Minisan Vitamin D3, drops, 10ml

Product description

dietary supplements. It is not a medicinal product

Composition

Active ingredient:

colecalciferol (vit. D3)200,000 IU;

Auxiliary substances:

medium-cap triglycerides up to 1 ml

Pharmacological action

Minisan Vitamin D3-a remedy that makes up for vitamin D3 deficiency. Participates in the regulation of calcium-phosphorus metabolism, enhances the absorption of calcium and phosphates in the intestine (by increasing the permeability of cellular and mitochondrial membranes of the intestinal epithelium) and their reabsorption in the renal tubules; promotes bone mineralization, the formation of the bone skeleton and teeth in children, enhances the ossification process, 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 partially to albumins. It accumulates in the liver, bones, skeletal muscles, kidneys, adrenal glands, myocardium, and adipose tissue. The time to reach Cmax in tissues is 4-5 hours, then the concentration of colecalciferol decreases slightly, remaining at a constant level for a long time. In the form of polar metabolites, it is localized mainly in the membranes of cells, microsomes, mitochondria and nuclei. Penetrates the placental barrier, is excreted in breast milk. It is deposited in the liver.

It is metabolized in the liver and kidneys: in the liver it is converted to the inactive metabolite calcifediol (25-dihydrocolecalciferol), in the kidneys it is converted from calcifediol to the active metabolite calcitriol (1,25-dihydroxycolecalciferol) and the inactive metabolite 24,25-dihydroxycolecalciferol. Undergoes intestinal-hepatic recirculation.

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

Indications

• prevention and treatment of rickets;
• prevention of deficiency of vitamin D3 at high-risk groups (malabsorption, chronic diseases of the small intestine, biliary cirrhosis, a condition after resection of the stomach and/or small intestine);
• maintenance therapy of osteoporosis (of various origins);
• treatment of osteomalacia (in the background of disorders of mineral metabolism in patients over 45 years of age, prolonged immobilization in the case of injuries, compliance sheet with the refusal of milk and dairy products);
• the treatment of hypoparathyroidism and pseudohypoparathyroidism.

Contraindications

• hypercalcemia;
• hypervitaminosis D3;
• renal osteodystrophy with hyperphosphatemia;
• calcium nephrourolithiasis;
• hypersensitivity (including with thyrotoxicosis).

With caution:  atherosclerosis, heart failure, renal failure, pulmonary tuberculosis (active form), sarcoidosis or other granulomatoses, hyperphosphatemia, phosphate nephrourolithiasis, organic heart damage, acute and chronic liver and kidney diseases, gastrointestinal diseases, gastric and duodenal ulcers, pregnancy, lactation, hypothyroidism.

Side effects

Allergic reactions, hypercalcemia, hypercalciuria, decreased appetite, polyuria, constipation, flatulence, nausea, abdominal pain, headache, myalgia, arthralgia, increased blood pressure, arrhythmia, impaired renal function, exacerbation of tuberculosis in the lungs.

Interaction

Thiazide diuretics increase the risk of hypercalcemia.

With D3 hypervitaminosis, the effect of cardiac glycosides may increase and the risk of arrhythmia may increase due to the development of hypercalcemia (monitoring the concentration of calcium in the blood, electrocardiograms, and dose adjustment of cardiac glycoside are advisable).

Under the influence of barbiturates (including phenobarbital), phenytoin and primidone, the need for colecalciferol can significantly increase (increase the metabolic rate).

Long-term therapy with 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, plicamycin, gallium nitrate and corticosteroids reduce the effect of the drug.

Colestyramine, 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 phosphorous-containing drugs and the risk of hyperphosphatemia.

When used concomitantly with sodium fluoride, the interval between use should be at least 2 hours; with oral forms of getracyclinone, at least 3 hours.

Concomitant use with other vitamin D3 analogues increases the risk of hypervitaminosis.

Concomitant use of benzodiazepines increases the risk of hypercalcemia.

Isoniazid and rifamiicin can reduce the effect of the drug due to an increase in the rate of biotransformation.

Does not interact with food.

How to take, course of use and dosage

Dosage from vials that are not equipped with droppers should be carried out using an eye pipette. 1 drop from an eye pipette or a tube / dropper cap contains 100IU of vigamine D3.

The solution for oral use in oil is given in a spoonful of milk or other liquid.

Prevention of rickets:  full-term healthy children Vitamin D3 is prescribed from the second week of life for 1 drop (about 100 IU) daily. Preterm children are prescribed 2 drops of Vitamin D3 (about 200 IU) daily from the 2nd week of life. The drug is prescribed during the first and second year of life, especially in winter.

For the treatment of rickets:  prescribe from 2 to 8 drops of Vitamin D3 (about 200-800 ME)/day. Treatment is continued for a year.

Prevention of the risk of diseases associated with vitamin D3 deficiency: 1-2 drops of Vitamin D3 (about 100-200 IU)/day.

Prevention of vitamin D3 deficiency in malabsorption syndrome:  5 to 8 drops of Vitamin D3 (about 500-800 IU)/day.

Supportive therapy for osteoporosis:  from 2 to 5 drops of Vitamin D3 (about 200-500 IU)/day.

Treatment of osteomalacia caused by vitamin D3 deficiency:  from 2 to 8 drops of Vitamin (about 200-800 IU)/day. Treatment is continued for a year.

Treatment of hypoparathyroidism and pseudohypoparathyroidism:  depending on the concentration of calcium in plasma,16 to 32 drops of Vitamin D3 are prescribed (about 1600-3200 IU)/day. If a higher dose is required, then it is recommended to take drugs with a higher dosage. The blood calcium concentration should be checked for 4-6 weeks, then every 3-6 months, and the dose adjusted according to the normal blood calcium content.

Overdose

Symptoms of hypervitaminosis of vitamin D3:

• early (due to hypercalcemia), constipation or diarrhea, dryness of the mucous membrane of the mouth, headache, thirst, pollakiuria, nocturia, polyuria, anorexia, metallic taste in mouth, nausea, vomiting, unusual tiredness, weakness, adynamia, hypercalcaemia, hypercalciuria, dehydration;
• late – bone pain, cloudy urine (appearing in the urine hyaline casts, proteinuria, leukocyturia). increased blood pressure, pruritus, photosensitivity of the eyes, conjunctival hyperemia, arrhythmia, drowsiness, myalgia, nausea, vomiting, pancreatitis, gastralgia. weight loss, rarely-psychosis (mental changes) and mood changes.

Symptoms of chronic vitamin D3 intoxication (when taken for several weeks or months for adults in 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 of children (these effects most often occur when hypercalcemia is combined with hyperphosphaemia), growth disorders in children (long-term use at a dose of 1800 IU / day).

Treatment:  discontinuation of the drug, diet with low calcium content, consumption of large amounts of fluids, use of corticosteroids, in severe cases, intravenous use of 0.9% sodium chloride solution, furosemide, electrolytes, calcitonin, hemodialysis. The specific antidote is unknown.

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

Form of production

Solution for oral use

Storage conditions

Store in a dry place, protected from light, at a temperature not exceeding 25 °C.

Shelf life

2 years

Conditions of release from pharmacies

Without a prescription

Dosage form

Drops for oral use

Purpose

Adult