Complivit Calcium D3, orange 30 pcs.

Pharmacotherapeutic group: calcium-phosphorus metabolism regulator.

ATC code: [A12AX].

Pharmacological properties

Pharmacodynamics

Combined drug regulating calcium and phosphorus metabolism in the body (bones, teeth, nails, hair, muscles). It reduces resorption (resorption) and increases bone density, compensating the lack of calcium and vitamin D₃ in the body, increases absorption of calcium in the intestine and reabsorption of phosphate in the kidneys, promotes mineralization of bones and teeth.

Calcium is involved in the formation of bone tissue, in maintaining a stable cardiac function, in the regulation of nerve conduction, muscle contractions, production of hormones and is a component of the blood clotting system.

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

Vitamin D₃ (colecalciferol) increases the absorption of calcium in the intestine and promotes the formation and mineralization of bone and dental tissue.

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

Pharmacokinetics.

Calcium

Intake: Calcium is absorbed in ionized form in the proximal small intestine through an active, D-vitamin dependent transport mechanism. Typically, the amount of calcium absorbed in the gastrointestinal tract is approximately 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.

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 easily absorbed in the small intestine (about 80% of the dose taken).

Distribution and metabolism: coleciferol and its metabolites circulate in the blood, bound to a specific globulin. Colocalciferol is converted in the liver by hydroxylation to 25-hydroxycalciferol.

It is then converted in the kidneys to the active form 1,25-hydroxycalciferol, responsible for increasing calcium absorption in the intestine and tubular reabsorption in the kidneys. Unmetabolized vitamin D₃ is deposited in fat and muscle tissue. 3 is excreted by the intestine and kidneys.

Indications

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

Prevention and complex therapy of osteoporosis and its complications (bone fractures).

Pharmacological effect

Pharmacotherapeutic group: calcium-phosphorus metabolism regulator.

ATX code: [A12AX].

Pharmacological properties

Pharmacodynamics

A combined drug that regulates the exchange of calcium and phosphorus in the body (bones, teeth, nails, hair, muscles). Reduces resorption (resorption) and increases bone density, replenishing the lack of calcium and vitamin D3 in the body, enhances the absorption of calcium in the intestines and the reabsorption of phosphates in the kidneys, promotes the mineralization of bones and teeth.

Calcium is involved in the formation of bone tissue, in maintaining stable cardiac activity, in the regulation of nerve conduction, muscle contractions, hormone production, and is a component of the blood coagulation system.

Adequate calcium intake is especially important during growth, pregnancy and lactation.

Vitamin D3 (colecalciferol) – increases the absorption of calcium in the intestine, promotes the formation and mineralization of bone and dental tissue.

The use of calcium and vitamin D3 prevents an increase in the production of parathyroid hormone (PTH), which is a stimulator of increased bone resorption (leaching of calcium from the bone).

Pharmacokinetics.

Calcium

Absorption: Calcium is absorbed in ionized form in the proximal small intestine through an active, D-vitamin dependent transport mechanism. Typically, the amount of calcium absorbed in the gastrointestinal tract is approximately 30% of the dose taken.

Distribution and Metabolism: 99% of calcium in the body is concentrated in the rigid structure of bones and teeth. The remaining 1% is found in intra- and extracellular fluids.

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

Vitamin D3

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

Distribution and metabolism: colecalciferol and its metabolites circulate in the blood bound to a specific globulin. Colecalciferol is converted in the liver by hydroxylation to 25-hydroxycalciferol.

It is then converted in the kidneys to the active form 1,25-hydroxycalciferol, which is responsible for increasing calcium absorption in the intestine and tubular reabsorption in the kidneys. Unmetabolized vitamin D3 is stored in adipose and muscle tissue.

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

Special instructions

During long-term therapy, serum calcium and creatinine levels should be monitored. Monitoring is especially important in elderly patients during concomitant treatment with cardiac glycosides and diuretics (see section “Interactions with other drugs and foods”) and in patients with an increased tendency to form kidney stones.

In cases of hypercalcemia or signs of renal impairment, reduce the dose or discontinue treatment.

Vitamin D3 should be taken with caution in patients with renal failure. In this case, it is necessary to monitor the calcium and phosphate levels in the blood serum. The risk of soft tissue calcification must also be considered.

To avoid overdose, additional vitamin D intake from other sources must be taken into account.

In older people, the need for calcium is 1500 mg/day, for vitamin D3 – 0.5-1 thousand IU/day.

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

Concomitant use with tetracycline or quinolone antibiotics is usually not recommended or should be done with caution (see section “Interaction with other drugs and foods”).

Impact on the ability to drive vehicles and machinery.

The drug Complivit® Calcium D3 does not affect the ability to drive vehicles or work with technically complex mechanisms.

Active ingredient

Calcium carbonate, Colecalciferol

Composition

Active ingredients:

Calcium – 500 mg (in the form of calcium carbonate – 1.250 g).

Colecalciferol (vitamin D3) – 0.005 mg (200 IU) (in terms of 100% colecalciferol) (in the form of granulate containing colecalciferol – 0.27%, D,L-alpha-tocopherol – 0.0275%, medium chain triglycerides – 10.7%, sucrose – 36 %, acacia gum – 22%, corn starch – 27%, calcium phosphate (E 341) – 0.5%, water up to 100%).

Excipients: lactose monohydrate – 327.406 mg, povidone (medium molecular weight polyvinylpyrrolidone, povidone K 30) – 68.223 mg, potato starch – 20.541 mg, croscarmellose sodium – 49.875 mg, citric acid (in the form of citric acid monohydrate) – 3.325 mg, aspartame (E 951) – 5.95 mg, magnesium stearate – 15.75 mg, orange flavor (powder) – 8.925 mg.

Pregnancy

Complivit® Calcium D3 is used during pregnancy to replenish calcium and vitamin D deficiency in the body. During pregnancy, the daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D3. Hypercalcemia due to overdose during pregnancy can have an adverse effect on the developing fetus.

Complivit® Calcium D3 is used during lactation. Calcium and vitamin D3 can pass into breast milk, so you should
take into account the intake of calcium and vitamin D from
other sources from mother and child.

Contraindications

Hypersensitivity to the components of the drug.

Hypercalcemia (increased concentration of calcium in the blood).

Hypercalciuria (increased calcium in urine).

Nephrolithiasis.

Hypervitaminosis D.

Decalcifying tumors (myeloma, bone metastases, sarcoidosis).

Active tuberculosis.

Severe renal failure.

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

Complivit® Calcium D3 contains aspartame, which is transformed into phenylalanine in the body. Therefore, the drug should not be taken by patients with phenylketonuria.

The drug contains lactose and sucrose, so its use is not recommended for patients with hereditary intolerance to lactose, fructose, glucose-galactose malabsorption, lactase or sucrase/isomaltase deficiency.

With caution: pregnancy, lactation, renal failure.

Side Effects

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

Very common: > 1/10

Frequent: >1/100, <1/10

Uncommon: >1/1000, <1/100

Rare: > 1/10,000, < 1/1000

Very rare: < 1/10,000

Metabolic and nutritional disorders: uncommon – hypercalcemia, hypercalciuria.

Gastrointestinal disorders: rarely – constipation, flatulence, nausea, abdominal pain, diarrhea, dyspepsia.

Skin and subcutaneous tissue disorders: very rarely – allergic reactions (itching, rash, urticaria).

Interaction

The activity of vitamin D3 may be decreased when used concomitantly with phenytoin or barbiturates.

Hypercalcemia can potentiate the toxic effects of cardiac glycosides when used simultaneously with calcium and vitamin D preparations. Monitoring of ECG and serum calcium levels is necessary.

Calcium supplements may reduce the absorption of tetracyclines from the gastrointestinal tract. Therefore, tetracycline drugs should be taken at least 2 hours before or 4-6 hours after taking Complivit® Calcium D3.

To prevent decreased absorption of bisphosphonate drugs, it is recommended to take them at least an hour before taking Complivit® Calcium D3.

Glucocorticosteroids reduce calcium absorption, so treatment with glucocorticosteroids may require an increase in the dose of Complivit® Calcium D3.

Simultaneous treatment with colesteramine preparations or laxatives based on mineral or vegetable oil may reduce the absorption of vitamin D3.

With simultaneous use of thiazide diuretics, the risk of hypercalcemia increases, as they increase tubular reabsorption of calcium. When using thiazide diuretics simultaneously, serum calcium levels should be regularly monitored. Furosemide and other “loop” diuretics, on the contrary, increase calcium excretion by the kidneys.

Calcium reduces the effectiveness of levothyroxine by reducing its absorption. The period of time between doses of levothyroxine and Complivit® Calcium D3 should be at least 4 hours.

The absorption of quinolone antibiotics is reduced when used simultaneously with calcium supplements. Therefore, quinolone antibiotics should be taken 2 hours before or 6 hours after taking Complivit® Calcium D3.

Eating foods containing oxalates (sorrel, rhubarb, spinach) and phytin (cereals) reduces calcium absorption, so you should not take Complivit® Calcium D3 within 2 hours after eating sorrel, rhubarb, spinach and cereals.

Overdose

Symptoms of overdose (hypercalcemia): thirst, polyuria, anorexia, nausea, vomiting, constipation, abdominal pain, dizziness, muscle weakness, fatigue, bone pain, mental disorders, headache, fainting, coma, nephrocalcinosis, urolithiasis, in severe cases – cardiac arrhythmias.

With long-term use of excessive doses (over 2500 mg of calcium) – kidney damage, soft tissue calcification.

Laboratory indicators in case of overdose: hypercalciuria, hypercalcemia (plasma calcium about 2.6 mmol).

If signs of overdose are detected, you should stop taking calcium and vitamin D, as well as thiazide diuretics and cardiac glycosides, and consult a doctor.

Treatment: gastric lavage, replenishment of fluid loss, use of loop diuretics (for example, furosemide), glucocorticosteroid drugs, calcitonin, bisphosphonates, calcium-restricted diet, hemodialysis.

It is necessary to monitor the content of electrolytes in the blood plasma, renal function and diuresis.

In severe cases, it is necessary to measure central venous pressure (CVP) and monitor the electrocardiogram (ECG).

Storage conditions

At a temperature not higher than 25 0C.

Keep out of the reach of children.

Shelf life

3 years.

Manufacturer

Pharmstandard-UfaVITA, Russia