Calcium-D3 Aktavis (Calcium-D3 Actavis)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsp

chewing tablets (mint, chocolate)

Composition:

1 tablet of chewing chocolate contains:

Active substances: calcium hydrophosphate 333.34 mg and calcium citrate 666.66 mg (equivalent to 218 mg of calcium), colcalciferol (Vitamin D3) 400 IU (granulate ** 850/40 5.334 mg).

Excipients: mannitol, aspartame (E 951), povidone - K90 (plasdon - K90), lactose 200, cocoa beans powder, brown chocolate dye, vanillin, chocolate flavor, magnesium stearate, talc.

1 tablet chewing mint contains:

Active substances: calcium hydrophosphate 333.34 mg and calcium citrate 666.66 mg (equivalent to 218 mg of calcium), colcalciferol (Vitamin D3) 400 IU (granulate 850/40 5.334 mg).

Excipients: mannitol, aspartame (E 951), povidone - K90 (plasdon - K90), lactose 200, povidone - K30 (polyvidone - K30), peppermint E5385, magnesium stearate, talc.

** - Vitamin D3 is dispersed in a gelatin-sucrose matrix (coated with corn starch). The granulate contains (dl-α-tocopherol as an antioxidant.

Description:

For chocolate chewable tablets: Round tablets of brown color, marked "ALPHARMA" on the one hand, with a characteristic chocolate smell. Presence of impregnations is allowed.

For tablets of masticatory mints: round tablets of white color, marked "ALPHARMA "on the one hand, with a characteristic mint smell.

Pharmacotherapeutic group:Calcium-phosphorus exchange regulator
ATX: & nbsp
  • Calcium preparations in combination with other drugs
    • Pharmacodynamics:

    Combined drug regulating the exchange of calcium and phosphorus in the body.

    Reduces resorption (resorption) and increases the density of bone tissue, filling the lack of calcium and vitamin D3 in organism. It is necessary for mineralization of teeth and bones.

    Calcium

    Regulator of calcium-phosphorus metabolism. It 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)

    Regulator of calcium-phosphorus metabolism, enhances the absorption of calcium ions (Ca2+) 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 binds with alpha2globulins and partially with albumins.It accumulates in the liver, bones, skeletal muscles, kidneys, adrenals, 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 becomes an inactive metabolite, calciphediol (25-dihydrocholecalciferol), in kidneys - from calciphediol it becomes an active metabolite calcitriol (1,25-dihydroxycholecalciferol) and the inactive metabolite 24,25-dihydroxycholecalciferol. Undergoes intestinal-hepatic recirculation.

    Vitamin D and its metabolites are excreted with bile, a small amount - by the kidneys. It accumulates 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 calcium and vitamin D deficiency3 in the body, especially during an increased need - a child's age in the period of intensive growth, elderly age, the period of menopause, pregnancy and lactation.
    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 D hypervitaminosis3;
    • simultaneous reception with other vitamin complexes containing calcium and vitamin D3;
    • decalcifying tumors (myeloma, bone metastases, sarcoidosis);
    • osteoporosis caused by prolonged immobilization;
    • phenylketonuria (contains aspartame);
    • severe form of chronic renal failure;
    • children's age till 12 years;
    • deficiency of lactase, lactose intolerance, glucose-galactose malabsorption.

    Carefully: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.

    Dosing and Administration:

    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 effects:

    From the digestive system: loss of appetite, constipation or diarrhea, flatulence, epigastric pain, 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.

    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 (Ca2+ in the plasma about 2.6 mmol / l).

    Treatment: rehydration, "loop" diuretics, glucocorticosteroids (GCS), calcitonin, bisphosphonates, hemodialysis.

    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, so patients receiving SCS may require an increase in the dose of Calcium-D3 Aktavis.

    Colestramine, colestipol and mineral oils reduce absorption in the gastrointestinal tract of the vitamin D3 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 Calcium-D3 Actavis and antibiotics of the tetracycline group should be at least 3 h.

    Simultaneous application with other analogues of vitamin O 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.

    Special instructions:

    During the period of treatment, it is necessary to constantly monitor the excretion of Ca2+ with urine and concentration of Ca2+ 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 in phenylalanine, which must be taken into account in patients with phenylketonuria.

    In order to avoid an overdose, it is necessary to take into account the supplementary intake of the vitamin D3 from other sources.

    Do not apply simultaneously with vitamin complexes containing Ca2+ and vitamin D3 Do not take the drug for 2 hours after taking sorrel, spinach, cereals.

    In the elderly, the need for sa2+ is 1.5 g / day, in the vitamin D3 - 0.5-1 thousand IU / day.

    Effect on the ability to drive transp. cf. and fur:

    The drug does not affect the speed of psychomotor reactions when driving and working with mechanisms.

    Form release / dosage:

    Tablets are chewing (mint, chocolate).

    Packaging:

    For 30 tablets in a bottle of polyethylene terephthalate (PET), sealed with a plastic lid. For 1 bottle in a pack of cardboard with instructions for use.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 30 ° C.

    Keep out of the reach of children!

    Shelf life:

    3 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LSR-006120/10
    Date of registration:30.06.2010
    Expiration Date:Unlimited
    The owner of the registration certificate:AKTAVIS GROUP, AO AKTAVIS GROUP, AO Iceland
    Manufacturer: & nbsp
    Representation: & nbspAktavis, Open Company Aktavis, Open Company
    Information update date: & nbsp25.11.2017
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