Calcium, Cholecalciferol

Pharmacological properties

Vitamin D3 increases the absorption of calcium in the intestines. the use of calcium and vitamin d3 prevents the increase in the level of parathyroid hormone (ptg), which is caused by a deficiency of calcium and leads to increased / increased bone resorption (leaching of calcium from bones).

A clinical study in hospitalized patients with vitamin D deficiency showed that daily intake of 2 tablets of calcium 500 mg and vitamin D at a dose of 400 IU for 6 months normalized the level of 25-hydroxylated metabolite of vitamin D₃ and reduced the manifestations of secondary hyperparathyroidism and the level of alkaline phosphatase.

Pharmacokinetics Calcium. Suction. About 30% of the accepted dose of calcium is absorbed in the digestive tract.

Distribution and biotransformation. 99% of calcium is concentrated in the solid structures of the body (bones, teeth); 1% remains in the internal and extracellular environment. About 50% of the calcium in the blood is contained in a physiologically active ionized form. Almost 10% is in complex with citrates, phosphates and other anions, the remaining 40% are part of proteins, mainly albumin.

Calcium is excreted in feces, urine and sweat. Excretion by the kidneys depends on glomerular filtration and tubular reabsorption of calcium.

Cholecalciferol. Suction. Vitamin D₃ easily absorbed in the small intestine.

Distribution and biotransformation. Cholecalciferol and its metabolites circulate in the blood in a bound state with specific globulin. Cholecalciferol in the liver is converted by hydroxylation to 25-hydroxycholecalciferol, then in the kidneys to the active form 1,25-dihydroxycholecalciferol, which is a metabolite responsible for enhanced absorption of calcium. Vitamin D₃, which has not undergone metabolism, is stored in muscle and adipose tissues.

Vitamin D₃ excreted in feces and urine.

Indications

Calcium D3 Nycomed with orange / mint flavor

Prevention and treatment of calcium and vitamin D deficiency

The additional use of vitamin D and calcium as an addition to the specific treatment of osteoporosis in patients at risk of developing calcium and vitamin D deficiency

Calcium D₃ Nycomed Forte.

Prevention and treatment of calcium and vitamin D deficiency in elderly patients.

The additional use of vitamin D and calcium as an addition to the specific treatment of osteoporosis in patients at risk of developing calcium and vitamin D deficiency

Calcium D₃ Nycomed Osteoforte

Prevention and treatment of calcium and vitamin D deficiency in elderly patients.

The additional use of vitamin D and calcium as an addition to the specific treatment of osteoporosis in patients at risk of developing calcium and vitamin D deficiency

Application

The drug is intended for oral use. chew or dissolve the tablet.

Calcium D₃ Nycomed with orange / mint flavor

Calcium and Vitamin D Deficiency

Adults: 1 tablet 1-3 times a day.

Children over the age of 5 years: 1 tablet 1-2 times a day as recommended by a doctor.

Supplement to Osteoporosis Therapy

Adults: 1 tablet 2-3 times a day.

For patients with liver failure, dose adjustment is not required.

In patients with severe renal failure, the drug should not be used (see CONTRAINDICATIONS).

Elderly patients. It is recommended to use the same doses as in adults.

Calcium D₃ Nycomed Forte. Adults and elderly patients: 1 tablet 2 times a day.

Calcium D₃ Nycomed Osteoforte. Adults and elderly patients: 1 tablet 1 time per day.

Patients with liver failure: dose adjustment is not required.

Patients with severe renal failure should not use the drug (see CONTRAINDICATIONS).

Contraindications

• Hypersensitivity to the active substance or other components of the drug; severe renal failure (glomerular filtration rate of 30 ml / min / 1.73 m2); diseases and / or conditions associated with hypercalcemia and / or hypercalciuria; nephrolithiasis (urolithiasis); hypervitaminosis d; calcium-d3 nycomed with an orange / mint flavor - tuberculosis in the active phase.

Side effects

Undesirable effects by frequency of occurrence are classified as follows: infrequently (≥1 / 1000, 1/100), rarely (≥1 / 10,000, 1/1000), very rarely (1/10 000), unknown (frequency not determined by available data).

From the immune system: unknown - hypersensitivity reactions, including angioedema, laryngeal edema.

From the side of metabolism: infrequently - hypercalcemia, hypercalciuria.

Very rarely, milk-alkaline syndrome (frequent urination, constant headache, constant lack of appetite, nausea or vomiting, atypical fatigue or weakness, hypercalcemia, alkalosis, renal failure). Occur only in case of overdose (see OVERDOSAGE).

From the digestive system: rarely - constipation, dyspepsia, flatulence, nausea, abdominal pain, diarrhea.

On the part of the skin and subcutaneous tissue: very rarely - itching, rash, urticaria.

Patients with renal failure. Perhaps the development of hyperphosphatemia, nephrolithiasis and nephrocalcinosis (see SPECIAL INSTRUCTIONS).

special instructions

During prolonged treatment with the drug, it is necessary to control the level of calcium, serum creatinine and kidney function, especially in the elderly with combined therapy with cardiac glycosides or diuretics (see interactions) and in patients with a high tendency to calculus formation. in case of signs of hypercalcemia or impaired renal function, it is necessary to reduce the dose or stop taking the drug.

The drug should be used with caution in patients with hypercalcemia or signs of impaired renal function and control the level of calcium and phosphates. The risk of soft tissue calcification should be taken into account. In patients with severe renal insufficiency, vitamin D in the form of cholecalciferol cannot be metabolized normally, so other forms of vitamin D should be used (see CONTRAINDICATIONS).

The simultaneous intake of vitamin D from other sources, in particular from medicines or products containing calcium (e.g. milk), can lead to hypercalcemia and milk-alkaline syndrome, followed by impaired renal function. In order to avoid overdose while prescribing other preparations containing vitamin D, it is necessary to take into account the content of vitamin D in the preparation Calcium-D₃ Nycomed Osteoforte (800 IU). Additional doses of calcium or vitamin D should be taken under medical supervision. In such patients, it is necessary to regularly monitor the level of calcium in the blood plasma and renal function.

Calcium D₃ Nycomed with orange / mint flavor is contraindicated in patients with sarcoidosis and hypoparathyroidism because of the risk of increasing vitamin D metabolism₃ into its active form. It is necessary to monitor the level of calcium in the blood serum and urine in such patients.

Calcium D₃ Nycomed Forte and Calcium-D₃ Nycomed Osteoforte should be used with caution in patients with sarcoidosis due to the risk of increased vitamin D metabolism₃ into its active form. It is necessary to control the level of calcium in blood serum and urine.

Calcium D₃ Nycomed is used with caution in immobilized patients with osteoporosis due to the risk of hypercalcemia.

Patients with rare hereditary fructose intolerance, sucrose-isomaltase deficiency or malabsorption of glucose-galactose should not use the drug, since it contains isomalt and sucrose.

During pregnancy and breastfeeding. Pregnancy. Calcium D₃ Nycomed can be used during pregnancy with a deficiency of calcium and vitamin D. The daily dose should not exceed 2500 mg of calcium and 4000 IU of vitamin D. Animal studies have shown that vitamin D in high doses has reproductive toxicity. Pregnant women should avoid an overdose of Calcium-D₃ Nycomed, since prolonged hypercalcemia causes adverse effects on the fetus. There is no evidence that vitamin D at recommended doses can cause a teratogenic effect in humans.

Lactation. Calcium D₃ Nycomed can be used during lactation. Calcium Vitamin D₃ and its metabolites can pass into breast milk, so you need to consider the intake of calcium and vitamin D from other sources in the baby’s body.

Children. The drug is used to treat calcium and vitamin D deficiency.₃ in children over the age of 5 years on the recommendation of a doctor. Calcium D₃ Nycomed Forte and Calcium-D₃ Nycomed Osteoforte is not intended for use in children and adolescents.

The ability to influence the reaction rate when driving vehicles and working with other mechanisms. There is no data on the effect of the drug on the reaction rate when driving vehicles or other mechanisms.

Interactions

The activity of vitamin d3 may decrease with its simultaneous use with rifampicin.

Thiazide diuretics reduce urinary calcium excretion. With combined therapy, it is necessary to control the level of calcium in the blood serum, since the risk of hypercalcemia increases.

Calcium carbonate may interfere with the absorption of tetracycline drugs. Tetracycline drugs should be taken 2 hours before or 4-6 hours after taking Calcium-D₃ Nycomed.

Hypercalcemia can potentiate the toxicity of cardiac glycosides (possible occurrence of arrhythmias, etc.) with the use of calcium and vitamin D.

Calcium D₃ Nycomed with orange / mint flavor. The simultaneous use in patients taking cardiac glycosides and high doses of calcium is not recommended. If necessary, combined therapy with cardiac glycosides is necessary to use the drug in low doses, to monitor the ECG and calcium levels in blood plasma.

Calcium D₃ Nycomed Forte and Calcium-D₃ Nycomed Osteoforte. It is necessary to monitor the work of the heart using an ECG, the level of calcium in the blood serum and the clinical condition of the patient.

To prevent a decrease in the absorption of bisphosphonates, it is recommended to take Calcium-D₃ Nycomed no earlier than 1 hour after their administration.

With the simultaneous use of calcium, the effectiveness of levothyroxine can be reduced by reducing its absorption. Levothyroxine must be taken 4 hours after taking Calcium-D₃ Nycomed.

With the simultaneous use of calcium, the absorption of quinolone antibiotics may be impaired. Quinolone antibiotics should be taken 2 hours before or 6 hours after taking Calcium-D₃ Nycomed.

Calcium salts can reduce the absorption of iron, zinc and strontium ranelate. Therefore, iron, zinc and strontium ranelate preparations must be taken 2 hours before or after taking Calcium-D₃ Nycomed.

Orlistat treatment could potentially interfere with the absorption of fat-soluble vitamins (e.g. vitamin D₃).

Overdose

Symptoms an overdose can lead to hypercalcemia and hypervitaminosis d. Symptoms of hypercalcemia are anorexia, thirst, nausea, vomiting, constipation, abdominal pain, muscle weakness, fatigue, mental disorders, polydipsia, polyuria, bone pain, nephrocalcinosis, nephrolithiasis, heart rhythm disturbances in severe cases. severe hypercalcemia can lead to coma and death.prolonged overdose of high doses of the drug can lead to irreversible damage to the kidneys and tissue calcification.

Milk-alkaline syndrome can develop with the use of calcium in high doses and easily digestible alkaline substances. For symptoms of milk-alkaline syndrome, see ADVERSE EFFECTS.

Treatment. Symptomatic and supportive therapy. You should stop using the drug. In the case of previous therapy with thiazide diuretics and cardiac glycosides, they must also be canceled.

It is necessary to flush the stomach of patients with impaired consciousness and introduce a large amount of fluid into the body. Depending on the severity of the overdose, it may be necessary to use loop diuretics, bisphosphonates, calcitonin, corticosteroids individually or in combination. It is necessary to control the level of electrolytes in blood serum, kidney function and diuresis. In severe cases, ECG and central venous pressure should be monitored.

Storage conditions

Store the bottle tightly closed at a temperature not exceeding 30 ° C.

UA / TAK / 1218/0040