Vigantol
Vigantol: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. In case of impaired renal function
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Vigantol
ATX code: A11CC05
Active ingredient: colecalciferol (colecalciferol)
Manufacturer: Merck KGaA (Germany)
Description and photo update: 2019-14-08
Vigantol is a vitamin preparation that replenishes vitamin D3 deficiency, regulates the exchange of phosphorus and calcium.
Release form and composition
The dosage form of Vigantol is an oily solution for oral administration: viscous, transparent, slightly yellowish (10 ml each in dark glass bottles with a dropper stopper, 1 bottle in a cardboard box).
Active ingredient: colecalciferol, in 1 ml - 20,000 IU (500 μg).
Additional components: medium chain triglycerides.
Pharmacological properties
Pharmacodynamics
Colecalciferol (vitamin D 3) is an anti- rachitic agent that replenishes vitamin D 3 deficiency. It has the following effects on the body:
- provides normal calcium-phosphorus metabolism;
- stimulates the processes of phosphate reabsorption in the kidneys and calcium absorption in the intestine;
- promotes bone mineralization;
- ensures the normal functioning of the parathyroid glands.
A consequence of vitamin D 3 and / or calcium deficiency is parathyroid hormone hypersecretion. As a result of secondary hyperparathyroidism, bone remodeling is enhanced, causing fragility of bones and contributing to their fractures. In the case of using vitamin D 3 and calcium in the recommended doses, the secretion of parathyroid hormone decreases.
Pharmacokinetics
When taken orally, colecalciferol is almost completely absorbed in the small intestine (80%). The time to reach the maximum concentration in the tissues is 4–5 hours, after which the content of the substance decreases slightly and remains at a constant level for a long time.
By binding to colecalciferol-binding protein in the blood plasma, colecalciferol is transported to the liver, where, due to microsomal hydroxylation, an inactive metabolite 25-hydroxycolecalciferol (calcifediol) is formed. The level of calcifediol circulating in the blood reflects the level of colecalciferol in the body.
Calcifediol entering the kidneys undergoes repeated hydroxylation, which results in the formation of an active metabolite 1,25-dihydroxycolecalciferol (calcitriol). Both metabolites and vitamin D 3 itself accumulate in adipose and muscle tissues, and the concentration can be relatively constant over several months. As a result of taking high doses of Vigantol, the serum calcifediol content can remain elevated for several months. In case of an overdose of colecalciferol, hypercalcemia may persist for several weeks.
Before elimination from the body, calcitriol is hydroxylated. The bulk of vitamin D 3 and its sulfate and hydroxylated derivatives are excreted in the bile (feces). At least 2% of vitamin D 3 is excreted in the urine. Colecalciferol crosses the placental barrier and is excreted in breast milk.
Indications for use
- Prevention of vitamin D deficiency in high-risk patients (chronic diseases of the small intestine, condition after resection of the stomach and / or small intestine, biliary cirrhosis of the liver, malabsorption);
- Treatment and prevention of rickets;
- Supportive therapy for osteoporosis of various origins;
- Treatment of hypoparathyroidism and pseudohypoparathyroidism;
- Treatment of osteomalacia (due to adherence to diets with refusal of dairy products, prolonged immobilization due to injuries, disorders of mineral metabolism in people over 45).
Contraindications
Absolute:
- Calcium nephrourolithiasis;
- Hypercalciuria;
- Hypercalcemia;
- Hypervitaminosis D;
- Renal osteodystrophy with hyperphosphatemia;
- Thyrotoxicosis;
- Hypersensitivity to the drug.
Relative (due to the high risk of complications, special care should be taken):
- Atherosclerosis;
- Heart failure;
- Organic heart damage;
- Acute and chronic kidney and liver diseases;
- Renal failure;
- Diseases of the gastrointestinal tract, including gastric ulcer and 12 duodenal ulcer;
- Sarcoidosis or other granulomatosis;
- Hyperphosphatemia;
- Phosphate nephrourolithiasis, including a history;
- Hypothyroidism;
- Pregnancy and lactation;
- Additional intake of vitamin D3, including as part of other drugs.
Instructions for the use of Vigantol: method and dosage
According to the instructions, Vigantol should be taken orally with milk or any other liquid.
Recommended doses depending on indications:
- Prevention of rickets: healthy full-term babies - 1 drop daily (starting from 2 weeks of age); premature babies - 2 drops daily (starting from 2 weeks of age). Vigantol should be taken during the 1st and 2nd year of life, especially in the winter months;
- Treatment of rickets: 2-8 drops per day, duration of admission - 1 year;
- Prevention of the development of diseases associated with vitamin D3 deficiency: 1-2 drops per day;
- Prevention of vitamin D3 deficiency in patients with malabsorption syndrome: 5-8 drops per day;
- Maintenance therapy of osteoporosis: 2-5 drops per day;
- Treatment of osteomalacia due to vitamin D3 deficiency: 2-8 drops per day, duration of therapy - 1 year;
- Treatment of hypoparathyroidism and pseudohypoparathyroidism: 15-30 drops per day. The concentration of calcium in the blood should be checked regularly during the first 4-6 weeks of treatment, then every 3-6 months. In the future, the dose can be adjusted in accordance with the calcium content in the blood.
Side effects
- Digestive system: abdominal pain, nausea, diarrhea or constipation, decreased appetite, flatulence;
- Cardiovascular system: arrhythmias, increased blood pressure;
- Musculoskeletal system: arthralgia, myalgia;
- Metabolism: polyuria; when taken in high doses for a long time - hypercalciuria and hypercalcemia;
- Allergic reactions: rash, hives, itching;
- Others: impaired renal function, headache, exacerbation of the tuberculous process in the lungs.
Overdose
Acute or chronic overdose can cause hypercalcemia. In the case of a persistent nature, hypercalcemia is a potential life threat. Symptoms are general and include thirst, cardiac arrhythmias, constipation, nausea, vomiting, dehydration, polyuria, polydipsia, hypercalciuria with kidney stones, nephrocalcinosis, adynamia, muscle weakness, and confusion. In chronic overdose, calcium deposition in tissues and blood vessels may occur.
Daily doses less than 500 IU
In case of prolonged overdose of vitamin D 3, hypercalcemia and hypercalciuria may occur. With significant excessive use over a long period, the development of calcification of parenchymal organs is possible.
Daily doses over 500 IU
Colecalciferol (vitamin D 3) and ergocalciferol (vitamin D 2) have a relatively low therapeutic index. With normal function of the parathyroid glands in adult patients, the threshold of intoxication for vitamin D 3 is 40,000 to 100,000 IU per day for 1-2 months. There is a risk of sensitivity to lower concentrations in newborns or young children. Patients should be aware that Vigantol is not recommended for use without medical supervision.
In case of an overdose, the level of phosphorus in urine and blood serum increases, hypercalcemic syndrome develops, followed by calcium deposition in tissues, mainly in the vessels and kidneys (nephrocalcinosis and urolithiasis).
Intoxication symptoms: at the first stage - nausea, vomiting, diarrhea; further - constipation, loss of appetite, headache, weakness, pain in joints, muscles, muscle weakness, constant drowsiness, azotemia, polydipsia, polyuria; at the final stage - dehydration of the body. Typical biochemical data contain signs of hypercalcemia, hypercalciuria, an increase in the concentration of 25-hydroxycolecalciferol in the blood serum.
special instructions
During the treatment period for pseudohypoparathyroidism, the patient's condition should be monitored for signs of intoxication. Patients with this condition may require dose adjustment. In case of pseudohypoparathyroidism that develops after surgical treatment of the thyroid gland, to prevent vitamin D intoxication, Vigantol should be discontinued as the parathyroid glands recover.
Studies on the effect of Vigantol on the reaction rate and the ability to concentrate have not been conducted.
An adequate intake of vitamin D3 is required during pregnancy and lactation. In case of an overdose, hypercalcemia and transplacental penetration of vitamin D3 metabolites into the fetus are possible, which is fraught with teratogenic effects, manifested by a delay in the physical and mental development of the fetus, and special forms of aortic stenosis.
Application during pregnancy and lactation
During pregnancy and breastfeeding, it is necessary to ensure an adequate level of vitamin D 3 intake.
During pregnancy, it is recommended to avoid exceeding the indicated doses, since hypercalcemia can lead to a delay in the physical and mental development of the fetus, special forms of aortic stenosis and retinopathy in children.
Daily doses less than 500 IU
When using Vigantol in the indicated doses, there is no data on the risk of side effects.
Daily doses over 500 IU
During pregnancy, the drug should be used only when clearly necessary and only in those doses that are required to replenish the lack of vitamin D 3.
The active substance and its metabolites are excreted in breast milk. Overdose cases in newborns during breastfeeding have not been recorded.
With impaired renal function
When using Vigantol for the treatment of patients with renal insufficiency, it is necessary to control the effect of the drug on the metabolism of phosphates and calcium.
Drug interactions
- Preparations of the barbiturate group, primidone, phenytoin: the rate of biotransformation of vitamin D3 increases, which increases the need for it;
- Bisphosphonates (including pamidronic and etidronic acids), calcitonin, plikamycin: the effectiveness of Vigantol decreases;
- Magnesium and aluminum-containing antacids: their concentration in the blood increases and, as a result, the risk of intoxication, especially in patients with chronic renal failure;
- Colestipol, cholestyramine: absorption of fat-soluble vitamins decreases (an increase in their dose is required);
- Glucocorticosteroids, rifampicin, isoniazid: the effectiveness of Vigantol decreases;
- Benzodiazepine derivatives: the risk of developing hypercalcemia increases;
- Cardiac glycosides: their toxic potential increases (it is necessary to adjust their dose, monitor the electrocardiogram and calcium levels);
- Phosphorus-containing drugs: their absorption increases, the risk of hyperphosphatemia increases;
- Thiazide diuretics: the excretion of calcium in the urine decreases, the likelihood of developing hypercalcemia increases (the calcium content in the blood should be monitored).
Vigantol does not interact with food. If necessary, it can be combined with analogues or metabolites of vitamin D, but only in exceptional cases and under close monitoring of the level of calcium in the blood serum.
In the case of concomitant administration of oral tetracyclines, at least 3-hour intervals should be observed between doses of drugs. With the simultaneous use of sodium fluoride, the interval between doses should not be less than 2 hours.
Analogs
Vigantol's analogues are: Vitamin D3, Vitamin D3 BON, Aquadetrim, Videhol, Colecalciferol, Cholecalciferol.
Terms and conditions of storage
Store at a temperature of 15-25 ºС, protected from light, out of reach of children.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Vigantol
Reviews of Vigantol from parents of young children indicate that when taking the drug for 1-2 years, no pathological changes are detected in the bone structure. There are practically no reports of the development of side effects in newborns and young children.
The price of Vigantol in pharmacies
The approximate price for Vigantol is 210 rubles (0.5 mg / ml solution, 10 ml in a bottle).
Maria Kulkes Medical journalist About the author
Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
