Calcium + Vitamin D3 Vitrum - instructions for use, dose, side effects, contraindications

The cholecalciferol granulate contains: colcalciferol (Vitamin D₃), d_l-alpha tocopherol, soya bean oil hydrogenated, gelatin hydrolyzate, sucralose, corn starch.

Excipients: microcrystalline cellulose 26.36 mg, silicon dioxide colloid 28.1 mg, magnesium stearate 15.5 mg, croscarmellose sodium 19 mg.

Shell: hypromellose 16 mg, triacetin 0.004 mg, titanium dioxide 9 mg, riboflavin 0.09 mg, colorless diamond blue (E133) 0.01 mg.

Description:Oval-shaped tablets, coated with a film coat of light green color.

Pharmacotherapeutic group:Calcium-phosphorus exchange regulator

ATX: & nbsp

A.12.A.X Calcium preparations in combination with other drugs

Pharmacodynamics:

Combined drug regulating the exchange of calcium and phosphorus in the body. Reduces resorption (leaching calcium from the bones) and increases the density of bone tissue, making up for the lack of calcium and colcalciferol in the body. Kolekaltsiferol increases the absorption of calcium in the gastrointestinal tract and its binding in bone tissue.

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

Pharmacokinetics:

Absorption of colcalciferol - fast (in the distal small intestine), enters the lymphatic system, enters the liver and into the general bloodstream. In the blood it binds to alpha2-globulins and partly to albumins.It accumulates in the liver, bones, skeletal muscles, kidneys, adrenals, myocardium, adipose tissue. Time to reach the maximum concentration (T_Сmах) in tissues - 4-5 hours, then the concentration of colcalciferol decreases slightly, remaining for a long time on a constant basis. In the form of polar metabolites is localized mainly in the membranes of cells and microsomes, mitochondria and cell nuclei. Penetrates through the placental barrier, penetrates into breast milk. It is deposited in the liver. It is metabolized in the liver and kidneys: in the liver it becomes an inactive metabolite, calciphediol (25-dihydrocholecalciferol), in kidneys - from calciphediol it becomes an active metabolite calcitriol (1,25-dihydroxycholecalciferol) and inactive metabolite 24, 25-dihydroxycholecalciferol. Undergoes intestinal-hepatic recirculation. Kolekaltsiferol and its metabolites are excreted with bile, a small amount - by the kidneys. Cumulates.

Approximately 1 / 5-1 / 3 part of the orally administered calcium is absorbed in the proximal small intestine; this process depends on the presence of colcalciferol, pH, dietary characteristics and the presence of factors capable of binding calcium ions (Ca²⁺).The absorption of calcium increases with its deficiency and the use of a diet with a reduced content of calcium ions (Ca²⁺). In plasma about 45% is in complex with proteins. About 20% is excreted by the kidneys, the rest (80%) is removed from the intestinal contents.

Indications:

It is used as a therapeutic and prophylactic drug:

- to fill the deficiency of calcium and / or colcalciferol (vitamin D₃) during the period of intensive growth in adolescence and adolescence, women during pregnancy and lactation;

- for prevention and complex therapy of osteoporosis (menopausal, senile, steroid, idiopathic, etc.) and its complications (bone fractures);

- to fill the lack of calcium and colcalciferol in the elderly.

Contraindications:

- Hypersensitivity to one of the components of the drug;

- vitamin hypervitaminosis D;

- severe renal dysfunction;

- hypercalcemia (elevated calcium in the blood - in individuals with increased function of parathyroid glands);

- hypercalciuria (increased excretion of calcium in the urine);

- urolithiasis (formation of calcareous stones);

- decalcifying tumors (myeloma, bone metastases);

- sarcoidosis;

- osteoporosis due to immobilization;

- pulmonary tuberculosis (active form);

- children's age until 12 years.

Pregnancy and lactation:

The need for calcium and colcalciferol during pregnancy and during breastfeeding is increasing. When taking the drug must take into account the additional intake of calcium and colcalciferol from other sources and constantly monitor the excretion of calcium in the urine and the concentration of calcium and creatinine in the plasma.

To avoid toxic effects on the fetus, it is not recommended to take more than 1500 mg of calcium and 600 ME colcalciferol per day. Calcium and colcalciferol penetrate into breast milk.

Dosing and Administration:

Before use, consult a doctor.

Inside.

As a therapeutic and prophylactic agent for the replacement of calcium and / or colcalciferol deficiency by 1-2 pills a day; for prevention and complex therapy of osteoporosis and its complications in 2 tablets a day, one in the morning and one in the evening, mainly during meals.

The course of treatment in accordance with the recommendations of a doctor.

To increase absorption of calcium, it is preferable to take the tablet with a sour drink (orangeor lemon juice).

Side effects:

Possible allergic reactions to the components of the drug.

Dysfunction of the gastrointestinal tract may be observed (constipation, diarrhea, flatulence, nausea, abdominal pain).

In the case of long-term use, an increase in the calcium content of the blood and urine is possible.

Overdose:Symptoms of acute or chronic overdose are hypercalcemia and / or hypercalciuria, which are expressed by anorexia, nausea, vomiting and dizziness, weakness, headache. In these cases, the drug is recommended to stop.

It is necessary to enter into the body a large amount of fluid and adhere to a diet with a limited amount of calcium. When symptoms of an overdose occur, consult a doctor.

Interaction:

Kolekaltsiferol:

- The activity of colcalciferol can be reduced by its simultaneous use with phenytoin or barbiturates;

- colestyramine, laxatives (vaseline oil) reduce the absorption of colcalciferol.

Calcium carbonate:

- while simultaneous treatment with cardiac glycosides, ECG and clinical control are necessary, because calcium enhances the action of cardiac glycosides;

- slows the absorption of antibiotics of the tetracycline group, acetylsalicylic acid and other salicylates, sulfonamides, beta-blockers and anticoagulants of indirect action. In this regard, the drug is recommended to use for 2 hours or 2 hours after taking other medicines;

- while the simultaneous use of diuretics from the group of thiazides increases the risk of hypercalcemia.

Special instructions:

It is recommended to take with caution those with renal insufficiency. It is necessary to constantly monitor the excretion of calcium in the urine and the concentration of calcium and creatinine in the plasma during the period of treatment (in case of calciuria, exceeding 7.5 mmol / day (300 mg / day), it is necessary to reduce the dose or stop taking).

In the elderly, the need for calcium is 1.5 g / day, in colcalciferol - 500-1000 IU / day. To avoid overdose, it is necessary to take into account the additional intake of colcalciferol from other sources.

Do not use simultaneously with vitamin complexes containing calcium and colcalciferol.

Form release / dosage:

Tablets coated with a film coating, 500 mg + 200 ME.

Packaging:

For 30, 60, 100 or 120 tablets coated with a film sheath in a bottle of polyethylene with a screw cap made of the same material and a safety valve made of foil. The label is attached to the bottle, the bottle is tightened with a polyethylene film and, together with the instruction for use, is placed in a cardboard box.

Storage conditions:

In a dry place, at a temperature of 10 to 30 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date.

Terms of leave from pharmacies:Without recipe

Registration number:П N014802 / 01

Date of registration:22.11.2011

Expiration Date:Unlimited

The owner of the registration certificate:Unipharm, Inc.Unipharm, Inc. USA

Manufacturer: & nbsp

UNIPHARM ,, Inc. USA

Representation: & nbspUNIFARM, Inc. UNIFARM, Inc. USA

Information update date: & nbsp25.11.2017

Illustrated instructions

Instructions

Calcium + Vitamin D3 Vitrum® (Calcium + Vitamin D3 Vitrum®)