Composition, form of production and packaging
? Mouth round chewable tablets , white, labeled "ALPHARMA" on the one hand, with a characteristic mint smell.
1 tab.
calcium 218 mg
Colcalciferol (Vit. D 3 ) 400 IU
Excipients: mannitol, povidone K90, aspartame, lactose, povidone (K-30), mint flavor, magnesium stearate, talc.
30 pcs. - vials of polyethylene terephthalate (1) - packs of cardboard.
? Chewable chocolate round tablets , brown, labeled "ALPHARMA" on the one hand, with a characteristic chocolate smell; presence of inclusions is allowed.
1 tab.
calcium 218 mg
Colcalciferol (Vit. D 3 ) 400 IU
Excipients: mannitol, aspartame, povidone K90, lactose, cocoa beans powder, vanillin, brown chocolate dye, chocolate flavor, magnesium stearate, talc.
30 pcs. - vials of polyethylene terephthalate (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2014.
PHARMACHOLOGIC EFFECT
Combined drug regulating the exchange of calcium and phosphorus in the body. Reduces resorption (resorption) and increases the density of bone tissue, replenishing the lack of calcium and vitamin D 3 in the body. It is necessary for mineralization of teeth and bones.
Calcium
Regulator of calcium-phosphorus metabolism. Replenishes calcium deficiency in the body, normalizes the electrolyte balance of calcium and phosphorus. Calcium is involved in the regulation of nerve conduction, muscle contractions and is a component of the blood coagulation system.
Kolekaltsiferol (Vitamin D3)
The calcium-phosphorus metabolism regulator enhances the absorption of calcium ions (Ca 2+ ) and phosphate in the intestine (by increasing the permeability of cellular and mitochondrial membranes of the intestinal epithelium) and their reabsorption in renal tubules of the kidneys; promotes the mineralization of bones, enhances the process of ossification, is necessary for the normal functioning of parathyroid glands.
PHARMACOKINETICS
Absorption is rapid (in the distal part of the small intestine), enters the lymphatic system, enters the liver and into the general bloodstream. In the blood, it binds to alpha- 2 globulins and partly to albumins. It accumulates in the liver, bones, skeletal muscles, kidneys, adrenal glands, myocardium, adipose tissue. The time to reach the maximum concentration in the tissues is 4-5 h, then the concentration of the drug is somewhat reduced, remaining for a long time constant. In the form of polar metabolites is localized mainly in the membranes of cells and microsomes, mitochondria and 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 turns into an inactive metabolite, calciphediol (25-dihydrocholecalciferol), in the kidney - from calciphediol it turns into active metabolite calcitriol (1,25-dihydroxycholecalciferol) and inactive metabolite 24,25-dihydroxycholecalciferol. Undergoes intestinal-hepatic recirculation.
Vitamin D and its metabolites are excreted with bile, a small amount - by the kidneys. Accumulated in the body
Calcium is absorbed in ionized form in the proximal small intestine by means of an active, D-vitamin dependent transport mechanism.
INDICATIONS
Replenishment of deficiency of calcium and vitamin D3 in the body, especially during an increased need:
- Children's age in the period of intensive growth;
- elderly age;
- the period of menopause;
- Pregnancy and lactation.
DOSING MODE
To fill the deficiency of calcium and / or vitamin D3 in the body of adults and children over 12 years - 1 tablet once a day.
During pregnancy and lactation - 1 tablet once a day. The tablet can be chewed or swallowed whole.
SIDE EFFECT
From the digestive system: decreased appetite, constipation or diarrhea, flatulence, pain in the epigastric region, nausea.
From the urinary system: polyuria, impaired renal function.
Other: allergic reactions; hypercalcemia, hypercalciuria, headache, myalgia, arthralgia, increased blood pressure, arrhythmias, exacerbation of the tuberculous process in the lungs.
CONTRAINDICATIONS
hypersensitivity to the components of the drug;
- hypercalcemia (including as a result of hyperparathyroidism primary or secondary);
- hypercalciuria;
- Nephrolithiasis;
- active form of tuberculosis;
- Vitamin D3 hypervitaminosis;
- simultaneous reception with other vitamin complexes containing calcium and vitamin D3;
- decalcifying tumors (myeloma, bone metastases, sarcoidosis);
- Osteoporosis caused by prolonged immobilization;
- phenylketonuria (contains asnartam);
- severe form of chronic kidney failure;
- children's age till 12 years;
- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption.
With caution: pregnancy and lactation.
PREGNANCY AND LACTATION
The daily dose should not exceed 1500 mg of calcium and 600 IU of vitamin D3. Hypercalcemia, developing against an overdose, during pregnancy can cause defects in the child's mental and physical development.
Vitamin D and its metabolites can penetrate into breast milk, so you need to consider the intake of calcium and vitamin D from other sources in the mother and child.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated in severe form of chronic renal failure.
APPLICATION FOR CHILDREN
Contraindicated in children under 12 years.
APPLICATION IN ELDERLY PATIENTS
Permitted to use. In elderly people, the need for Ca 2+ is 1.5 g / day, in vitamin D3 - 0.5-1 thousand IU / day.
SPECIAL INSTRUCTIONS
During the period of treatment, it is necessary to constantly control the excretion of Ca 2+ in the urine and the concentration of Ca 2+ and creatinine in the plasma (in case of calcification, exceeding 7.5 mmol / day (300 mg / day), it is necessary to reduce the dose or stop taking). Contains aspartame, which is metabolized in the body to phenylalanine, which is necessary
Consider in patients with phenylketonuria.
In order to avoid an overdose, it is necessary to take into account the additional intake of vitamin D3 from other sources. Do not apply simultaneously with vitamin complexes containing Ca 2+ and vitamin D 3. Do not take the drug for 2 hours after taking sorrel, spinach, cereals.
In elderly people, the need for Ca 2+ is 1.5 g / day, in vitamin D3 - 0.5-1 thousand IU / day.
Influence on the ability to drive and work with machinery
The drug does not affect the speed of psychomotor reactions when driving and working with mechanisms.
OVERDOSE
In case of overdose, the following symptoms are possible: thirst and polyuria (as signs of chronic kidney failure), decreased appetite, nausea, vomiting, constipation, dizziness, weakness, headache, fainting, coma; with prolonged use: calcification of blood vessels and tissues.
Laboratory indicators for overdose: hypercalciuria, hypercalcemia (Ca 2+ in plasma about 2.6 mmol / l).
Treatment: rehydration, "loop" diuretics, glucocorticosteroids (GCS), calcitonin, bisphosphonates, hemodialysis.
DRUG INTERACTION
The intake of food products containing oxalates (sorrel, spinach) and phytin (cereals), reduces the absorption of calcium.
In hypervitaminosis D, cardiac glycosides may increase their activity and increase the risk of their toxicity, including an increased risk of arrhythmia due to the development of hypercalcemia (it is appropriate to correct the dose of cardiac glycoside). When co-administered with cardiac glycosides, it is necessary to monitor the ECG and the clinical condition of the patient.
Under the influence of barbiturates (including phenobarbital), phenytoin and primidone, the need for colcalciferol can significantly increase (increase the metabolic rate) Calcitonin, etidronic acid, pamidronic acid, plikamycin reduce the effect. GCS decreases calcium absorption, therefore, patients receiving SCS may require an increase in the dose of the preparation Calcium-Dz Aktavis.
Kolestyramin, colestipol and mineral oils reduce absorption in the gastrointestinal tract of vitamin D 3 and require an increase in their dose.
When used simultaneously with sodium fluoride and bisphosphonates, the interval between the intake should be at least 2 hours, as there is a decrease in their absorption. Preparations of calcium and vitamin D3 can reduce the absorption of tetracyclines from the gastrointestinal tract, so the interval between the intake of Calcium-Dz Actavis and antibiotics of the tetracycline group should be at least 3 hours.
Simultaneous application with other analogues of vitamin D increases the risk of hypervitaminosis.
Thiazide diuretics increase the risk of hypercalcemia due to increased tubular calcium reabsorption. Furosemide and other "loop" diuretics, on the contrary, increase the excretion of calcium by the kidneys.
TERMS OF RELEASE FROM PHARMACY
On prescription.
TERMS AND CONDITIONS OF STORAGE
In a dry, the dark place at a temperature of no higher than 30 В° C. Keep out of the reach of children! Shelf life - 3 years.
