Vigantolum

Vigantolum – the vitamin drug filling the shortage of D3 vitamin regulating exchange of phosphorus and calcium.

Form of release and structure

Dosage form – Solutio oleosa for intake: viscous, transparent, slightly yellowish (on 10 ml in dark glass bottles with a stopper dropper, in a cardboard pack 1 bottle).

Active ingredient: колекальциферол, in 1 ml – 20 000 ME (500 mkg).

Additional components: triglycerides srednetsepochny.

Indications to use

• Prevention of deficit of vitamin D at patients from groups of high risk (chronic diseases of thin department of intestines, a state after a resection of a stomach and/or a small intestine, biliary cirrhosis, malabsorption);
• Treatment and prevention of rickets;
• Maintenance therapy of osteoporosis of various genesis;
• Treatment of a hypoparathyrosis and pseudohypoparathyroidism;
• Treatment of osteomalacy (owing to observance of diets with refusal of dairy products, a long immobilization because of injuries, at people 45 years are more senior than disturbances of mineral exchange).

Contraindications

Absolute:

• Calcic нефроуролитиаз;
• Hypercalcuria;
• Hypercalcemia;
• Hypervitaminosis of D;
• Renal osteodystrophy with a hyperphosphatemia;
• Thyrotoxicosis;
• Hypersensitivity to drug.

Relative (because of high risk of development of complications it is necessary to observe extra care):

• Atherosclerosis;
• Heart failure;
• Organic lesions of heart;
• Acute and chronic diseases of kidneys and liver;
• Renal failure;
• Digestive tract diseases, including peptic ulcer of a stomach and 12-perstny gut;
• Sarcoidosis or other granulomatoses;
• Hyperphosphatemia;
• Phosphatic нефроуролитиаз, including in the anamnesis;
• Hypothyroidism;
• Pregnancy and lactation;
• Additional reception of D3 vitamin, including as a part of other drugs.

Route of administration and dosage

Vigantolum should be accepted inside with milk or any other liquid.

The recommended doses depending on indications:

• Prevention of rickets: healthy full-term children – on 1 drop daily (since 2 weeks of life); premature children – on 2 drops daily (since 2 weeks of life). It is necessary to accept drug during 1st and 2nd lives, especially in winter months;
• Treatment of rickets: on 2-8 drops a day, reception duration – 1 year;
• Prevention of development of the diseases connected with deficit of D3 vitamin: on 1-2 drops a day;
• Prevention of deficit of D3 vitamin at patients with a sprue: on 5-8 drops a day;
• Maintenance therapy of osteoporosis: on 2-5 drops a day;
• Treatment of the osteomalacy which developed owing to deficit of D3 vitamin: on 2-8 drops a day, therapy duration – 1 year;
• Treatment of a hypoparathyrosis and pseudohypoparathyroidism: till 15-30 drops in days. Concentration of calcium in blood should be checked regularly within the first 4-6 weeks of treatment, further – each 3-6 months. Further the dose can be adjusted according to the content of calcium in blood.

Side effects

• Alimentary system: abdominal pain, nausea, diarrhea or lock, loss of appetite, meteorism;
• Cardiovascular system: arrhythmias, increase in arterial pressure;
• Musculoskeletal system: arthralgia, mialgiya;
• Metabolism: polyuria; at reception in high doses for a long time – a hypercalcuria and a hypercalcemia;
• Allergic reactions: rash, urticaria, itch;
• Others: a renal failure, a headache, an aggravation of tubercular process in lungs.

Special instructions

During treatment of a pseudohypoparathyroidism it is necessary to control a condition of the patient regarding emergence of symptoms of intoxication. Dose adjustment can be required by patients with this disease. At the pseudohypoparathyroidism which developed after operational treatment of a thyroid gland for prevention of intoxication vitamin D it is necessary to stop use of Vigantolum in process of recovery of epithelial bodies.

Researches on an occasion of influence of drug on the speed of reactions and ability to concentration of attention were not conducted.

During pregnancy and a lactation adequate intake of D3 vitamin is required. In case of overdose development of a hypercalcemia and transplacental penetration of metabolites of D3 vitamin into a fruit organism is possible that it is fraught with the teratogenic action which is shown a delay of physical and intellectual fetation, special forms of an aortal stenosis.

Medicinal interaction

• Drugs of group of barbiturates, Primidonum, Phenytoinum: D3 vitamin biotransformation speed because of what the need for it increases increases;
• Bisfosfonata (including pamidronovy and etidronovy acids), calcitonin, пликамицин: efficiency of Vigantolum decreases;
• Magnesium - and aluminum-bearing antacids: their concentration in blood and, as a result, risk of intoxication, especially at patients with a chronic renal failure increases;
• Kolestipol, Colestyraminum: absorption of fat-soluble vitamins decreases (increase in their dose is required);
• Glucocorticosteroids, rifampicin, isoniazid: efficiency of Vigantolum decreases;
• Benzodiazepine derivatives: the risk of development of a hypercalcemia increases;
• Cardiac glycosides: their toxic potential increases (it is necessary to adjust their dose, to control the electrocardiogram and level of calcium);
• Phosphorus drugs: their absorption increases, the risk of development of a hyperphosphatemia increases;
• Thiazide diuretics: removal of calcium with urine decreases, the probability of development of a hypercalcemia increases (it is necessary to monitorirovat the content of calcium in blood).

Vigantolum does not interact with food. In need of it it is possible to combine with analogs or metabolites of vitamin D, but only in exceptional cases and under careful control of level of calcium in blood serum.

In case of the accompanying purpose of peroral tetracyclines between administrations of drugs it is necessary to observe at least 3-hour intervals. At simultaneous use of sodium of fluoride the interval between receptions should not be less than 2 hours.

Terms and storage conditions

To store at a temperature of 15-25 ºС in the place unavailable to children protected from light.

Period of validity – 5 years.