Minisan Vitamin D3, drops, 10 ml

Minisan Vitamin D3 is a remedy to compensate for vitamin D3 deficiency. It participates in the regulation of calcium-phosphorus metabolism, increases the absorption of calcium and phosphate in the intestine (due to increased permeability of cell and mitochondrial membranes of the intestinal epithelium) and their reabsorption in renal tubules; promotes bone mineralization, formation of bone skeleton and teeth in children, increases the ossification process, necessary for normal functioning of parathyroid glands.

Pharmacokinetics

Absorption is fast (in the distal small intestine), enters the lymphatic system, enters the liver and the general bloodstream. In the blood it binds with alpha2-globulins and partially with albumin. It accumulates in the liver, bones, skeletal muscles, kidneys, adrenal glands, myocardium, adipose tissue. Cmax in tissues reaches 4-5 hours, then the concentration of colecalciferol decreases slightly, remaining constant for a long time. In the form of polar metabolites it is localized mainly in cell membranes, microsomes, mitochondria and nuclei. It penetrates the placental barrier and is excreted with breast milk. It is deposited in the liver.

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

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

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Indications

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

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Composition

Active ingredient:

Colocalciferol (Vit. D3)200000 IU;

Excipients:

triglycerides medium-chain up to 1 ml

How to take, the dosage

Dosing from bottles not equipped with droppers must be done using an eye dropper. 1 drop from the eye dropper or cap/top dropper contains 100 ME of vitamin D3.

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

Vitamin D3 is given to healthy, full-term children from the second week of life, 1 drop (about 100 ME) daily. Premature infants are prescribed 2 drops of vitamin D3 (about 200 ME) daily from the second week of life. The drug is prescribed during the first and second years of life, especially in winter.

For the treatment of rickets: 2 to 8 drops of Vitamin D3 (about 200-800 ME)/day. The treatment continues for one year.

Preventing the risk of disease associated with vitamin D3 insufficiency: 1 to 2 drops of vitamin D3 (approximately 100-200 ME)/day.

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

The maintenance therapy of osteoporosis: 2 to 5 drops of Vitamin D3 (about 200-500 ME)/day.

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

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

Interaction

The risk of hypercalcemia is increased by thiazide diuretics.

In hypervitaminosis D3 there may be increased effect of cardiac glycosides and increased risk of arrhythmias due to the development of hypercalcemia (monitoring of blood calcium concentration, electrocardiogram, and correction of cardiac glycoside dose is advisable).

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

Long-term therapy with concomitant use of aluminum- and magnesium-containing antacids increases their concentrations in the blood and the risk of intoxication (especially in the presence of chronic renal failure).

Calcitonin, bisphosphonates, plycamycin, gallium nitrate and GCS reduce the effect of the drug.

Colestyramine, colestipol, and mineral oils decrease gastrointestinal absorption of fat-soluble vitamins and require increasing their dose.

Adds absorption of phosphorus-containing drugs and the risk of hyperphosphatemia.

In concomitant use with sodium fluoride, the interval between doses should be at least 2 h; with oral forms of Hetracycline at least 3 h.

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

The concomitant use of benzodiazepines increases the risk of hypercalcemia.

Isoniazid and rifamycin can decrease the effect of the drug due to increased biotransformation rate.

It does not interact with food.

Contraindications

• hypercalcemia;
• hypervitaminosis D3;
• renal osteodystrophy with hyperphosphatemia;
• calcium nephrourolithiasis;
• high sensitivity (incl.
• dynamic sensitivity (including in thyrotoxicosis).

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

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Overdose

Symptoms of vitamin D3 hypervitaminosis:

• .Early (due to hypercalcemia) – constipation or diarrhea, dry oral mucosa, headache, thirst, pollakiuria, nycturia, polyuria, anorexia, metallic taste in the mouth, nausea, vomiting, extraordinary fatigue, general weakness, adynamic, hypsrcalcemia, hypercalciuria, dehydration;
• late – bone pain, turbidity of the urine (appearance of hyaline cylinders in the urine, proteinuria, leukocyturia). Increased BP, skin itching, photosensitivity of the eyes, conjunctival hyperemia, arrhythmia, somnolence, 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 at doses of 20000-60000 IU/day, children 2000-4000 IU/day):

• calcinosis of soft tissues, kidneys, lungs, blood vessels, arterial hypertension, renal and chronic heart failure up to (these effects most often occur when hypercalcemia hyperphosphaemia is joined with hyperphosphaemia), growth disorder in children (long-term administration at a dose of 1800 IU/day).

Treatment: drug withdrawal, low-calcium diet, large fluid intake, GCS administration, in severe cases intravenous administration of 0.9% sodium chloride solution, furosemide, electrolytes, calcitonin, hemodialysis. The specific antidote is unknown.

To prevent overdose in a number of cases it is recommended to control the concentration of calcium in the blood.