Vigantol, drops 0.5 mg/ml 10 ml

The purpose of this drug is to regulate calcium and phosphorus metabolism. At the same time vitamin D3 deficiency is compensated, absorption of calcium in the gastrointestinal tract and reabsorption of phosphate in the kidneys is increased. Vigantol also contributes to mineralization of bones, which is necessary for complete functioning of parathyroid glands.

The drug is absorbed from the gastrointestinal tract. Inside the body, the active substance binds with α2-globulins, some part with albumin.

Calciferol accumulation occurs in liver, bone and fat tissue, skeletal muscles, adrenal glands and kidneys, myocardium. Maximum concentration of the substance in the tissue is reached after 4-5 hours, then it decreases slightly, but still remains at the required level for a long time.

As a result of biotransformation in the liver and kidneys are formed inactive metabolites -calciferol and dihydroxycalciferol, the active metabolite calcitriol.

< br>.

Indications

The main indications for the use of Vigantol are:

Active ingredient

Composition

Active ingredient:

colecalciferol 500 mcg (20,000 IU)

Auxiliary substances:

Triglycerides medium-chain – 939.5 mg.

How to take, the dosage

Vigantol® is taken orally with milk or other liquids.

Prevention of rickets: Healthy premature infants are prescribed Vigantol® 1 drop (about 667 ME of vitamin D3) daily from the second week of life. Premature babies are prescribed 2 drops (1,334 ME of vitamin D3) daily from the 2nd week of life. The drug should be taken during the first and second years of life, especially during the winter months.

The treatment of rickets: 2-8 drops of Vigantol (about 1,334 to 5,336 ME of vitamin D3) per day are prescribed. The treatment should be continued for 1 year.
Prevention of the risk of diseases associated with vitamin D3 insufficiency: 1-2 drops (about 667-1334 ME of vitamin D3) per day.
Prevention of vitamin D3 insufficiency in malabsorption syndrome: 5-8 drops (about 3335-5336 ME of vitamin D3) per day.

Treatment of osteomalacia caused by vitamin D3 insufficiency: 2-8 drops (about 1334-5336 ME of vitamin D3) per day. Treatment should be continued for 1 year.

Osteoporosis maintenance therapy: 2-5 drops of Vigantol (about 1334-3335 ME of vitamin D3) per day.

The treatment of hypoparathyroidism and pseudohypoparathyroidism: depending on plasma calcium concentration 15-30 drops (about 10,005-20,010 ME of vitamin D3) per day are prescribed. Blood calcium concentration should be checked for 4-6 weeks, then every 3-6 months, and the dose should be adjusted according to blood calcium content.

Interaction

Phenytoin, primidone and drugs of the group of barbiturates increase the need for vitamin D3 because of the increased rate of biotransformation.
Long-term therapy with simultaneous use of antacids containing aluminum and magnesium ions increases their concentration in the blood and the risk of intoxication (especially in the presence of chronic renal failure).

Calcitonin, bisphosphonates (including etidronic, pamidronic acid), plikamycin reduce the effect.

Colestyramine and colestipol 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 hours; with oral forms of tetracyclines, at least 3 hours.

Concomitant therapy with GCS may decrease the effectiveness of the drug.

Concomitant therapy with cardiac glycosides may increase their toxic potential due to development of hypercalcemia. In these patients, calcium levels and ECG should be monitored, and doses of cardiac glycosides should be adjusted.

The concomitant therapy with benzodiazepine derivatives increases the risk of hypercalcemia.

Vitamin D3 may be combined with vitamin D metabolites or analogues only in exceptional cases and under control of serum calcium levels.

Thiazide diuretics can decrease urinary calcium excretion and, accordingly, increase the risk of hypercalcemia. Constant monitoring of calcium concentration in blood is necessary in these patients.

Rifampicin and isoniazid can decrease the effect of the drug due to increased biotransformation rate.

Vigantol® does not interact with food.

Special Instructions

In pseudohypoparathyroidism it is necessary to monitor for signs of intoxication. Since in pseudohypoparathyroidism there may be phases of normal sensitivity to vitamin D, it is necessary to adjust the dose of the drug.

In pseudohypoparathyroidism following surgical treatment of the thyroid gland, the drug should be discontinued as the parathyroid glands recover to prevent vitamin D intoxication.

Impact on driving and operating machinery

There have been no studies on the effect on driving and operating machinery.

Contraindications

With caution, the drug should be prescribed in atherosclerosis, heart failure, renal failure, sarcoidosis or other granulomatosis, hyperphosphatemia, phosphatic nephrolithiasis (including history ofIncluding in anamnesis), organic lesions of heart, acute and chronic liver and kidney diseases, gastrointestinal diseases (including gastric and duodenal ulcer), hypothyroidism, pregnancy and during breast-feeding, when taking additional amounts of vitamin D3 (for example, in other preparations).

Side effects

Digestive system disorders: constipation, flatulence, nausea, abdominal pain, diarrhea, decreased appetite.

Metabolism disorders: hypercalcemia and hypercalciuria in case of taking the drug in high doses for a long time, polyuria.

Muscular system disorders: myalgia, arthralgia.

Cardiovascular system: increase in BP, arrhythmias.

Allergic reactions: itching, rash, urticaria.

Others: headache, impaired renal function, exacerbation of tuberculosis in the lungs.

Overdose

Symptoms of hypervitaminosis D3: Early (due to hypercalcemia) – constipation or diarrhea, dry oral mucosa, headache, thirst, pollakiuria, nycturia, polyuria, anorexia, metallic taste in the mouth, nausea, vomiting, unusual fatigue, general weakness, adynamia, dehydration, hypercalcemia, hypercalciuria, increased plasma concentration of 25-dihydrocolecalciferol; Later – bone pain, turbidity of urine (appearance of hyaline cylinders in urine, proteinuria, leukocyturia), increased BP, skin itching, photosensitivity of eyes, conjunctival hyperemia, arrhythmia, somnolence, myalgia, nausea vomiting, pancreatitis, gastralgia, weight loss; rarely – mental changes (up to development of psychosis) and mood.

The symptoms of chronic overdose of vitamin D3 (when taken for several weeks or months for adults at doses of 20-60 thousand IU/day, For children – 2-4 thousand IU/day): calcinosis of soft tissues, kidneys, lungs, blood vessels, increased BP, renal and heart failure (these effects most often occur in conjunction with hypercalcemia hyperphosphatemia), growth disorders in children (prolonged use at a dose of 1.8 IU/day).

Treatment: in acute or chronic overdose it is necessary to carry out measures to treat the developing hypercalcemia. Depending on severity of hypercalcemia the following measures are used: discontinuation of the preparation, diet with low content of calcium, intake of large amounts of fluids, prescription of GCS, vitamin E, ascorbic acid, retinol, thiamin, pantothenic acid, riboflavin, in severe cases – intravenous injection of 0.9% solution of sodium chloride, furosemide, electrolytes, hemodialysis, calcitonin injection. There is no specific antidote. In order to exclude overdose in a number of cases determination of calcium concentration in blood is recommended.

Similarities