VYHANTOL
Active material: Kolekaltsiferol
When ATH: A11CC05
CCF: Preparation, regulates the exchange of calcium and phosphorus
ICD-10 codes (testimony): E20, E20.1, E55, E55.0, E58, M81.0, M81.1, M81.2, M81.4, M81.8, M82, M83, R29.0
When CSF: 16.04.01.01
Manufacturer: MERCK KGaA (Germany)
Pharmaceutical form, composition and packaging
Oral solution Oil clear, slightly yellowish, Coupling.
| 1 ml | |
| Kolekaltsiferol | 500 g (20 thousand IU) |
Excipients: trigliceridy (939.5 mg).
10 ml – dropper bottle of dark glass (1) – packs cardboard.
Pharmacological action
Preparation, regulates the exchange of calcium and phosphorus. Restores vitamin D deficiency3. Increases the absorption of calcium in the intestine and reabsorption in the renal tubules phosphorus. It promotes the formation of skeleton and teeth in children, preservation of bone structure.
Vitamin D is necessary for normal functioning of the parathyroid glands.
Pharmacokinetics
Absorption
After ingestion absorbed from the distal small intestine.
Distribution
It accumulates in the liver, bones, skeletal muscle, kidney, adrenal glands, miokarde, fat tissue. Cmax in tissues is achieved through 4-5 no.
It penetrates through the placental barrier. Provided with breast milk.
Metabolism
Biotransformed in the liver and kidneys to the active metabolites.
Deduction
Write mainly in the faeces, in minor amounts – urine.
Testimony
- Prevention and treatment of rickets;
- Prevention of vitamin D deficiency in patients at high risk (malabsorption, chronic diseases of the small intestine, biliary cirrhosis, state after gastrectomy and / or small intestine);
- Hypocalcemia;
- Hypocalcemic tetany;
- Osteoporosis (various origins);
- Osteomalacia (Against the backdrop of mineral metabolism in patients over 45 years, prolonged immobilization in case of injury, dieting with the refusal to accept the milk and milk products);
- Treatment of hypoparathyroidism and pseudohypoparathyreosis.
Dosage regimen
The drug is taken orally, required amount of the drug solution is mixed with a spoon of milk or other liquid.
To prevention raxita full-term healthy children Vigantol appoint 1 drop (about 500 ME) daily (take 5 days, then break 2 day) starting from the 2nd month of life during the first and second year of life, excluding the summer months. Premature babies appoint 2 drops. To treatment of rickets appoint 2-8 drops (about 1000-5000 ME)/days from the 10th day for the first 2 months of life, as well as the 5th and 9th months of life, in the second year of life is conducted 1-2 rate during the winter-spring period.
To prevention the risk of disease, related from vitamin D deficiency3 appoint 1-2 drops (about 500-1000 ME)/d (take 5 days, then break 2 day).
To prevention vitamin D deficiency3 the syndrome of malabsorption the drug is prescribed for 4-8 drops (about 3000-5000 ME)/d.
To treatment of osteomalacia, caused by vitamin D deficiency3 Vigantol administered at a dose of 2 to 8 drops (about 1000-5000 ME)/d. Treatment should be continued for 1 year.
As maintenance therapy for osteoporosis appointed 2-4 Drops Vigantola (about 1000-3000 ME)/d.
At the treatment of hypoparathyroidism and pseudohypoparathyreosis depending on the concentration of calcium in plasma administered 15-30 drops Vigantola (about 10 000-20 000 ME)/d. The level of calcium in blood and urine should be monitored for 4-6 weeks, then every 3-6 months and adjust the dose in accordance with normal blood calcium.
Side effect
From the electrolyte metabolism: giperfosfatemiя, hypercalcemia, hypercalciuria.
From the digestive system: anorexia, constipation.
From the urinary system: polyuria, renal failure.
CNS: headache.
On the part of the musculoskeletal system: myalgia, arthralgia.
Cardio-vascular system: increased blood pressure, Arrhythmia.
Other: allergic reactions.
Contraindications
- Hypercalcemia;
- Hypercalciuria;
- Sarkoidoz;
- Calcium nefrourolitiaz;
- Thyrotoxicosis (Chance of hypersensitivity);
- Renal osteodystrophy with hyperphosphatemia;
- hypervitaminosis D;
- Hypersensitivity to vitamin D3.
FROM caution should be prescribed for atherosclerosis, Heart Failure, renal failure, pulmonary tuberculosis (active form), giperfosfatemii, phosphate nefrourolitiaze, organic heart disease, acute and chronic liver and kidney diseases, diseases of the digestive tract ( incl. gastric ulcer and duodenal ulcer), Pregnancy and lactation, hypothyroidism.
Pregnancy and lactation
Chronic overdose (hypercalcemia, penetration of metabolites of vitamin D3 placenta), arising during pregnancy in the case of long-term use of the drug in high doses, defects can cause physical and mental development of the fetus.
Vitamin D3 and its metabolites are excreted in breast milk.
During pregnancy and lactation the daily dose should not exceed kolekaltsiferola 600 ME.
Cautions
At doses in excess of 1000 IU / day, and when taking the drug continuously for several months recommended periodic determination of calcium and phosphorus concentrations in blood serum to avoid chronic hypervitaminosis D3 and hyperphosphatemia.
Overdose
Symptoms of hypervitaminosis D: early (due to hypercalcemia) – constipation or diarrhea, dryness of the oral mucosa, headache, thirst, thamuria, nocturia, polyuria, anorexia, metallic taste in mouth, nausea, vomiting, unusual tiredness, generalized weakness, hypercalcemia, hypercalciuria; later – bone pain, clouding of urine (appearance in the urine hyaline cylinders, proteinuria, leukocyturia), increased blood pressure, itching, photosensitivity of the eye, conjunctival hyperemia, arrhythmia, drowsiness, myalgia, nausea, vomiting, pancreatitis, gastralgia, weight loss; rarely – psychosis (mental changes and mood).
Symptoms of chronic overdose of vitamin D (when administered within a few weeks or months for adults in doses 20-60 th. IU / day, for children – 2-4 th. IU / day): calcification of soft tissues, kidney, light, blood vessels, arterial hypertension, renal and chronic heart failure (These effects are most often associated with the accession of hypercalcaemia hyperphosphataemia), dysplasia in children (long term administration of a dose 1.8 IU / day).
Treatment: removal of the drug, a diet low in calcium, consumption of large quantities of liquid, GCS assignment, a-токоферола, ascorbic acid, retinol, tiamina, in severe cases – in / introduction 0.9% sodium chloride solution, furosemida, electrolytes, hemodialysis. There is no specific antidote. To eliminate overdosing in some cases it is recommended to determine the concentration of calcium in blood.
Drug Interactions
At the same time taking the drug Vigantol with thiazide diuretics increases the risk of hypercalcemia.
In an application with phenytoin (increase in the rate of biotransformation), kolestiraminom, GCS, calcitonin, etidronovoy Pamidronic derivatives and acids, plicamycin, Gallium nitrate reduces the effectiveness of the drug Vigantol.
Retinol while the use of Vigantolom reduces the toxicity of the latter.
Barbiturates, while the use Vigantolom increase the rate of biotransformation kolekaltsiferola.
Vigantol while the application increases the toxicity of cardiac glycosides.
Prolonged therapy with Vigantol against the backdrop of the simultaneous application of antacid, containing aluminum and magnesium, increases their concentration in blood and the risk of intoxication (especially in the presence of chronic renal failure).
Cholestyramine, colestipol, mineral oil reduces the absorption from the gastrointestinal tract kolekaltsiferola, which requires increasing the dose while the use of the above drugs.
Kolekaltsiferol increases the absorption of phosphorus-containing drugs and the risk of hyperphosphataemia.
In an application with a sodium fluoride Vigantola interval between doses should be at least 2 no, tetracyclines with oral forms – no less 3 no.
Concomitant use of other vitamin D analogues3 It increases the risk of hypervitaminosis.
Conditions of supply of pharmacies
The drug is released under the prescription.
Conditions and terms
The drug should be stored out of reach of children, dark place at a temperature of 15 ° to 25 ° C. Shelf life – 5 years.
