Vigantol oil solution for oral use 0.5mg/ml vials, 10ml

Composition

Active ingredient:

colecalciferol 500 mcg (20,000 IU)

Auxiliary substances:

medium-chain triglycerides – 939.5 mg

Pharmacological action

The purpose of this drug is to regulate the exchange of calcium and phosphorus. At the same time, vitamin D3 deficiency is replenished, calcium absorption in the gastrointestinal tract and reabsorption of phosphates in the kidneys are enhanced. Vigantol also promotes bone mineralization, which is necessary for the full functioning of the parathyroid glands.

Absorption of the drug occurs from the gastrointestinal tract. Inside the body, the Active ingredient binds to α2-globulins, some of them to albumins.

Colecalciferol accumulates in the liver, bone and adipose tissue, skeletal muscles, adrenal glands and kidneys, and the myocardium. Reaching the maximum concentration of the substance in the tissues is noted after 4-5 hours, then it decreases slightly, but still remains at the required level for a long time.

Colecalciferol has been found to penetrate the placental barrier and is also excreted in breast milk.

As a result of biotransformation, inactive metabolites are formed in the liver and kidneys –calcifediol and dihydroxycolecalciferol, the active metabolite calcitriol.

Indications

The main indications for the use of Vigantol are:

• rickets;
• spasmophilia;
• osteomalacia.

Contraindications

• hypercalcemia;
• hypercalciuria;
• calcium nephrourolithiasis;
• thyrotoxicosis (possible hypersensitivity);
• renal osteodystrophy with hyperphosphatemia;
• hypervitaminosis D;
• hypersensitivity to the components of the drug.

With caution, the drug should be prescribed for atherosclerosis, heart failure, renal failure, sarcoidosis or other granulomatosis, hyperphosphatemia, phosphate nephrourolithiasis (including in the anamnesis), organic heart damage, acute and chronic liver and kidney diseases, gastrointestinal diseases (including gastric and duodenal ulcers), hypothyroidism, pregnancy and lactation, when taking additional amounts of vitamin D3 (for example, as part of other medications).

Side effects

From the digestive system: constipation, flatulence, nausea, abdominal pain, diarrhea, decreased appetite.

From the side of metabolism: hypercalcemia and hypercalciuria in case of taking the drug for a long time in high doses, polyuria.

Musculoskeletal disorders: myalgia, arthralgia.

From the cardiovascular system: increased blood pressure, arrhythmias.

Allergic reactions: pruritus, rash, urticaria.

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

Interaction

Phenytoin, primidone and barbiturate preparations increase the need for vitamin D3 due to an increase in the 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 ethidronic acid, pamidronic acid), plikamycin reduce the effect.

Colestyramine and colestipol reduce the absorption of fat-soluble vitamins from 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 tetracyclines – at least 3 hours.

Concomitant therapy with corticosteroids may reduce the effectiveness of the drug.

Concomitant therapy with cardiac glycosides may increase their toxic potential due to the development of hypercalcemia. In such patients, it is necessary to monitor the level of calcium, ECG, and adjust the dose of cardiac glycosides.

Concomitant treatment with benzodiazepine derivatives increases the risk of hypercalcemia.

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

Thiazide diuretics may reduce urinary calcium excretion and, consequently, increase the risk of hypercalcemia. In such patients, it is necessary to constantly monitor the concentration of calcium in the blood.

Rifampicin and isoniazid may reduce the effect of the drug due to an increase in the rate of biotransformation.

Vigantol® does not interact with food.

How to take, course of use and dosage

The drug Vigantol is taken orally with milk or other liquid.

Prevention of rickets: full-term healthy children are prescribed Vigantol® from 2 weeks of life,1 drop (about 667 IU of vitamin D3) daily. Preterm children are prescribed 2 drops (1334 IU of vitamin D3) daily from the 2nd week of life. The drug should be taken during the first and second year of life, especially during the winter months.

Treatment of rickets: assign 2-8 drops of Vigantol (about 1334-5336 IU of vitamin D3) per day. Treatment should be continued for 1 year. Prevention of the risk of diseases associated with vitamin D3 deficiency: 1-2 drops (about 667-1334 IU of vitamin D3) per day. Prevention of vitamin D3 deficiency in malabsorption syndrome: 5-8 drops (about 3335-5336 IU of vitamin D3) per day.

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

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

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

Overdose

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

Symptoms of chronic vitamin D3 overdose (when taken for several weeks or months for adults in doses of 20-60 thousand mg). IU/day, for children – 2-4 thousand rubles. IU / day): calcification of soft tissues, kidneys, lungs, blood vessels, increased blood pressure, renal and heart failure (these effects most often occur when hypercalcemia is combined with hyperphosphatemia), growth disorders in children (long-term use at a dose of 1.8 IU/day).

Treatment: in case of acute or chronic overdose, measures should be taken to treat developing hypercalcemia. Depending on the severity of hypercalcemia, the following measures are used: discontinuation of the drug, diet with a low calcium content, consumption of large amounts of fluids, use of corticosteroids, vitamin E, ascorbic acid, retinol, thiamine, pantothenic acid, riboflavin; in severe cases-intravenous use of 0.9% sodium chloride solution, furosemide, electrolytes, hemodialysis, calcitonin. There is no specific antidote. To avoid overdose, in some cases, it is recommended to determine the concentration of calcium in the blood.

Special instructions

In pseudohypoparathyroidism, it is necessary to monitor the presence of 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.

If pseudohypoparathyroidism occurs after surgical treatment of the thyroid gland, it is necessary to stop using the drug as the parathyroid glands recover to prevent vitamin D intoxication.

Influence on the ability to drive motor vehicles and manage mechanisms

Studies on the effect on the ability to drive a vehicle and work with mechanisms have not been conducted.

Form of production

solution for oral use

Active ingredient

Colecalciferol

Conditions of release from pharmacies

By prescription

Dosage form

solution for oral use

Indications

Osteoporosis, Rickets, Malnutrition