Vitamin D3 - instructions for use, dose, side effects, contraindications

In the composition of the substance of colcalciferol present dl-alpha-tocopherol acetate. In 1 ml of the drug dl-alpha-tocopherol acetate is contained in an amount of 0.05 mg.

Description:

Transparent liquid slightly yellowish in color.

Pharmacotherapeutic group:Regulator of calcium-phosphorus metabolism

ATX: & nbsp

A.11.C.C.05 Kolekaltsiferol

Pharmacodynamics:

Remedy for vitamin deficiency D₃. Participates in the regulation of calcium-phosphorus metabolism, enhances the absorption of calcium and phosphate in the intestine (by increasing the permeability of cellular and mitochondrial membranes of the intestinal epithelium) and their reabsorption in the renal tubules; promotes the mineralization of bones, the formation of the skeleton and teeth in children, enhances the process of ossification, is necessary for the normal functioning of the 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, adrenals, myocardium, adipose tissue. The time to reach the maximum concentration in the tissues is 4-5 hours, then the concentration of colcalciferol decreases slightly, remaining for a long time at a constant level. In the form of polar metabolites is localized mainly in cell membranes, macro, mitochondria and nuclei. Penetrates through the placental barrier, excreted in 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-dihydrocolecalciferol), in kidneys - from calciphediol it turns into an active metabolite calcitriol (1,25-dihydroxycolecalciferol) and the inactive metabolite 24,25-dihydroxycolecalciferol. Undergoes intestinal-hepatic recirculation.

Vitamin D₃ and its metabolites are excreted with bile, a small amount - by the kidneys.

Indications:

- Prophylaxis and treatment of rickets;

- Prevention of vitamin deficiency D₃ in high-risk groups (malabsorption, chronic diseases of the small intestine, biliary cirrhosis, condition after resection of the stomach and / or small intestine);

- Supportive therapy of osteoporosis (of various origins);

- Treatment of osteomalacia (against the background of disorders of mineral metabolism in patients older than 45 years, prolonged immobilization in case of injuries, compliance with diets with refusal to accept milk and dairy products);

- Treatment of hypoparathyroidism and pseudohypoparathyroidism.

Contraindications:

Hypersensitivity (including thyrotoxicosis), hypercalcemia, hypervitaminosis D₃, renal osteodystrophy with hyperphosphatemia, calcium nephrolythiasis.

Carefully:

Atherosclerosis, heart failure, renal failure, pulmonary tuberculosis (active form), sarcoidosis or other granulomatosis, hyperphosphataemia, phosphate nephrourolythiasis, organic heart lesions, acute and chronic liver and kidney diseases, gastrointestinal diseases, stomach ulcer and 12intestines, pregnancy, lactation, hypothyroidism.

If you have any of these diseases, consult a doctor before taking the drug.

Pregnancy and lactation:

Chronic overdose (hypercalcemia, penetration of vitamin metabolites D₃ through the placenta), which occurs during pregnancy in the case of prolonged use of the drug in high doses, can cause defects in the physical and mental development of the fetus, special forms of aortic stenosis.

Vitamin D₃ and its metabolites are excreted in breast milk.

Dosing and Administration:

Dosing from vials not equipped with droppers, it is necessary to carry out with the help of an eye dropper. 1 A drop from the eye dropper or plug / cap-cap contains 625 ME vitamin A D₃.

A solution for ingestion in the oil is given in a spoonful of milk or other liquid.

- Prevention of rickets: full-term healthy children Vitamin D₃ It is appointed with a shore of a week of a life on 1 drop (about 625 ME) daily. Premature babies are prescribed 2 drops of Vitamin D₃ (about 1250 ME) per day from the 2nd week of life daily. The drug is prescribed during the first and second years of life, especially in the winter.

- For the treatment of rickets, 2 to 8 drops of Vitamin D₃ (about 1250 - 5000 ME) in a day. Treatment continues throughout the year.

- Prevention of the risk of diseases associated with vitamin deficiency D₃: 1-2 drops of Vitamin D₃ (about 625 - 1250 ME) in a day.

- Prevention of vitamin deficiency D₃ with malabsorption syndrome: from 5 to 8 drops of Vitamin D₃ (about 3125 - 5000 ME) in a day.

- Supportive therapy of osteoporosis: from 2 to 5 drops of Vitamin D₃ (about 1250 - 3125 ME) in a day.

- Treatment of osteomalacia caused by vitamin deficiency D₃: from 2 to 8 drops of Vitamin D₃ (about 1250 - 5000 ME) in a day. Treatment continues throughout the year.

- Treatment of hypoparagyreosis and pseudohypoparathyroidism: Depending on the concentration of calcium in the plasma, 16 to 32 drops of Vitamin D₃ (about 10,000 - 20,000 ME) in a day. If a higher dose is required, the administration of drugs with a higher dosage is recommended. The concentration of calcium in the blood should be checked for 4-6 weeks, then every 3-6 months and adjust the dose according to the normal calcium content in the blood.

Side effects:

Allergic reactions. Hypercalcemia, hypercalciuria, decreased appetite, polyuria, constipation, flatulence, nausea, abdominal pain, headache, myalgia, arthralgia, increased blood pressure, arrhythmias, impaired renal function, exacerbation of the tuberculous process in the lungs.

If any of the side effects listed in the manual are aggravated, or if you notice any other side effects,not specified in the manual, inform the doctor about it.

Overdose:

Symptoms of vitamin hypervitaminosis D₃:

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

later - pain in the bones, clouding of urine (the appearance of hyaline cylinders, proteinuria, leukocyturia in the urine), increased blood pressure, pruritus, photosensitivity of the eyes, congestion hyperemia, arrhythmia, drowsiness, myalgia, nausea, vomiting, pancreatitis, gasgralgia, weight loss, rarely - psychosis (changes in the psyche) and mood changes.

Symptoms of chronic vitamin intoxication 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 hyperphosphaemia), impaired growth in children (prolonged use at a dose of 1800 IU / day).

Treatment: cancellation of the drug, a diet low in calcium, consumption of large amounts of fluid, the appointment of glucocorticosteroids, in severe cases, intravenous injection of 0.9% sodium chloride solution, furosemide, electrolytes, calcitonin, hemodialysis. 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:

The risk of hypercalcemia increases thiazide diuretics.

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).

Under the influence of barbiturates (including phenobarbital), phenytoin and irimidone, the demand for colcalciferol can significantly increase (increase the metabolic rate).

Long-term therapy against the background of simultaneous use of aluminum and magnesium-containing antacids increases their concentration in the blood and the risk of intoxication (especially in the presence of chronic renal failure).

Calcitonin, bisphosphonates, plikamycin, gallium nitrate and glucocorticosteroids reduce the effect of the drug.

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

Increases the absorption of phosphorus-containing drugs and the risk of 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 D₃ increases the risk of hypervitaminosis.

Concomitant use of benzodiazepines increases the risk of hypercalcemia. Isoniazid and rifampicin can reduce the effect of the drug because of the increased rate of biotransformation.

Does not interact with food.

Special instructions:

Apply the concentration of calcium in blood and urine under careful medical supervision (especially when combined with thiazide diuretics).

In case of prophylactic use, it is necessary to bear in mind the possibility of overdose, especially in children (do not prescribe more than 400,000-600,000 ME in year).Long-term use in high doses leads to chronic hypervitaminosis D₃.

It should be borne in mind that the sensitivity to vitamin D₃ in different patients is individual and in a number of patients the administration of even therapeutic doses can cause hypervitaminosis.

Sensitivity of newborns to vitamin D₃ may be different, some of them may be sensitive even to very low doses. Children receiving vitamin D₃ for a long period of time, the risk of growth retardation increases.

For the prevention of hypovitaminosis D₃ most preferably a balanced diet.

Newborns who are breastfed, especially those born to mothers with dark skin and / or who have insufficient insolation, have a high risk of vitamin deficiency D₃.

In the elderly, the need for a vitamin D₃ may increase due to decreased absorption of the vitamin D₃, reduce the ability of the skin to synthesize provitamin D₃, a decrease in the time of insolation, an increase in the incidence of renal failure.

Since with pseudohypoparathyroidism there can be phases of normal sensitivity to vitamin D₃, it is necessary to adjust the dose of the drug.

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:

Solution for oral administration in oil 20000 IU / ml.

Packaging:To 20, 25, 30 and 50 ml in bottles of dark glass. For 10, 15, 30 and 50 ml in glass bottles, ukuporennyh lids-droppers or caps screwed with stoppers, droppers. Each bottle, together with the instructions for use, is placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

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

Terms of leave from pharmacies:Without recipe

Registration number:LP-001633

Date of registration:06.04.2012

Expiration Date:06.04.2017

The owner of the registration certificate:PHARMACEUTICAL FACTORY of St. Petersburg, JSC PHARMACEUTICAL FACTORY of St. Petersburg, JSC Russia

Manufacturer: & nbsp

Pharmaceutical factory of St. Petersburg, JSC Russia

Information update date: & nbsp21.02.2017

Illustrated instructions

Instructions

Vitamin D3 (Vitamin D3)