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Composition:


active ingredients: calcium carbonate, colecalciferol (vitamin D3);


1 chewable tablet contains: calcium carbonate 1250 MG, which corresponds to 500 mg of calcium, colecalciferol (vitamin D3*) 400 IU in the form of colecalciferol concentrate (in Powder Form) 4 mg;


* vitamin D3 composition: colecalciferol, alpha-tocopherol, gelatin, sucrose, corn starch, partially hydrogenated soybean oil;


excipients: xylitol, sorbitol (e 420), povidone, magnesium stearate, lemon flavor.


Dosage form. Chewable tablets.


Basic physical and chemical properties: square tablets from white to gray-white color.


Pharmacotherapeutic group. Calcium supplements. Calcium in combination with other medications. ATX code A12A X.


Pharmacological properties.


Pharmacodynamics.


The drug Calceos is a combined drug that actively affects the metabolism of calcium in the body, corrects the lack of calcium and vitamin D3 coming from food. Calceos reduces resorption and increases bone density in the body.


In the elderly, the daily requirement for calcium is 1500 mg and 500-1000 IU of vitamin D3.


Calcium is involved in the formation of bone tissue, mineralization of teeth, blood clotting processes, regulation of nerve conduction and muscle contractions, maintaining stable activity of the nervous system; it is a component of the blood coagulation system.


Colecalciferol (vitamin D3) increases the absorption of calcium in the intestine and its binding in bone tissue, regulates the exchange of calcium and phosphorus in the body.


Pharmacokinetics.


Pharmacokinetics are due to the interaction of the drug components.


Almost 30% of the calcium dose taken is absorbed in the gastrointestinal tract. Calcium is absorbed in ionized form in the proximal small intestine by an active D-vitamin-dependent transport mechanism. At least 99% of calcium is concentrated in dense structures of the body (bones, teeth), 1% - in the external and intracellular space.


Almost 50% of the calcium in the blood is in a physiologically active ionized form. Almost 10% — in combination with citrates, phosphates and other anions. The remaining 40% are part of proteins, mainly albumins.


Calcium is excreted in the feces, urine, and sweat.


Vitamin D3 is easily absorbed in the small intestine. Colecalciferol and its metabolites circulate in the blood as specific globulins. Vitamin D3, in order to become active, undergoes double hydroxylation: first in the liver, colecalciferol is converted to the hydroxyl-active form of 25 — hydroxycolecalciferol, then in the kidneys-to 1,25-hydroxycolecalciferol, which is responsible for increased absorption of calcium. Vitamin D3 that has not been metabolized is stored in muscle and adipose tissue. Vitamin D3 is excreted in the feces and urine.


Clinical characteristics.


Indications.


It is used for the prevention and treatment of calcium and/or vitamin D3 deficiency in adults; for the prevention and complex therapy of osteoporosis.


Contraindications.


- Hypersensitivity to active substances or to any of the excipients.


- The preparation contains partially hydrogenated soybean oil. Patients who are allergic to peanuts or soy should not take this medicine.


- Hypercalcemia (increased blood calcium levels), hypercalciuria (increased urinary calcium excretion), and diseases and/or conditions leading to hypercalcemia and/or hypercalciuria (e.g. myeloma, bone metastases, primary or secondary hyperparathyroidism).


- Kidney stones (nephrolithiasis, nephrocalcinosis).


- Hypervitaminosis D.


- Renal failure (creatinine clearance less than 20 mL/min.).


- In the case of prolonged immobilization of patients, which is accompanied by hypercalciuria and/or hypercalcemia, treatment with the drug is possible after the patient's mobility is restored.


Interactions with other drugs and other types of interactions.


Combinations that require caution when using:


Digitalis(digitalis)


Risk of arrhythmia. Oral administration of calcium in combination with vitamin D increases the toxicity of digitalis. Strict medical supervision is required and, if necessary, monitoring of electrocardiogram parameters and blood calcium levels.


Bisphosphonates


Risk of reduced absorption of bisphosphonates in the gastrointestinal tract. It is recommended to take the calcium preparation no earlier than 2 hours after taking bisphosphonates.


Thiazide diuretics


Reduced urinary calcium excretion. Monitoring of blood calcium levels is recommended.


Oral tetracycline antibiotics


It is possible to reduce the absorption of tetracycline. It is recommended to postpone calcium intake for at least three hours.


In the case of additional intake of high doses of vitamin D, weekly monitoring of serum and urine calcium levels is extremely necessary.


Divalent iron salts and zinc preparations


Risk of reduced absorption of divalent iron salts or zinc preparations in the gastrointestinal tract. It is recommended to take calcium no earlier than 2 hours after taking these medications.


Strontium


Risk of reducing the bioavailability of Strontium by 60-70% with simultaneous use of calcium-containing drugs. It is recommended to avoid taking calcium supplements immediately before and after taking strontium-containing medications.


Estramustine


Risk of reduced absorption of Estramustine in the gastrointestinal tract. It is recommended to take calcium no earlier than 2 hours after taking Estramustine.


Thyroid hormones


Risk of reduced absorption of Levothyroxine in the gastrointestinal tract. It is recommended to take calcium no earlier than 2 hours after taking levothyroxine.


Orlistat


Treatment with orlistat can potentially impair the absorption of vitamin D.


Food products


Possible interaction with food products, such as those containing oxalic acid (spinach, rhubarb, sorrel, Cocoa, Tea, etc.), phosphates (pork, ham, sausages, processed cheese, dessert cream, Cola-containing beverages, etc.) or phytic acid (cereals, dry vegetables, oilseeds, chocolate, etc.). Therefore, it is recommended to take food containing these products some time before or after taking the drug.

Application features.


- In case of prolonged immobilization of patients with hypercalciuria and/or hypercalcemia, treatment with calcium and vitamin D is possible only after the patient's mobility is restored.


- With long-term treatment, it is advisable to monitor the level of calcium in the blood serum and urine, as well as kidney function (serum creatinine level). It is recommended to temporarily reduce the dose or discontinue treatment if urinary calcium excretion exceeds 7.5 mmol/24 h (300 mg/24 h). Such monitoring is especially important for elderly patients, in the case of concomitant treatment with cardiac glycosides or diuretics, and for patients prone to kidney stones. In the presence of hypercalcemia or signs of impaired renal function, the dose of the drug should be reduced or treatment should be interrupted.


- In the case of simultaneous treatment with digitalis preparations, bisphosphonates, thiazide diuretics, tetracyclines, consider the possibility of their interaction with Calceos (see the section "interaction with other drugs and other types of interactions").


- You should take into account the dose of vitamin D (400 IU) in 1 tablet and any other prescription of vitamin D. Additional intake of vitamin D or calcium supplements should be carried out under strict medical supervision. In such a situation, weekly monitoring of serum and urine calcium levels is definitely necessary.


- The drug should be prescribed with caution to patients with sarcoidosis due to the possible increase in the metabolism of vitamin D in its active form. These patients should be monitored for Serum and urine calcium levels.


- The drug should be used with caution in patients with renal insufficiency, and its effect on calcium and phosphate homeostasis should also be monitored. The risk of soft tissue calcification should be considered. In patients with severe renal insufficiency, vitamin D3 in the form of colecalciferol is not metabolized normally, so other forms of vitamin D3 should be used.


- The drug contains sorbitol, so it should not be used in patients with rare hereditary diseases associated with fructose intolerance.


- Since the drug contains sucrose, it should not be used in patients with rare hereditary diseases associated with fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency.


- The drug is not intended for use in children.


Use during pregnancy or lactation.


This medicine can be used during pregnancy or lactation. However, the daily intake should not exceed 1500 mg of calcium and 600 IU of vitamin D3.


Overdose with colecalciferol should be avoided during pregnancy:


- vitamin D overdose during pregnancy has been shown to cause teratogenic effects in animals;


- pregnant women should be prevented from overdosing on vitamin D, as long-term hypercalcemia can lead to physical and mental retardation, supravalvular aortic stenosis and retinopathy in the child. However, there are several reports of children born without pathologies whose mothers received very high doses of vitamin D for hypoparathyroidism.


Vitamin D and its metabolites pass into breast milk. This should be taken into account when prescribing additional vitamin D supplements to your child.


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


It doesn't affect you.


Dosage and administration.


The drug is intended for use only in adults.


For internal use.


Take 1 tablet 2 times a day. Tablets should be chewed or dissolved.


Children.


The drug is not intended for use in children.


Overdose.


Overdose of the drug can lead to hypervitaminosis and hypercalcemia. Symptoms of hypercalcemia may include: anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disorders, polydipsia, polyuria, bone pain, kidney calcification, kidney stones, and in severe cases, cardiac arrhythmia. Excessive hypercalcemia can lead to coma and death. Long-term high calcium levels can lead to permanent kidney damage and soft tissue calcification.


Treatment of hypercalcemia: the use of calcium and vitamin D3 should be discontinued. Treatment with thiazide diuretics, lithium, vitamin A, and cardiac glycosides should also be discontinued. In patients with impaired consciousness, gastric lavage should be performed. Rehydration and, depending on the severity, treatment with loop diuretics, bisphosphonates, calcitonin, and corticosteroids should be recommended. Serum electrolyte levels, renal function, and diuresis should be monitored. In severe cases, ECG and calcemia should be monitored.


Adverse reactions.


Adverse reactions are listed below, distributed by frequency of occurrence. Frequency is defined as: infrequent (>1/1000, 1/10, 000,


Disorders of the immune system.


Cases of allergic reactions, such as angioedema or laryngeal edema, have been reported.


Metabolic and nutritional disorders.


Rare: hypercalcemia and hypercalciuria.


Disorders of the gastrointestinal tract.


Infrequent: tooth damage.


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


From the skin and subcutaneous tissue.


Rare: pruritus, rash, and hives.

Tags: Calcium, Colecalciferol