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For sale to the public as a biologically active food supplement - an additional source of vitamin D.
E967, E420, E463, E470, cholecalciferol, E307, palm oil, E1450, sucrose, E301, E551, food aromatisers raspberry, peach.
Colecalciferol is marketed under different brands and generic names, and comes in different dosage forms:
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Dosage and Administration
Vigantol drug is taken orally with milk or other liquid.
Prevention of rickets: Vigantol® full-term healthy children are prescribed from 2 weeks of life to 1 drop (about 667 IU of vitamin D3) daily. Premature babies are prescribed from 2 weeks of life to 2 drops (1334 IU of vitamin D3) daily. The drug should be taken during the first and second year of life, especially in the winter months.
Treatment of rickets: prescribe 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 1334-5336 IU of vitamin D3) per day. Treatment should be continued for 1 year.
Supportive therapy for osteoporosis: 2-5 drops of Vigantol (about 1334-3335 ME of vitamin D3) per day.
Treatment of hypoparathyroidism and pseudohypoparathyroidism: depending on the plasma calcium concentration, 15-30 drops (about 10,005-20,010 IU of vitamin D3) are prescribed per day. The calcium concentration in the blood should be checked within 4-6 weeks, then every 3-6 months, and the dose should be adjusted in accordance with the calcium content in the blood.
On the part of the digestive system: constipation, flatulence, nausea, abdominal pain, diarrhea, loss of appetite.
On the part of the metabolism: hypercalcemia and hypercalciuria in the case of taking the drug for a long time in high doses, polyuria.
From the musculoskeletal system: myalgia, arthralgia.
Since the cardiovascular system: increased blood pressure, arrhythmias.
Allergic reactions: itching, rash, urticaria.
Other: headache, impaired renal function, exacerbation of the tuberculous process in the lungs.
- calcium nephrourolithiasis;
- thyrotoxicosis (probability of hypersensitivity);
- renal osteodystrophy with hyperphosphatemia;
- hypervitaminosis D;
- Hypersensitivity to the drug.
The drug should be prescribed with caution in atherosclerosis, heart failure, renal failure, sarcoidosis or other granulomatosis, hyperphosphatemia, phosphate nephrourolithiasis (including history), organic lesions of the heart, acute and chronic diseases of the liver and kidneys, diseases of the gastrointestinal tract (in t of gastric ulcer and duodenal ulcer), with hypothyroidism, during pregnancy and during breastfeeding, while taking additional amounts of vitamin D3 (for example, as part of other drugs).
Phenytoin, primidone and barbiturate drugs increase the need for vitamin D3 due to an increase in the biotransformation rate.
Long-term therapy against the background of the 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, pamidronic acid), plicamycin reduce the effect.
Kolestiramin, Kolestipol reduce the absorption of fat-soluble vitamins from the gastrointestinal tract and require an increase in their dose.
Increases the absorption of phosphorus-containing drugs and the risk of hyperphosphatemia.
With simultaneous use of sodium fluoride, the interval between intake should be at least 2 hours; with oral forms of tetracyclines - at least 3 hours.
With concomitant therapy of 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 indicators of calcium, ECG, and adjust the dose of cardiac glycosides.
Concomitant benzodiazepine therapy increases the risk of hypercalcemia.
Vitamin D3 can be combined with metabolites or analogues of vitamin D only in exceptional cases and under the control of the level of calcium in the blood serum.
Thiazide diuretics may reduce urinary calcium excretion and, accordingly, increase the risk of hypercalcemia. In such patients, it is necessary to continuously 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.
Pregnancy and Lactation
Use of the drug VIGANTOL® during pregnancy and breastfeeding
With care it is necessary to apply Vigantol® during pregnancy and in the period of a lactation (breastfeeding).
During pregnancy and during breastfeeding, adequate intake of vitamin D3 is required.
In case of overdose, hypercalcemia and transplacental penetration of vitamin D3 metabolites into the fetus may occur, which can lead to teratogenic effects: delayed mental and physical development of the fetus, special forms of aortic stenosis.
Vitamin D3 and its metabolites are excreted in breast milk.
When pseudohypoparathyroidism is necessary to control the presence of signs of intoxication. Since with pseudohypoparathyroidism, there may be phases of normal sensitivity to vitamin D, it is necessary to adjust the dose of the drug. When pseudohypoparathyroidism, which occurred after surgical treatment of the thyroid gland, it is necessary to discontinue use of the drug as the parathyroid glands recover to prevent vitamin D intoxication.
Influence on ability to drive motor transport and control mechanisms
Studies on the effect on the ability to drive a vehicle and work with mechanisms were not conducted.
The symptoms of hypervitaminosis D3: early (due to hypercalcemia) - constipation or diarrhea, dryness of the oral mucosa, headache, thirst, pollakiuria, nocturia, polyuria, anorexia, metallic taste in the mouth, nausea, vomiting, unusual tiredness, fatigue, weakness, dehydration, hypercalcemia, hypercalciuria, an increase in the blood plasma concentration of 25-dihydrocolecalciferol; late - pain in bones, turbidity of urine (appearance of hyaline cylinders in the urine, proteinuria, leukocyturia), increased blood pressure, pruritus, photosensitivity of the eye, 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 overdose of vitamin D3 (when taken for several weeks or months for adults in doses of 20-60 thousand IU / day., For children - 2-4 thousand IU / day.): Calcification of soft tissues, kidneys, lungs, blood vessels, increased blood pressure, renal and heart failure (these effects most often occur when hyperphosphatemia is added to hypercalcemia), growth impairment in children (long-term use at a dose of 1.8 IU / day).
Treatment: in acute or chronic overdose, measures should be taken to treat developing hypercalcemia. Depending on the severity of hypercalcemia, the following measures are used: drug withdrawal, a diet low in calcium, consumption of large quantities of fluid, administration of GCS, vitamin E, ascorbic acid, retinol, thiamine, pantothenic acid, riboflavin; in severe cases - IV the introduction of a 0.9% solution of sodium chloride, furosemide, electrolytes, hemodialysis, the introduction of calcitonin. There is no specific antidote. To exclude overdose in some cases, it is recommended to determine the concentration of calcium in the blood.
Before use, it is recommended to consult a doctor.
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