Instructions for Azvestiv film-coated tablets No. 60
Composition
active ingredients: calcium, cholecalciferol;
1 tablet contains 600 mg of calcium (in the form of calcium carbonate – 1500 mg), 10 μg of cholecalciferol (vitamin D3 – 400 IU);
excipients: microcrystalline cellulose, medium chain triglycerides, sucrose, copovidone, butylhydroxytoluene (E 321), povidone, croscarmellose sodium, colloidal anhydrous silicon dioxide, magnesium stearate;
shell: Opadry® QX Green film coating mixture (copolymer of polyethylene glycol (macrogol) and polyvinyl alcohol, talc, titanium dioxide (E 171), glycerol monocaprylocaprate, polyvinyl alcohol, iron oxide yellow (E 172), iron oxide black (E 172), indigo carmine (E 132)).
Dosage form
Film-coated tablets.
Main physicochemical properties: oblong tablets with a biconvex surface, with rounded edges, covered with a green film coating.
Pharmacotherapeutic group
Calcium, combinations with vitamin D and/or other drugs. ATX code A12A X.
Pharmacological properties
Pharmacodynamics
A combined drug that regulates calcium metabolism in the body. Reduces resorption and increases bone density, replenishing the lack of calcium and vitamin D3 in the body.
Calcium ions participate in the transmission of nerve impulses, in the contraction of skeletal and smooth muscles, myocardium, in blood clotting and other physiological processes, in the formation and preservation of the integrity of bone tissue (the intercellular bone substance contains a large amount of calcium salts, which, together with the collagen protein ossein, provide hardness and elasticity).
Vitamin D3 enhances the absorption of calcium in the intestines and the reabsorption of phosphorus in the renal tubules, normalizes the formation of the skeletal skeleton and teeth in children, contributes to the preservation of bone structure. Increases the permeability of cellular and mitochondrial membranes of the intestinal epithelium, facilitating the transport of calcium ions and other divalent ions through the membranes, activates the secondary absorption of phosphates, increases the capture of these ions by bone tissue, and enhances the process of ossification.
Pharmacokinetics
Calcium
Absorption: In general, approximately 30% of the ingested calcium dose is absorbed through the gastrointestinal tract.
Distribution and biotransformation. 99% of calcium is concentrated in the hard structures of the body (bones, teeth); 1% of calcium is contained in the intracellular and extracellular environment. Approximately 50% of calcium in the blood is in a physiologically active ionized form, almost 10% is complexed with citrates, phosphates and other anions, and the remaining 40% is part of proteins, mainly albumins.
Excretion: Calcium is excreted in the feces, urine, and sweat. Renal excretion depends on the level of glomerular filtration and tubular reabsorption of calcium.
Cholecalciferol
Absorption: Vitamin D3 is readily absorbed in the small intestine.
Distribution and biotransformation. Cholecalciferol and its metabolites circulate in the blood bound to a specific globulin. In the liver, cholecalciferol is converted by hydroxylation to 25-hydroxycholecalciferol. It is then converted to the active form 1,25-dihydroxycholecalciferol in the kidneys. 1,25-dihydroxycholecalciferol is the metabolite responsible for increased calcium absorption. Unmetabolized vitamin D3 is stored in adipose and muscle tissues.
Excretion: Vitamin D3 is excreted in feces and urine.
Indication
It is used for the prevention and treatment of calcium and/or vitamin D deficiency in adult patients at identified risk.
It is used as an adjunct to specific osteoporosis therapy in patients at risk of developing calcium and vitamin D deficiency.
Contraindication
Hypersensitivity to any component of the drug; hypercalcemia (increased calcium levels in the blood), hypercalciuria (increased calcium excretion in the urine) and diseases and/or conditions leading to hypercalcemia and/or hypercalciuria (e.g. myeloma, bone metastases, primary or secondary hyperparathyroidism); hypervitaminosis D; kidney stones (nephrolithiasis, nephrocalcinosis); severe renal impairment (creatinine clearance less than 20 ml/min); children's age.
Interaction with other medicinal products and other types of interactions
Avoid taking the drug with other medications containing vitamin D3 and calcium to avoid overdose and the development of hypercalcemia.
When used simultaneously with phenytoin and barbiturates, the activity of vitamin D3 may decrease. At least 3 hours should be allowed between taking the drug and taking antacids, fluoroquinolones, penicillamine due to possible loss of effectiveness.
The activity of vitamin D3 may be reduced when used simultaneously with rifampicin.
Risk of reduced absorption of levothyroxine in the gastrointestinal tract. It is recommended to take calcium no earlier than 2 hours after taking levothyroxine.
The drug slows down the absorption of acetylsalicylic acid and other salicylates, sulfonamides, beta-blockers and indirect anticoagulants.
Corticosteroids reduce calcium absorption in the gastrointestinal tract, so the simultaneous use of such drugs may require an increase in the dosage of the drug.
To prevent reduced absorption of bisphosphonates or sodium fluoride, it is recommended to take the drug no earlier than 3 hours after taking them.
When using the drug simultaneously with cardiac glycosides, it is necessary to monitor the ECG and the patient's clinical condition, since calcium preparations may potentiate the therapeutic and toxic effects of cardiac glycosides (risk of arrhythmia).
Concomitant use of cholestyramine or laxatives based on mineral or vegetable oil may lead to reduced absorption of vitamin D3.
When used simultaneously with thiazide diuretics, the risk of developing hypercalcemia increases, since drugs of the above group reduce urinary calcium excretion.
Serum calcium levels should be monitored.
Risk of reduced absorption of ferrous salts or zinc preparations in the gastrointestinal tract. It is recommended to take calcium no earlier than 2 hours after taking these preparations.
Risk of 60–70% reduction in strontium bioavailability with concomitant use of calcium-containing drugs. It is recommended to avoid taking calcium drugs immediately before and after taking strontium-containing drugs.
Risk of reduced absorption of estramustine in the gastrointestinal tract. It is recommended to take calcium no earlier than 2 hours after taking estramustine.
Treatment with orlistat may impair vitamin D absorption.
Food. Interactions are possible with foods such as those containing oxalic acid (spinach, rhubarb, sorrel, cocoa, tea, etc.), phosphates (pork, ham, sausages, processed cheese, dessert cream, drinks containing cola, etc.) or phytic acid (cereals, dried vegetables, oilseeds, chocolate, etc.). Therefore, it is recommended to take food containing these foods some time before or after taking the drug.
Application features
Foods high in dietary fiber and fat reduce calcium absorption, so you should take breaks between eating such foods and taking the medicine (at least 2 hours).
During long-term treatment with the drug, it is necessary to control the level of calcium in the blood serum and urine and monitor renal function by measuring serum creatinine, especially in elderly patients with concomitant therapy with cardiac glycosides or thiazide diuretics and in patients with a high tendency to stone formation. If signs of hypercalcemia or impaired renal function appear, the dose should be reduced or the drug should be discontinued. It is recommended to reduce the dose or temporarily suspend treatment if urinary calcium exceeds 7.5 mmol/day (300 mg/day).
Phosphate levels should be monitored. The risk of soft tissue calcification should be taken into account.
Use with caution in patients with mild or moderate renal impairment. In case of increased serum calcium or creatinine concentrations, the dose of the drug should be reduced or treatment temporarily discontinued.
In patients with severe renal failure, the vitamin in the form of cholecalciferol cannot be metabolized normally, so other forms of vitamin D should be used.
To avoid overdose, it is necessary to take into account the intake of calcium and vitamin D3 from other sources within the recommended daily intake of calcium and vitamin D3.
It is undesirable to use the drug simultaneously with other drugs containing calcium and vitamin D3. The dose of vitamin D3 (400 IU) in 1 tablet and any other prescription of vitamin D should be taken into account. Additional doses of calcium or vitamin D should be taken under the close supervision of a doctor. In such cases, it is necessary to frequently monitor serum calcium levels and urinary calcium excretion. Milk-alkali syndrome (Burnett syndrome), i.e. hypercalcemia, alkalosis and impaired renal function, may develop when large amounts of calcium are consumed together with absorbed alkaline substances.
The drug should be used with caution in immobilized patients with osteoporosis due to the risk of developing hypercalcemia. 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.
The drug should be used with caution in patients with sarcoidosis due to the risk of increased metabolism of vitamin D3 into its active form. It is necessary to monitor the level of calcium in the blood serum and urine.
This medicinal product contains sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Ability to influence reaction speed when driving vehicles or other mechanisms
When using the drug in recommended doses, no negative effects are observed.
Use during pregnancy or breastfeeding
Pregnancy: This medicine can be used during pregnancy in case of calcium and/or vitamin D3 deficiency. However, the daily intake should not exceed 1500 mg of calcium and 600 IU of vitamin D3.
During pregnancy, overdose of cholecalciferol should be avoided. Overdose of vitamin D during pregnancy has been shown to cause teratogenic effects in animals. Pregnant women should avoid overdose of 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 cases of births of children without pathologies in mothers who received very high doses of vitamin D for hypoparathyroidism. There is no evidence that vitamin D3 in recommended doses can cause teratogenic effects in humans.
Breastfeeding: This medicine can be used during breast-feeding.
Calcium and vitamin D pass into breast milk, so it is necessary to consider additional intake of calcium and vitamin D3 from other sources for the mother and child.
Fertility: There is no information on the harmful effects of endogenous calcium and vitamin D levels within the normal range on fertility. There are no data on the effect of the drug on fertility.
Method of administration and doses
The medicine is intended for oral use. It is recommended to take the tablet within one and a half hours after a meal, without chewing and with a glass of water or juice.
Adults and elderly patients: 1 tablet twice daily (e.g. 1 tablet in the morning and 1 tablet in the evening). If necessary, a dose reduction should be considered based on calcium monitoring, as indicated in the sections “Interaction with other medicinal products and other forms of interaction” and “Special warnings and precautions for use”.
Patients with impaired liver function: no dose adjustment is required.
Patients with renal impairment: This medicinal product should not be used in patients with severe renal impairment (see section “Contraindications”).
The duration of treatment depends on the severity and course of the disease and is determined by the doctor individually.
Children
The medicine should not be used in children.
Overdose
Symptoms: In case of overdose, hypercalcemia, hypercalciuria and symptoms caused by them may be observed, namely: anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, increased fatigue, mental disorders, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis, cardiac arrhythmias in severe cases. Severe form of hypercalcemia can lead to coma and death.
Persistently high levels of calcium in the body can lead to irreversible kidney damage and soft tissue calcification.
Patients who take large amounts of calcium and absorbable alkalis may develop milk-alkali syndrome (food-induced hypercalcemia syndrome). Symptoms include frequent urination, persistent headache, persistent loss of appetite, nausea or vomiting, unusual fatigue or weakness, hypercalcemia, alkalosis, and impaired renal function. Such patients require hospitalization.
Treatment. The drug should be discontinued, the stomach should be washed, and large amounts of alkaline fluids should be administered. Thiazide diuretics, lithium, vitamin A, and cardiac glycosides should also be discontinued. Gastric lavage should be performed in patients with impaired consciousness. Rehydration should be recommended and, depending on the severity, treatment with loop diuretics, bisphosphonates, calcitonin, and corticosteroids should be administered. Serum electrolytes, renal function, and urine output should be monitored. In severe cases, ECG and calcium levels should be monitored. A low-calcium diet should be continued.
Adverse reactions
Adverse effects are classified by frequency as follows: uncommon (> 1/1000, < 1/100), rare (> 1/10000, < 1/1000), very rare (< 1/10000), frequency unknown (cannot be determined from the available data).
Immune system disorders: frequency unknown - hypersensitivity reactions, including angioedema, laryngeal edema.
Metabolic: infrequently - hypercalcemia, hypercalciuria; very rarely - milk-alkali syndrome (frequent urge to urinate, constant headache, constant lack of appetite, nausea or vomiting, unusual fatigue or weakness, hypercalcemia, alkalosis, renal failure) - only in case of overdose (see section "Overdose").
Gastrointestinal: rarely - constipation, flatulence, nausea, abdominal pain, diarrhea, dyspepsia; infrequently - tooth damage.
Skin and subcutaneous tissue disorders: very rarely - itching, rash, urticaria.
Patients with renal insufficiency: possible development of hyperphosphatemia, nephrolithiasis and nephrocalcinosis.
With prolonged use of the drug in therapeutic doses, the level of calcium in the urine and the concentration of calcium in the blood serum may increase.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 6 blisters in a pack.
Vacation category
Without a prescription.
Producer
JSC "KYIV VITAMIN FACTORY".
Location of the manufacturer and its business address
04073, Ukraine, Kyiv, Kopylivska St., 38.
