Instructions for Vigantol (Colecalciferol) oil solution 10 ml
Release Form:
Oil inlet solution
Description:
The solution for reception inside oil transparent, slightly yellowish, viscous.
1 ml
calciferol 500 ug (20,000 ME)
Auxiliary substances: Triglycerides are mediocre chain - 939.5 mg.
10 ml - dark glass bottles with cap cap (1) - cardboard packs.
ATX codes
A11CC05 Colecalciferol
Pharmacological groups / Group membership:
A drug that regulates the exchange of calcium and phosphorus
Active substance
colecalciferol
Pharmacy Group
Vitamin-Calcium-phosphorous exchange regulator
Retention Terms:
The drug Vigantol should be stored in a place not accessible to children, protected from light at temperatures from 15° to 25° C.
Shelf life
Shelf life - 5 years.
Pharmaceuticals:
A drug that regulates the exchange of calcium and phosphorus. Fills vitamin D3 deficiency. Increases the intake of calcium in the intestine and the reabsorption of phosphates in the kidneys. Helps mineralize bones and is necessary for normal functioning of the parachythide glands.
Testimonials:
- Rachit prevention and treatment;
- Prophylaxis of vitamin D deficiency in high-risk patients (malabsorption, chronic intestinal diseases, biliar liver cirrhosis, stomach resection and/or small intestine condition);
- osteoporosis therapy (various genesis);
- osteomalation (against the backdrop of mineral exchange disorders in patients over 45 years of age, long-term immobilization in case of injuries, adherence to diet with refusal to take milk and dairy products);
- treatment of hiposaratirosis and pseudo-pseudo-pratireosis.
- Method of application, course and dosage
- The drug is taken in with milk or other liquid.
Rachite prevention: Vigantol is given 1 drop (about 667 ME of vitamin D3) each day from 2 weeks of life. Premature children are given 2 drops (1334 ME vitamin D3) each day from 2 weeks of life. The drug should be taken during the first and second years of life, especially during the winter months.
Rachite treatment: prescribe 2-8 drops (about 1334-5336 ME vitamin D3)/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 ME vitamin D3)/day.
Prevention of vitamin D3 deficiency in malabsorption syndrome: 5-8 drops (about 3335-5336 ME vitamin D3)/day.
Treatment of osteomalation caused by vitamin D3 deficiency: 2-8 drops (about 1334-5336 ME vitamin D3)/day. Treatment should be continued for 1 year.
Osteoporosis Support Therapy: 2-5 drops (about 1334-3335 ME vitamin D3)/day.
Treatment of hipomateryrosis and pseudo-pseudo-pratireosis: Depending on the plasma concentration of calcium, 15-30 drops Vigantol (about 10,005-20,010 ME of vitamin D3) are prescribed per day. Concentration of calcium in the blood should be checked within 4-6 weeks, then every 3-6 months, and the dose adjusted to the content of calcium in the blood.
Overdose:
Symptoms of hypervitamin D3: Early (caused by hypercalciemia) - constipation or diarrhea, dry mucous membranes of the mouth, headache, thirst, pollakiuria, nicaturia, polyuria, anorexia, metal Taste in the mouth, nausea, vomiting, unusual fatigue, general weakness, amdynamia, dehydration, hypercalciemia, hypercalciuria, 25-dihydrosis increase in blood plasma colecalciferol; later - bone pain, urine cloudiness (appearance of hyaline cylinder in urine, proteinuria, leukocyture), AD enhancement, skin itching, eye photosensitivity, conjunctive hyperemia arrhythmia, sleepiness, myalgia, vomiting, pancreatitis, gastargy, body weight loss; Rarely - changes in psyche (up to the development of psychosis) and mood.
Symptoms of chronic overdosing of vitamin D3 (in case of taking for several weeks or months for adults in doses of 20-60 thousand. Me/day, for children - 2-4 thousand. ME/day): Calcinosis of soft tissues, kidneys, lungs, blood vessels, elevation of AD, kidney and heart failure (these effects most often occur when joining hypercalciemia hyperphosphatemia), disruption of children's growth (long-term intake) dose 1.8 ME/day).
Treatment: In case of acute or chronic overdose, treatment of developing hypercalciemia is necessary. Depending on the severity of hypercalciemia, the following measures are applied: elimination of drug, low-calcium diet, consumption of large quantities of liquid, prescription of GKS, vitamin E, ascorbic acid, retinol, tiamine, pantotenic acid, riboflavin; In severe cases, 0.9% sodium chloride solution, furosemide, electrolytes, hemodialysis, calcitonin introduction. No specific antidote exists. To avoid overdose, it is recommended to determine the blood calcium concentration in some cases.
Drug Interaction Vigantol:
Phenitoin, primidon and barbiturate group preparations increase the need for vitamin D3 due to the increase in the rate of biotransformation.
Long-term therapy, coupled with the simultaneous use of anticides containing aluminum and magnesium ions, increases their blood concentration and the risk of intoxication (especially in the case of chronic renal failure).
Calcitonin, bisphosphonates (including ethydron, pamidronic acid), plicamycin reduce the effect.
Colestiramine, colostipol reduce the absorption from LCD of fat-soluble vitamins and require a higher dose.
Increases the absorption of phosphorous drugs and the risk of hyperphosphatemia.
When applied simultaneously with sodium fluoride, the interval between the reception shall be at least 2 hours; with oral forms of tetracyclines - not less than 3 hours.
In the accompanying therapy GCS may decrease the effectiveness of the drug.
Co-therapy with cardiac glycosides can increase their toxic potential due to the development of hypercalciemia. In such patients, it is necessary to control the levels of calcium, ECG, and correct doses of heart glycosis.
The concomitant therapy of derivatives of benzodiazepine increases the risk of hypercalciemia.
Vitamin D3 can be combined with metabolites or vitamin D analogs only in exceptional cases and under the control of the calcium level in the blood serum.
Tiazid diuretics can reduce calcium and urine excretion and thus increase the risk of hypercalciemia. In such patients, the blood calcium concentration should be continuously monitored.
Rifampicin and isoniazid may reduce the effect of the drug due to the increase in the rate of biotransformation.
Vigantol does not interact with food.
Use in pregnancy and breastfeeding
Vigantol should be used with care during pregnancy and lactation (breastfeeding).
Adequate vitamin D3 is required for pregnancy and breastfeeding.
In overdose, hypercalciemia and transplacental intrusion of vitamin D3 metabolites into the fetus may occur, which may lead to teratogenic action: Delays in the mental and physical development of the fetus, special forms of aortal stenosis.
Vitamin D3 and its metabolites are extracted with breast milk.
Side Action:
From the digestive system: constipation, meteorism, nausea, abdominal pain, diarrhea, diarrhea.
From metabolism: hypercalciemia and hypercalciuria in case of taking the drug for a long time in high doses, polyuria.
On the side of the bone and muscle system: myalgia, arthallgia.
On the side of the cardiovascular system: boosting AD, arrhythmia.
Allergic reactions: itching, rash, pebble.
Others: Headache, kidney failure, acute tuberculosis in the lungs.
Contraindications to use:
hypercalciemia;
hypercalciuria;
calcium nephrolithiasis;
tireotoxicosis (probability of hypersensitivity);
renal osteodystrophy with hyperphosphatemia;
hypervitamin D;
increased sensitivity to drug components.
Care should be taken to prescribe drugs for atherosclerosis, heart failure, kidney failure, sarcoidosis or other granulematosis, hyperphosphatemia, phosphate nephrourolitis Azeas (including anamnesis), organic heart lesions, acute and chronic liver and kidney diseases, LCD diseases (including stomach ulcer and duodenal intestinal disease), bending tyreosis, during pregnancy and breastfeeding, when taking additional amounts of vitamin D3 (e.g. in other preparations).
Special Instructions Vigantol:
For pseudo-pomateriosis, it is necessary to control the presence of signs of intoxication. Since there may be phases of normal sensitivity to vitamin D in pseudo-pomapateriosis, it is necessary to correct the dose of the drug. In the case of pseudo-pomatyroiosis, which has arisen after the operative treatment of thyroid glands, it is necessary to stop the use of the drug as the recovery of the perpomatic glands to prevent intoxication with vitamin D.
Impact on the ability to drive vehicles and mechanisms
No studies were conducted on the impact on vehicle driving and mechanisms.
Application for kidney disorders
With care to prescribe for acute and chronic liver diseases.
Application for liver disorders
With care to prescribe for acute and chronic kidney diseases.
Terms of implementation
The drug Vigantol is released according to the prescription.
Application of children
The application is possible according to the dosage regime.
Nozology (ICD codes)
Hyposaratirosis
Pseudogiposatyroiosis
Vitamin D deficiency
Rakhit Active
Alimentary calcium deficiency
Post-menopausal osteoporosis with pathological fracture
Osteoporosis with a pathological fracture after ovarian removal
Drug osteoporosis with pathological fracture
Idiopathic osteoporosis with pathological fracture
Another osteoporosis with a pathological fracture
Post-menopause osteoporosis
Osteoporosis after ovarian removal
Osteoporosis caused by immobility
Drug osteoporosis
Idiopathic osteoporosis
Other osteoporosis (old osteoporosis)
Osteoporosis in diseases classified in other fields
Osteomaly in adults