Complivit® Aqua D3 (COMPLIVIT® AQUA D3)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceKolekaltsiferolKolekaltsiferol
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    • Dosage form: & nbspdrops for oral administration
    Composition:

    On 1 ml:

    Active substance: colcalciferol (vitamin D3) - 0.375 * mg (15,000 ME);

    Excipients: macrogol glycerylricinoleate - 75,000 mg; sucrose (white sugar) - 250,000 mg; sodium hydrogen phosphate dodecahydrate - 7,000 mg; citric acid (citric acid monohydrate) - 0.430 mg; anethole - 0.825 mg; benzyl alcohol - 15,000 mg; purified water up to 1 ml.

    * 1 mg of cholecalciferol corresponds to 40,000 ME activity of vitamin D3.

    Description:

    Colorless, clear or slightly opalescent liquid with a characteristic odor.

    Pharmacotherapeutic group:Calcium-phosphorus exchange regulator
    ATX: & nbsp

    A.11.C.C.05   Kolekaltsiferol

    Pharmacodynamics:

    Vitamin D3 is an active antirachitic factor. The most important function of the vitamin D3 is the regulation of the metabolism of calcium and phosphate, which contributes to the proper mineralization and growth of the skeleton.

    Vitamin D3 is a natural form of vitamin D, which is formed in a person in the skin under the influence of sunlight. Compared with vitamin A D2 is characterized by 25% higher activity. Kolekaltsiferol plays an important role in the absorption of calcium and phosphate from the intestine, in the transport of mineral salts and in the process of calcification of bones, also regulates the excretion of calcium and phosphate by the kidneys. The concentration of calcium ions in the blood causes the maintenance of muscle tone of skeletal muscles, the function of the myocardium, promotes the conduction of nervous excitement, regulates the process of blood coagulation. Vitamin D is necessary for the normal function of the parathyroid gland, also participates in the functioning of the immune system, affecting the production of lymphokines.

    Lack of Vitamin D in food, impaired absorption, calcium deficiency, as well as insufficient exposure to sunlight leads to: in children in the period of intensive growth - to rickets, in adults - to osteomalacia, in pregnant women, tetany symptoms may occur, in newborns - violation of calcification processes in the bone tissue. Increased need for a vitamin D occurs in women during menopause in connection with the development of hormonal disorders that lead to osteoporosis.

    Pharmacokinetics:

    An aqueous solution of a vitamin D3 absorbed better than the oil solution. In premature infants, there is insufficient formation and the supply of bile to the intestine, which disrupts the absorption of vitamins in the form of oily solutions. After oral administration colcalciferol absorbed in the small intestine. Metabolised in the liver and kidneys. The half-life of colcalciferol from the blood is several days and can last for renal failure. The drug penetrates through the placental barrier and into the mother's milk. Vitamin D3 possesses the cumulation property. It is excreted from the body by the kidneys in a small amount, most of it is excreted with bile.

    Indications:

    Prevention of vitamin deficiency D and diseases associated with its insufficiency (rickets, osteomalacia).

    Treatment of rickets.

    Complex therapy of osteoporosis of various genesis.

    Contraindications:

    Hypersensitivity to the components of the drug, especially benzyl alcohol.

    Deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.

    Hypervitaminosis of Vitamin D.

    Elevated blood levels of calcium (hypercalcemia), increased urinary excretion of calcium (hypercalciuria), urolithiasis (formation of calcium oxalate stones), includingin history, renal osteodystrophy with hyperphosphatemia, pseudohypoparathyroidism.

    Sarcoidosis.

    Acute and chronic diseases of the liver and kidneys, kidney failure.

    Active form of pulmonary tuberculosis.

    Children up to 4 weeks of life.

    Carefully:

    Patients who are in a state of immobilization.

    In patients taking thiazide diuretics, as well as in patients with cardiovascular diseases, taking cardiac glycosides (see section "Interaction with other drugs").

    During pregnancy and breastfeeding (see section "Application during pregnancy and during breast-feeding").

    In infants with a predisposition to early overgrowing of fontanelles (when the small size of the anterior pubescence is established from birth).

    When taking additional amounts of vitamin A D and calcium (for example, as part of other drugs), with excretion of calcium and phosphate excretion in the urine, in the treatment of benzothiadiazine derivatives and in immobilized patients (risk of hypercalcaemia and hypercalciuria) (see "Special instructions").

    In patients with the following concomitant diseases: atherosclerosis,heart failure, organic heart disease, granulomatosis, hyperphosphataemia, phosphate nefroourolithiasis, gastrointestinal tract diseases, peptic ulcer and duodenal ulcer, hypothyroidism.

    In the presence of one or more of the listed diseases and conditions, it is necessary to consult a doctor before taking the drug.

    Pregnancy and lactation:

    During pregnancy, do not use the drug in doses exceeding the recommended for the prevention of vitamin deficiency D (see section "Method of administration and dose"), because of the possibility of teratogenicity in case of an overdose.

    Caution should be prescribed vitamin D3 in women breastfeeding the baby; a drug taken in high doses by a mother may cause symptoms of an overdose in a child.

    In the case of the drug during pregnancy and during breastfeeding, it is necessary to take into account the intake of vitamin D from other sources, the daily dose of vitamin D should not exceed 600 ME.

    Dosing and Administration:

    Orally.

    The drug Complivit® Aqua D3 take inside the spoon a liquid.

    1 drop contains about 500 ME vitamin A D3.

    Prevention of rickets:

    - term infants from 4 weeks of life - 1 drop (500 ME) per day;

    - premature babies from 4 weeks of life - 2 drops (1000 ME) per day during the first year of life, then 1 drop (500 ME) per day.

    The drug should be used during the first two years of a child's life, during periods of low insolation (especially in winter).

    Treatment of rickets:

    In the absence of visible deformations of the bone system (mild rickets) - 2-3 drops (1000-1500 ME) per day, continue treatment for 30 days.

    In the presence of deformations of the bone system, characteristic for rickets of medium and severe degree - 4-8 drops (2000-4000 ME) per day, the treatment is continued for 30-45 days, the dose of the drug and the duration of therapy depend on the severity of the changes and are determined by the physician (see "Special instructions").

    Prevention of vitamin deficiency D and diseases associated with its insufficiency (osteomalacia):

    on 1 drop (500 ME) per day for the entire period, accompanied by a deficiency in vitamin intake D. The minimum duration of the course of prevention is 1 month.

    In the complex treatment of osteoporosis: on 1-2 drops (500-1000 ME) per day for 3 months. Repeated course of therapy is possible on the advice of a doctor,depending on the results of the evaluation of markers of bone metabolism and calcium metabolism (see "Special instructions").

    Side effects:

    The frequency of undesired reactions is not determined.

    Disorders from the metabolism and nutrition: hypercalcemia and hypercalciuria.

    Impaired nervous system: headache.

    Disorders from the cardiovascular system: increased blood pressure, arrhythmias.

    Disturbances from the respiratory system, chest and mediastinal organs: exacerbation of the tuberculous process in the lungs.

    Disorders from the gastrointestinal tract: loss of appetite, constipation, flatulence, nausea, abdominal pain or diarrhea.

    Disturbances from the skin and subcutaneous tissues: hypersensitivity reactions such as pruritus, skin rash and hives.

    Disturbances from the musculoskeletal and connective tissue: arthralgia, myalgia.

    Disorders from the kidneys and urinary tract: impaired renal function, polyuria.

    If side effects occur, consult a doctor.

    Overdose:

    Symptoms of an acute vitamin D overdose3

    early manifestations (caused by hypercalcemia) - constipation or diarrhea, dryness of the oral mucosa, headache, thirst, pollakiuria, nocturia, polyuria, anorexia, metallic taste in the mouth, nausea, vomiting, general weakness and fatigue, hypercalcemia, hypercalciuria, dehydration;

    late manifestations - pain in the bones, clouding of urine (appearance of hyaline cylinders, proteinuria, leukocyturia in the urine), arterial pressure, pruritus, photosensitivity of the eyes, congestion hyperemia, arrhythmia, drowsiness, myalgia, nausea, vomiting, pancreatitis, gastralgia, psychosis (changes in the psyche) and mood changes.

    Symptoms of Chronic Overdose of Vitamin D3 (with admission for several weeks or months for adults at doses of 20000-60000 IU / day, children - 2000-4000 IU / day): calcification of soft tissues, kidneys, lungs, blood vessels, arterial hypertension, renal and chronic heart failure these effects most often occur with adherence to hypercalcemia of hyperphosphataemia), dysplasia in children (prolonged use at a dose of 1800 IU / day).

    Treatment. If the above symptoms appear, discontinue use of the drug and seek medical attention.A diet with a low calcium content (for several weeks), consumption of large amounts of fluid, diuresis with furosemide, electrolytes, as well as the appointment of glucocorticosteroids, calcitonin is indicated. With proper functioning of the kidneys, the calcium level can be significantly reduced by the infusion of an isotonic sodium chloride solution (3-6 liters within 24 hours) with the addition of furosemide and, in some cases, sodium edetate at a dose of 15 mg / kg / h, monitoring of calcium levels and electrocardiogram data. In oligoanuria, on the contrary, it is necessary to conduct hemodialysis (dialysate without calcium). The specific antidote is unknown.

    To prevent an overdose, in some cases it is recommended to control the concentration of calcium in the blood.

    Interaction:

    Antiepileptic drugs (especially phenytoin and phenobarbital, primidon), rifampicin, colestramine reduce the reabsorption of the vitamin D3.

    Application simultaneously with hyazide diuretics increases the risk of hypercalcemia. In such cases, it is necessary to continuously monitor the concentration of calcium in the blood.

    With hypervitaminosis D3 it is possible to increase the action of cardiac glycosides and increase the risk of arrhythmia due to the development of hypercalcemia (it is advisable to monitor the concentration of calcium in the blood, electrocardiograms, and also adjust the dose of cardiac glycoside).

    Concomitant therapy with glucocorticosteroids may decrease the effectiveness of the vitamin D3.

    Long-term use of angacic agents containing aluminum and magnesium in combination with vitamin D3 can help increase the concentration of aluminum and magnesium in the blood and, as a consequence, the toxic effect of aluminum on bone tissue and hypermagnesia in patients with renal insufficiency.

    Kolestyramin, colestipol and mineral oils reduce absorption in the gastrointestinal tract of fat-soluble vitamins and require an increase in their dose.

    Concomitant use of benzodiazepines increases the risk of hypercalcemia. Preparations containing high concentrations of calcium and phosphorus increase the risk of developing hyperphosphataemia.

    When used simultaneously with sodium fluoride, the interval between the intake should not be less than 2 h; with oral forms of tetracyclines - not less than 3 hours.

    Simultaneous use with other vitamin analogues D increases the risk of vitamin hypervitaminosis D.

    Ketoconazole can inhibit both biosynthesis and catabolism of 1,25 (OH)2-colecalciferol.

    Vitamin D is an antagonist of drugs used in hypercalcemia: calcitonin, etidronate, pamidronate, plikamycin, gallium nitrate.

    Isoniazid and rifampicin can reduce the effect of the drug because of the increased rate of biotransformation.

    Vitamin D3 does not interact with food.

    Special instructions:

    Avoid overdose.

    When taking the drug should take into account the amount of vitamin D and calcium, supplied with food and as part of other medicines.

    Too high doses of vitamin A D3, used for a long time, or shock doses can cause chronic hypervitaminosis D3.

    Do not use simultaneously with vitamin D3 high doses of calcium.

    The drug should be used with caution in patients with impaired excretion of calcium and phosphate in the urine, in the treatment of benzothiadiazine derivatives and in immobilized patients (risk of hypercalcemia and hypercalciuria).These patients should monitor the level of calcium in the blood and urine.

    Do not take a vitamin D3 at pseudohypoparathyroidism, as with this disease the need for vitamin D can be reduced, which can lead to the risk of prolonged overdose.

    The main clinical manifestations of mild rachitis include nervous excitability, anxiety, flinches with sharp sound, a flash of light, disturbance of the rhythm of sleep, superficial "anxious" sleep, sweating, itching of the skin, baldness of the nape, suppleness of the edges of the large fontanel.

    The presence of visible deformations of bone tissue is characteristic for medium and severe rickets, which, as a rule, require hospitalization and complex therapy, appointed by the doctor according to the results of the examination.

    Repeated courses of therapy of osteoporosis are possible on the recommendation of a doctor, depending on the results of evaluation of markers of bone metabolism and calcium metabolism. If the doctor has prescribed a longer treatment than recommended in the instructions, you should regularly (every three months of therapy) determine the level of calcium in the serum and urine, as well as assess the kidney function by measuring the level of serum creatinine.If necessary, the dose can be adjusted by the doctor in accordance with the level of calcium in the blood serum.

    In the case of hypercalcemia or the presence of signs of impaired renal function, the dose of the drug should be reduced or suspended treatment. If the level of calcium in the urine exceeds 7.5 mmol / 24 h (300 mg / 24 h), it is recommended to reduce the dose of the drug or suspend treatment.

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

    Data on the possible effect of the drug on the ability to drive vehicles and mechanisms are not available.

    Form release / dosage:Drops for oral administration, 15000 IU / ml.
    Packaging:

    For 10 ml in bottles of droppers from dark (amber) glass, sealed with polyethylene stoppers, droppers and polyethylene caps with the control of the first autopsy.

    One vial-dropper along with the instruction for use is placed in a pack of cardboard.

    Storage conditions:

    In the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    2 years.

    Do not use after the expiry date printed on the package.

    Terms of leave from pharmacies:Without recipe
    Registration number:LP-004151
    Date of registration:21.02.2017
    Expiration Date:21.02.2022
    The owner of the registration certificate:OTISIFARM, OJSC OTISIFARM, OJSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp29.03.2017
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