not affect.

Children. Not intended for use by children under 12 years of age.

Interactions

With the simultaneous use of this drug with other medicines, you should consult your doctor.

Interaction with other drugs

Calcium can lead to a decrease in the absorption of other drugs by the formation of insoluble complexes in the digestive tract, including antibiotics (e.g. tetracycline, quinolones) and antiviral drugs, eltrombopag, sodium fluoride. In this case, calcium absorption may also decrease. To prevent potential interactions, these drugs should be used at least 2 hours before or 4-6 hours after calcium, unless otherwise indicated.

Interaction with protease inhibitors. The simultaneous use of preparations containing calcium or magnesium, including buffered drugs, leads to a decrease in the plasma concentration of all these compounds. Therefore, it is recommended to prescribe protease inhibitors 2 hours before or 1 hour after preparations containing aluminum, calcium or magnesium. Such effects have been observed with amprenavir, atazanavir, and tipranavir.

Levothyroxine should be used at least 4 hours before or 4 hours after calcium intake, since calcium reduces its absorption, possibly due to the formation of insoluble complexes.

Phosphates, bisphosphonates and fluorides. Calcium preparations reduce the absorption of bisphosphonates, so they should be used at least 30 minutes before calcium is used, but better at another time or day. Simultaneous administration of the drug with antacids containing aluminum is not recommended due to a decrease in their effectiveness.

Eltrombopag. When eating breakfast with a high fat content and calcium level (427 mg), a 59% decrease in the plasma level of Eltrombopag was revealed, while eating with a low calcium content (50 mg) there was no effect on the level of Eltrombopag in the blood plasma. Foods containing a lot of calcium and antacids with aluminum, calcium and magnesium, led to a significant decrease in systemic absorption.

Calcium and / or vitamin D. Thiazide diuretics reduce urinary calcium excretion. Due to the increased risk of hypercalcemia with the simultaneous use of thiazide diuretics, the level of calcium in the blood serum must be checked regularly.

With simultaneous use with furosemide and other loop diuretics, the excretion of calcium by the kidneys increases.

Cardiac glycosides and calcium channel blockers. Hypercalcemia increases the risk of fatal arrhythmias with cardiac glycosides, such as digoxin, and reduces the effectiveness of calcium channel blockers, such as verapamil, for atrial fibrillation. It is recommended to monitor the level of calcium in the blood serum, ECG and the clinical condition of the patient.

Glucocorticoids, hormonal contraceptives worsen the absorption of calcium ions.

Vitamin D. Some drugs may decrease the absorption of vitamin D in the digestive tract. In order to minimize interaction, it is necessary to use these drugs and vitamin D at least 2 hours before or 4-6 hours after taking vitamin D.

Such medicines are: ion-exchange resins (e.g. cholestyramine), laxatives, orlistat. Carbamazepine, phenytoin or barbiturates increase the metabolism of vitamin D to its inactive metabolites and, thus, reduce the severity of its effect.

With the simultaneous use of calcemin^® Advance / Calcemin^® Silver with vitamin A reduces the toxicity of vitamin D₃.

The interaction of calcium with food and supplements.Oxalic acid in spinach and rhubarb and phytic acid in whole grains can inhibit calcium absorption. Therefore, it is not recommended to use foods containing calcium for 2 hours after a meal with a rich content of oxalic and phytic acid.

Iron, zinc, magnesium. Calcium preparations can reduce the absorption of iron, zinc and copper from foods. For persons with sufficient reserves of iron, zinc or magnesium in the body, this does not have any clinical significance with prolonged use. For people at risk of deficiency of iron, zinc or magnesium in order to prevent inhibition of absorption of minerals from food, it is recommended to use calcium preparations at bedtime, and not with meals.

Fibers Some dietary fiber components may decrease calcium absorption. The simultaneous use of psilum with calcium does not lead to a significant decrease in calcium absorption.

Overdose

When used in recommended doses, no cases of overdose were observed. most reports of overdose are associated with the simultaneous use of high doses of single-component or multivitamin preparations. in case of accidental overdose, symptomatic treatment is recommended: gastric lavage, the use of a large amount of fluid, a diet low in calcium.

Prolonged intake of calcium and vitamin D in doses exceeding 2500 mg of calcium and 4000 IU / day of vitamin D can lead to toxic effects.

In patients with hypercalcemia or conditions associated with hypercalcemia, renal failure and / or a tendency to nephrolithiasis, toxic effects of calcium and vitamin D may occur when used in lower doses.

An acute or prolonged overdose of calcium and vitamin D can cause hypervitaminosis D, hypercalcemia, hypercalciuria, increased calcium absorption and hyperphosphatemia. The consequences are renal failure, "milk-alkaline syndrome", especially in patients with impaired renal function, calcification of blood vessels and soft tissues, including calcification, leading to nephrocalcinosis and nephrolithiasis, especially in patients with a tendency to nephrolithiasis.

Non-specific primary symptoms, such as sudden onset of headache, muscle weakness, depression of consciousness, and gastrointestinal upsets (abdominal pain, constipation, diarrhea, nausea, and vomiting) may indicate an acute overdose.

If such symptoms occur, then stop using the drug and consult a doctor.

Laboratory and clinical manifestations of poisoning and hypercalcemia may include the following symptoms: anorexia, weight loss, increased fatigue, thirst, polyuria, bone pain, heart rhythm disturbance, and impaired absorption of other minerals. Changes in laboratory data may include an increase in ALAT and AsAT in blood plasma. Chronic overdose can cause calcification of blood vessels and organs due to hypercalcemia. Extremely high hypercalcemia can lead to coma and fatal consequences.

Storage conditions

Calcemin® Advance. special storage conditions are not required. Store in a tightly closed bottle.

Calcemin^® Silver. Store at a temperature not exceeding 25 ° C in a tightly closed bottle.