Drops for oral administration
Prevention of vitamin D deficiency and diseases associated with its deficiency (rickets, osteomalacia).
Treatment of rickets.
Complex therapy of osteoporosis of various origins.
Hypersensitivity to the components of the drug, especially benzyl alcohol.
Sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.
Vitamin D hypervitaminosis.
Elevated levels of calcium in the blood (hypercalcemia), increased excretion of calcium in the urine (hypercalciuria), urolithiasis (the formation of calcium oxalate stones), including a history of renal osteodystrophy with hyperphosphatemia, pseudohypoparathyroidism.
Acute and chronic liver and kidney diseases, renal failure.
An active form of pulmonary tuberculosis.
Children under 4 weeks of age.
In patients in a state of immobilization.
In patients taking thiazide diuretics, as well as in patients with cardiovascular diseases taking cardiac glycosides (see Interaction with Other Medicines).
During pregnancy and breastfeeding (see section Use during pregnancy and during breastfeeding).
In infants with a predisposition to the early overgrowth of fontanelles (when small sizes of the anterior temples are established from birth).
When taking additional amounts of vitamin D and calcium (for example, as part of other drugs), with a violation of the excretion of calcium and phosphates in the urine, in the treatment of benzothiadiazine derivatives and in immobilized patients (risk of developing hypercalcemia and hypercalciuria) (see section Special instructions).
In patients with the following concomitant diseases: atherosclerosis, heart failure, organic heart lesions, granulomatosis, hyperphosphatemia, phosphate nephrourolithiasis, diseases of the gastrointestinal tract, gastric and duodenal ulcer, hypothyroidism.
If you have one or more of the following diseases and conditions, you should consult your doctor before taking the drug.
When taking the drug, the amount of vitamin D and calcium coming from food and as part of other medicines should be taken into account.
Too high doses of vitamin D3, used continuously or in shock doses can cause chronic hypervitaminosis D3.
High doses of calcium should not be used concomitantly with vitamin D3.
The drug should be used with caution in patients with impaired urinary calcium and phosphate excretion, in the treatment of benzothiadiazine derivatives and in immobilized patients (risk of hypercalcemia and hypercalciuria). In such patients, the level of calcium in the blood plasma and urine should be monitored.
Vitamin D3 should not be taken with pseudohypoparathyroidism, since 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 rickets include nervous irritability, anxiety, trembling with a sharp sound, a flash of light, sleep rhythm disturbances, superficial anxious sleep, sweating, itching of the skin, baldness of the nape, suppleness of the edges of the large fontanel.
The presence of visible bone deformities is typical for moderate and severe rickets, which, as a rule, require hospitalization and complex therapy prescribed by the doctor according to the results of the examination.
Repeated courses of treatment for osteoporosis are possible on the recommendation of a doctor, depending on the results of the assessment of markers of bone metabolism and calcium metabolism. If the doctor prescribed a longer treatment than recommended in the instructions, then you should regularly (every three months of therapy) determine the level of calcium in the blood serum and urine, as well as assess kidney function by measuring the level of creatinine in the blood serum. If necessary, the dose can be adjusted by the doctor in accordance with the level of calcium in the blood serum.
In case of hypercalcemia or the presence of signs of impaired renal function, the dose should be reduced or treatment should be stopped. 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.
Impact on the ability to drive transp. Wed and fur .:
Data on the possible effect of the drug on the ability to drive vehicles and mechanisms are not available.
Dosage and Administration
The drug ComplivitÐÂ® Aqua D3 is taken orally in a spoonful of liquid.
1 drop contains about 500 IU of vitamin D3.
Prevention of rickets: – full-term newborns from 4 weeks of life – 1 drop (500 ME) per day
– premature babies from 4 weeks of life – 2 drops (1000 ME) per day for the first year of life, then 1 a drop (500 ME) per day.
The drug is used during the first two years of a childÐ²Ðâ¢s life, during periods of low insolation (especially in winter).
Treatment of rickets:
In the absence of visible deformations of the skeletal system (mild rickets) – 2-3 drops (1000-1500 ME) per day, continue treatment for 30 days.
In the presence of deformations of the skeletal system characteristic of moderate and severe rickets – 4-8 drops (2000-4000 ME) per day, continue treatment for 30-45 days, the dose and duration of therapy depend on the severity of the changes and are determined by the doctor (see Special instructions).
Prevention of vitamin D deficiency and diseases associated with its deficiency (osteomalacia):
1 drop (500 ME) per day for the entire period accompanied by a deficiency in vitamin D. The minimum duration of the course of prevention is 1 month.
In the complex treatment of osteoporosis: 1-2 drops (500-1000 ME) per day for 3 months. Repeated courses of therapy are possible on the recommendation of a doctor, depending on the results of the assessment of markers of bone metabolism and calcium metabolism (see. Special instructions).
The frequency of adverse reactions has not been determined.
Metabolic and nutritional disorders: hypercalcemia and hypercalciuria.
Disorders of the nervous system: headache.
Disorders of the cardiovascular system: increased blood pressure, arrhythmias.
Disorders of the respiratory system, chest and mediastinal organs: exacerbation of the tuberculous process in the lungs.
Disorders of the gastrointestinal tract: decreased appetite, constipation, flatulence, nausea, abdominal pain or diarrhea.
Disorders of the skin and subcutaneous tissues: hypersensitivity reactions such as pruritus, skin rash and urticaria.
Violations of the musculoskeletal and connective tissue: arthralgia, myalgia.
Disorders of the kidneys and urinary tract: impaired renal function, polyuria.
If you experience any side effects, you should consult a doctor.
Antiepileptic drugs (especially phenytoin and phenobarbital, primidone), rifampicin, colestyramine reduces reabsorption of vitamin D3.
Concomitant use with hyazide diuretics increases the risk of hypercalcemia. In such cases, it is necessary to constantly monitor the concentration of calcium in the blood.
With hypervitaminosis D3, an increase in the action of cardiac glycosides and an increase in the risk of arrhythmias due to the development of hypercalcemia are possible (it is advisable to control the concentration of calcium in the blood, electrocardiograms, as well as adjust the dose of cardiac glycoside).
Concomitant glucocorticosteroid therapy may decrease the effectiveness of vitamin D3.
Long-term use of antacids containing aluminum and magnesium, in combination with vitamin D3, it can increase the concentration of aluminum and magnesium in the blood and, as a result, the toxic effect of aluminum on bone tissue and hypermagnesemia in patients with renal failure.
Colestyramine, colestipol and mineral oils reduce the absorption of fat-soluble vitamins in the gastrointestinal tract 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 hyperphosphatemia.
When used simultaneously with sodium fluoride, the interval between doses should be at least 2 hours with oral forms of tetracyclines – at least 3 hours.
Simultaneous use with other vitamin D analogs increases the risk of vitamin D hypervitaminosis.
Ketoconazole can inhibit both biosynthesis and catabolism of 1,25 (OH) 2-colecalciferol.
Vitamin D is an antagonist of drugs used for hypercalcemia: calcitonin, ethidronate, pamidronate, plicamycin, gallium nitrate.
Isoniazid and rifampicin can reduce the effect of the drug due to an increase in the rate of biotransformation.
Vitamin D3 does not interact with food.
In a dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
Form of Treatment
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