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Composition

active ingredients:


1 film-coated tablet contains calcium citrate Malate equivalent to calcium 250 mg, magnesium hydroxide equivalent to magnesium 100 mg, zinc sulfate equivalent to Zinc 4 mg, vitamin D3 (stabilized 20 IU/mg) 200 IU;


excipients:


croscarmellose, crospovidone, povidone K-30, corn starch, microcrystalline cellulose, colloidal anhydrous Silicon Dioxide, Magnesium Stearate, purified water, colorcoat fc4s-a, white coating (titanium dioxide (E171)), isopropyl alcohol, dichloromethane.


Dosage form

Film-coated tablets.


Basic physical and chemical properties: White to almost white capsule-shaped tablets, coated, with a fault line on one side and smooth on the other.


Pharmacotherapeutic group

Mineral impurities. Calcium in combination with vitamin D3 and/or other medications.


ATX code A12A X.


Pharmacological properties

Pharmacodynamics.


Calcium-M is a combination drug that contains active ingredients: calcium citrate Malate, vitamin D3, magnesium hydroxide and zinc sulfate. The active ingredients of the drug calcium-m normalize the exchange of calcium and phosphorus in the body, which are mainly contained in bone tissue. The drug is used for the prevention and treatment of calcium deficiency conditions. Calcium citrate is a calcium salt that is better absorbed in the gut than the most common natural form of calcium, i.e. calcium carbonate. Vitamin D3 is a fat-soluble sterol that is essential for regulating calcium-phosphorus homeostasis and bone mineralization. Vitamin D3 regulates calcium absorption and excretion, especially when calcium intake is low.


Low calcium levels cause an increase in parathyroid hormone (PTH). PTH causes the release of calcium from the bones and, consequently, an increase in the level of calcium in the blood.


Vitamin D3 is modified to be the active metabolite of calcitriol. Calcitriol increases the absorption of calcium in the small intestine, and this result affects an increase in blood calcium levels and a decrease in PTH levels. The human body needs magnesium to absorb calcium. In addition to increasing the body's ability to absorb calcium, magnesium helps strengthen bones,


making them more flexible and therefore less prone to fractures. It also leads to undesirable effects (bloating and constipation) of certain types of calcium salts.


Zinc has a stimulating effect on bone formation and mineralization, it directly activates aminoacyl-tRNA synthetase in osteoblast cells, which stimulates cellular protein synthesis. In addition, zinc inhibits osteoclastic bone resorption by inhibiting osteoclasts. Zinc can affect the process of bone resorption. Zinc plays an important role in maintaining bone mass.


Pharmacokinetics.


Suction.


Calcium. When taken orally, about 30% of calcium is absorbed due to active transport and passive diffusion in the small intestine. 99% of calcium is concentrated in the solid structures of the body (bones, teeth); 1% remains in the internal and extracellular environment. Approximately 50% of the calcium in the blood is in a physiologically active ionized form. Almost 10% is found in a complex with citrates, phosphates and other anions, the remaining 40% is part of proteins, mainly albumins.


Vitamin D3. It is well absorbed in the gastrointestinal tract in the presence of bile.


Zinc. When taken orally, 20-30% of the zinc that enters the body is absorbed.


Magnesium. Only 30-40% of magnesium is usually absorbed in the small intestine.


Distribution.


Calcium. It is mainly distributed in bone tissue and breast milk. It also crosses the placenta.


Vitamin D3. Vitamin D3 and its metabolites bind to the vitamin D-binding protein and spread in the blood. Vitamin D3 can be stored in fat and muscle tissue for a long time.


Zinc. Zinc is widely distributed, but is concentrated in muscles, bones, skin, and prostate fluid.


Magnesium. In the body, magnesium is distributed mainly in the intracellular space (within 99%): approximately 2/3 is distributed in bone tissue, and a third is located in smooth and striated muscle tissue.


Metabolism.


Vitamin D3. It is oxidized in the liver to form 25-hydroxycholecalciferol, then oxidized in the kidneys to form the active metabolites 1,25-dihydroxycholecalciferol.


Output.


Calcium salts. Unabsorbed calcium is mainly excreted in the faeces. Excess calcium is excreted in the urine.


Vitamin D3. Vitamin D3 and its metabolites are mainly excreted in the bile and feces.


Zinc. First of all, it is excreted in the faeces (about 90%); in small amounts − in the urine, about 2% − through the sweat glands.


Magnesium. The main organ for removing magnesium from the body is the kidneys, but they are also involved in storing magnesium in the body by reabsorbing the main amount in the proximal tubules (in the thick ascending segment of the Henle loop).


Indications

Calci-M is prescribed in the following cases::


calcium and vitamin D3 deficiency associated with insufficient intake of these substances from food, or in conditions that require additional administration of them;

increased need for calcium and cholecalciferol in the body during pregnancy;

prevention of osteoporosis and as an adjunct to specific therapy for osteoporosis.

Contraindications

Hypersensitivity to active substances or other components of the drug;

severe renal failure (glomerular filtration rate 30 mL / min/1.73 m2);

diseases and / or conditions associated with hypercalcemia and / or hypercalciuria;

urolithiasis (nephrolithiasis);

tuberculosis in the active phase;

vitamin D3 hypervitaminosis;

hypermagnesemia;

decalcifying tumors, such as myeloma, bone metastases, and sarcoidosis.

Interactions with other drugs and other types of interactions

Calcium and magnesium. Calcium and magnesium reduce the absorption of tetracycline, fluoroquinolones, and oral biphosphates. The interval between taking the drug calci-M and tetracycline drugs should be at least 3 hours.Corticosteroids can reduce the level of calcium absorption. There is an increased risk of hypercalcemia and metabolic alkalosis due to interaction with thiazide diuretics and hyperkalemia due to interaction with paricalcitol. High levels of calcium in the blood can increase the effect of cardiac glycosides. The effectiveness of erlotinib when used concomitantly with calcium decreases. To prevent a decrease in the absorption of bisphosphonates or sodium fluoride, it is recommended to take calcium-m no earlier than 2 hours after taking them. Concomitant administration of medications containing ion-exchange resins, such as Cholestyramine or laxatives, such as paraffin oil, may cause a decrease in the gastrointestinal absorption of vitamin D3.Vitamin D3. Enzyme-inducing antiepileptic drugs increase the metabolism of vitamin D3. The activity of vitamin D3 may decrease when it is co-administered with rifampicin, phenytoin, or barbiturates.Zinc. There is a decrease in zinc absorption when taken concomitantly with penicillins and tetracyclines.Phosphorus-containing preparations reduce the absorption of zinc. Zinc sulfate reduces the absorption of copper and fluoroquinolones, such as ciprofloxacin, levofloxacin, moxifloxacin, norfloxacin, and ofloxacin. There is a decrease in the absorption of bisphosphonates when used concomitantly with zinc. Calcium intake exceeding 2,500 mg / day may affect the absorption of other minerals, including zinc, magnesium, and phosphorus.

Application features

When using the drug calcium-m, precautions should be taken in patients with impaired calcium absorption and achlorhydria, which are often found in the elderly. During long-term treatment with the drug, it is necessary to monitor the level of calcium and creatinine in the blood serum, especially in elderly patients with concomitant therapy with cardiac glycosides or thiazide diuretics, and in patients with a high tendency to tartar formation. If signs of hypercalcemia or impaired renal function appear, the dose should be reduced or the drug should be discontinued. Precautions should be taken for pregnant women and patients with kidney stones. Toxicity monitoring should be performed in patients with impaired renal function. Precautions are necessary for patients with hypoparathyroidism, as a high dose of vitamin D3 may increase the risk of hypercalcemia and hypercalciuria. The risk of calcification of soft tissues should be taken into account. In patients with severe renal insufficiency, vitamin D3 in the form of cholecalciferol cannot be metabolized normally, so other forms of vitamin D3 should be used.


Concomitant use of high doses of vitamin D3 and/or medications or products containing calcium, magnesium, or zinc (such as milk) may cause hypermagnesemia, hypercalcemia, and milk-alkaline syndrome, followed by impaired renal function. Additional doses of the drug should be taken under the supervision of a doctor.


Eating foods containing oxalates (rhubarb, spinach) and phytin (cereals) reduces the absorption of calcium, so you should not take calcium-m Within 2 hours after eating rhubarb, spinach, cereals.


Calci-m, film-coated tablets, is recommended for use with caution in patients who have undergone colostomy, ileostomy, and patients with electrolyte imbalance. Total blood and serum cholesterol levels should be monitored to detect early signs of copper deficiency, especially if Zinc is used in high doses over a long period of time.


Use during pregnancy or lactation.


The drug can be used during pregnancy and lactation as prescribed by a doctor, if the recommended dosage is observed.


The daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D3. Pregnant women should avoid overdosing on calcium and vitamin D3, as prolonged hypercalcemia during pregnancy can lead to slower physical and mental development, stenosis and retinopathy in the child.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


There is no information about the effect of calci-m on the ability to drive vehicles or work with other automated systems. The effect of exposure is unlikely.


Dosage and administration

It is recommended to take 1-3 tablets a day for 4-6 weeks. Tablets are taken after meals, washed down with plenty of liquid. The duration of taking the drug is determined by the doctor individually.


Children.


There is no experience of using it for children.


Overdose

Symptoms of overdose may include: nausea/vomiting, loss of appetite, headache, drowsiness, weakness, fatigue, anorexia, constipation, abdominal pain, muscle weakness, mental disorders, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis, cardiac arrhythmias. Prolonged overdose with high doses of the drug can lead to irreversible kidney damage and tissue calcification.


Milk-alkaline syndrome can develop when using large doses of calcium and alkaline substances that are easily absorbed. For symptoms of milk-alkaline syndrome, see "adverse reactions".


Treatment. Symptomatic and supportive therapy. The drug should be discontinued. If thiazide diuretics and cardiac glycosides have been used, they should also be discontinued. It is necessary to empty the stomach of patients with impaired consciousness and introduce a large amount of fluid into the body. Depending on the severity of overdose, it may be necessary to use loop diuretics, bisphosphonates, calcitonin, corticosteroids separately or together. It is necessary to monitor the level of serum electrolytes, kidney function and diuresis. In severe cases, electrocardiogram (ECG) and central venous pressure (CVT) parameters should be monitored.


Side effects

Undesirable effects according to the frequency of occurrence are classified into the following categories::


infrequently (>1/1000, < 1/100), rarely (>1/10000,< 1/1000), very rarely (<1/10000), unknown (frequency not determined from available data).


From the immune system.


Unknown: hypersensitivity reactions, including angioedema, laryngeal edema.


From the side of metabolism.


Infrequently: hypercalcemia, hypercalciuria.


Very rare: lactic-alkaline syndrome (frequent urge to urinate, constant headache, constant lack of appetite, nausea or vomiting, atypical fatigue or weakness, hypercalcemia, alkalosis, kidney failure). It is observed only in case of overdose.


From the digestive tract.


Rare: constipation, dyspepsia, flatulence, nausea, abdominal pain, diarrhea.


From the skin and subcutaneous tissue.


Very rare: itching, rash, urticaria.


Other. Patients with renal insufficiency: potential risk of hyperphosphatemia, renal stone disease, and nephrocalcinosis. Magnesium can cause gastrointestinal irritation, hypermagnesemia (in patients with renal insufficiency), and a condition similar to paralytic intestinal obstruction. Prolonged use of zinc can cause copper deficiency.


In case of adverse reactions, you should consult your doctor.

Tags: Calci-M