Calcium-D3 Nicomed Strawberry-Amelon, 60 pcs.

Calcium-phosphorus metabolism regulator. ATX code: A12AX

Pharmacological properties

Pharmacodynamics

A combination drug that regulates calcium and phosphorus metabolism in the body (bones, teeth, nails, hair, muscles). It reduces resorption (resorption) and increases bone density, making up for the lack of calcium and vitamin D3 in the body. Calcium is involved in the regulation of nerve conduction, muscle contractions, hormone production and is a component of the blood clotting system.

The adequate intake of calcium is especially important during growth, pregnancy and lactation.

Vitamin D3 increases the absorption of calcium in the intestine.

The use of calcium and vitamin D3 inhibits increased production of parathyroid hormone (PTH), which is a stimulant of increased bone resorption (leaching of calcium from bones).

Pharmacokinetics

Calcium

Intake: Normally, the amount of calcium absorbed in the gastrointestinal tract is about 30% of the dose taken.

Distribution and metabolism: 99% of calcium in the body is concentrated in the hard structure of the bones and teeth. The remaining 1% is in intra- and extracellular fluids. About 50% of the total calcium content of the blood is in the physiologically active ionized form, of which about 10% is complexed with citrate, phosphate or other anions; the remaining 40% is associated with proteins, primarily with albumin.

Excretion: Calcium is excreted by the intestines, kidneys, and sweat glands. Renal excretion depends on glomerular filtration and tubular reabsorption of calcium.

Vitamin D3

Intake: Vitamin D3 is readily absorbed in the small intestine (about 80% of the dose taken).

Distribution and metabolism: Colecalciferol and its metabolites circulate in the blood associated with specific globulin. Colecalciferol is converted in the liver by hydroxylation to 25-hydroxycolecalciferol. It is then converted in the kidneys to the active form 1,25-hydroxycolecalciferol. 1,25-hydroxycalciferol is the metabolite responsible for increasing calcium absorption. Non-metabolized vitamin D3 is deposited in fat and muscle tissue.

Excretion: Vitamin D3 is excreted by the intestines and kidneys.

Indications

Prevention and treatment of calcium and/or vitamin D3 deficiency.

Add to specific therapy and prevention of osteoporosis and its complications (bone fractures).

Active ingredient

Composition

Active ingredients:

Calcium carbonate – 1250 mg (equivalent to elemental calcium – 500 mg)

Colocalciferol (vitamin D3) – 5.0 µg* (200 IU) as colocalciferol concentrate** – 2.0 mg*

Auxiliary Components:

Sorbitol – 390 mg

Strawberry and watermelon flavoring granulate*****- 10.2 mg

/p>

Povidone – 36.4 mg

Magnesium stearate – 6.00 mg

Aspartame – 1.00 mg.

*The amount of colocalciferol (vitamin D3), including 10% excess, is – 5.5 mcg, in the form of colocalciferol concentrate -2.2 mg.

**calciferol concentrate contains, including 10% excess: Colocalciferol – 0.0055 mg, alpha-tocopherol – 0.022 mg, modified corn starch – 1.607 mg, sucrose – 0.385 mg, sodium ascorbate – 0.088 mg, medium-chain triglycerides – 0.066 mg, silica dioxide – 0.026 mg.

***** strawberry- watermelon flavoring granulate contains: maltodextrin – 8.25 mg, strawberry- watermelon flavoring – 0.276 mg, triacetin – 0.163 mg, glycerol and diacetylvin and fatty acid esters – 0.0918 mg, medium-chain triglycerides – 0.0918 mg, water – 1.33 mg.

How to take, the dosage

Calcium-D3 Nycomed is taken orally.

The tablets can be chewed or crushed and taken with food.

Prevent and treat calcium and/or vitamin D3 deficiency.

Adults and children over 12 years of age take 1 tablet twice daily, or 2 tablets once daily.

Children from 5 years to 12 years – 1-2 tablets a day.

Children from 3 to 5 years of age – dosage according to the doctor’s recommendation.

Addition to specific therapy and prevention of osteoporosis and its complications (bone fractures).

Adults – 1 tablet 2-3 times a day.

Patient special groups

Patients with impaired liver function:

Dose adjustment is not required.

Patients with impaired renal function:

Calcium-D3 Nicomed should not be used in severe renal failure.

Elderly patients:

The dose is the same as for adults. Possible decreased creatinine clearance should be considered.

The duration of treatment

When used for the prevention and treatment of calcium and/or vitamin D3 deficiency, the average duration of the course of treatment is at least 4-6 weeks. The number of repeated courses within a year is determined individually.

When used to supplement specific therapy and to prevent osteoporosis and its complications (bone fractures) the duration of treatment is determined by the doctor individually.

Interaction

Hypercalcemia may potentiate toxic effects of cardiac glycosides when used simultaneously with calcium and vitamin D preparations. Control of ECG and serum calcium is necessary.

Calcium preparations may decrease absorption of tetracyclines from the gastrointestinal tract. Therefore, tetracycline-type drugs should be taken at least 2 hours before or 4-6 hours after taking Calcium-D3 Nicomed.

To prevent loss of absorption of bisphosphonates, they should be taken at least one hour before taking Calcium-D3 Nycomed.

Glucocorticosteroids decrease calcium absorption, so treatment with glucocorticosteroids may require increasing the dose of Calcium-D3 Nycomed.

The simultaneous use of thiazide-type diuretics increases the risk of hypercalcemia because they increase the channel reabsorption of calcium. When concomitant use of thiazide diuretics the serum calcium content should be monitored regularly.

Calcium decreases the effectiveness of levothyroxine by reducing its absorption. The time period between taking levothyroxine and Calcium-D3 Nicomed should be at least 4 hours.

Absorption of quinolone antibiotics is reduced when used simultaneously with calcium preparations. Therefore, antibiotics of quinolone group should be taken 2 hours before or 6 hours after taking Calcium-D3 Nicomed.

Calcium salts may reduce absorption of iron, zinc and strontium ranelate. Therefore, preparations of iron, zinc or strontium ranelate should be taken at least two hours before or two hours after taking Calcium-D3 Nycomed.

Treatment with orlistat may potentially interfere with absorption of fat-soluble vitamins (e.g., vitamin D3).

Special Instructions

Serum calcium and creatinine should be monitored during long-term therapy. Monitoring is especially important in elderly patients with concomitant treatment with cardiac glycosides and diuretics (see section “Interaction with other medicinal products and foodstuffs”) and in patients with increased propensity to form kidney stones. In cases of hypercalcemia or signs of impaired renal function, the dose should be reduced or the treatment discontinued.

Vitamin D3 should be used with caution in patients with renal insufficiency. In this case it is necessary to control the content of calcium and phosphate in serum. Risk of soft tissue calcinosis should also be considered.

In order to avoid overdose, additional vitamin D and calcium intake from other sources must be considered.

Calcium and vitamin D3 should be used with caution in immobilized patients with osteoporosis because of the risk of hypercalcemia.

Simultaneous use with antibiotics of the tetracycline or quinolone group is generally not recommended, or should be used with caution (see section “Interaction with other drugs and foods”).

Impact on driving and operating ability

There are no data regarding the effect of Calcium-D3 Nycomed on driving and operating ability.

Contraindications

Hypercalcemia (increased concentration of calcium in the blood).

Hypercalciuria (increased concentration of calcium in the urine).

Nephrolithiasis.

Hypervitaminosis D.

Hypersensitivity to the components of the drug.

Hypersensitivity to soy or peanuts.

Severe renal failure.

Active tuberculosis.

The drug in tablet form is not used in children under 3 years of age.

Calcium-D3 Nicomed contains aspartame which is converted to phenylalanine in the body. Therefore, the drug should not be taken by patients with phenylketonuria.

Chewable tablets (orange, mint) contain sorbitol, isomalt and sucrose.

Chewable tablets (strawberry and watermelon) contain sorbitol and sucrose. Use is not recommended for patients with hereditary fructose intolerance, glucose-galactose malabsorption or sucrose-isomaltase deficiency.

With caution

Pregnancy, lactation, renal failure.

Calcium carbonate with colecalciferol should be prescribed with caution in patients with sarcoidosis because of the risk of increased metabolism of vitamin D3 to its active form. In these patients it is necessary to monitor the concentration of calcium in serum and urine.

Side effects

The frequency of side effects of the drug is rated as follows:

Very frequent: > 1/10

Frequent: > 1/100,

Infrequent: > 1/1000,

Rare: > 1/10,000,

Very rare:

Frequency unknown (cannot be calculated from available data)

Metabolic and nutritional disorders:

Infrequent: hypercalcemia and hypercalciuria.

Very rare: Lactic-alkaline syndrome (Burnett syndrome). Usually observed only in overdose (see section “Overdose”).

Gastrointestinal disorders:

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

Skin and subcutaneous tissue disorders:

Very rare: itching, rash, urticaria.

Immune system disorders:

Prevalence unknown: hypersensitivity reactions such as angioedema or laryngeal edema.

Overdose

Overdose can lead to hypercalcemia and hypervitaminosis D.

The symptoms of overdose (hypercalcemia): anorexia, thirst, polyuria, muscle weakness, nausea, vomiting, constipation, abdominal pain, increased fatigue, bone pain, mental disorders, polydipsia, nephrocalcinosis, urolithiasis and, in severe cases, cardiac arrhythmias. With long-term use of excessive doses (over 2500 mg of calcium) – kidney damage, soft tissue calcinosis.

Lactic-alkaline syndrome (Burnett syndrome) may occur in patients when ingesting large amounts of calcium and well absorbed alkaline solutions.

If signs of overdose are detected, discontinue calcium and vitamin D3, as well as thiazide diuretics and cardiac glycosides, and consult a physician.

Treatment: gastric lavage, fluid replacement, use of loop diuretics (e.g., furosemide), glucocorticosteroids, calcitonin, bisphosphonates.

Plasma electrolytes, renal function and diuresis should be monitored.

In severe cases, central venous pressure (CVP) measurement and electrocardiogram (ECG) monitoring are necessary.

Similarities