Pharmacodynamics. vitamin d3 is an active antirachitic factor. The most important function of vitamin D is to regulate calcium and phosphate metabolism, which contributes to proper mineralization and skeletal growth.
Vitamin D3 is a natural form of vitamin D that is produced in humans by exposure to sunlight. Compared to vitamin D2, it is characterized by 25% higher activity.
It is essential for the functioning of the parathyroid glands, intestines, kidneys and skeletal system. Colecalciferol plays an essential role in the absorption of calcium and phosphates from the intestines, in the transport of mineral salts and in the process of bone calcification, and regulates the excretion of calcium and phosphates by the kidneys. The presence of calcium ions in the blood in physiological concentrations ensures the maintenance of skeletal muscle tone, myocardial function, promotes the conduction of nervous excitement, and regulates the blood coagulation process. Vitamin D is also involved in the functioning of the immune system by influencing the production of lymphokines.
Lack of vitamin D3 in food, weakening of its absorption, calcium deficiency, as well as insufficient exposure to the sun during the period of rapid growth of the child lead to rickets, and in adults - to osteomalacia, in pregnant women - to the appearance of symptoms of tetany and non-formation of tooth enamel in newborns.
Women in the period of menopause, who often suffer from osteoporosis, due to hormonal imbalance, need to increase the dose of vitamin D3.
Suction. A water solution of vitamin D3 is better absorbed than an oil solution. Premature babies have insufficient formation and flow of bile into the intestines, which disrupts the absorption of vitamins in the form of oil solutions.
After oral administration, colecalciferol is absorbed in the small intestine.
Distribution. Penetrates through the placental barrier and into breast milk.
Metabolism. It is metabolized in the liver and kidneys, turning into an active metabolite - calcitriol, which combines with a carrier protein and is transported to target organs (intestines, bones, kidneys). The half-life in the blood is several days and may increase in the case of kidney disease.
Excretion. It is excreted in urine and feces.
Vitamin D3 is involved in the regulation of phosphorus and calcium metabolism in the body 6 hours after taking the preparation.
After taking vitamin D3, after 48 hours, there is a significant increase in the level of cholecalciferol in the blood plasma.
Prevention of rickets, including in premature newborns; prevention of vitamin d3 deficiency in patients with malabsorption and high-risk patients without malabsorption; maintenance treatment for osteoporosis; treatment of rickets and osteomalacia. treatment of hypoparathyroidism.
The preparation is intended for oral administration. 1 drop contains 500 IU of vitamin d3. to accurately measure the dose, hold the bottle at a 45 ° angle while dispensing. for adults and older children, take the preparation in a spoonful of liquid. for infants, drops are given in a spoonful of water, milk or porridge. add the preparation to food immediately before using it.
Adults
Prevention of rickets. The recommended dose of the preparation is 1 drop (about 500 IU of vitamin D3) per day.
Prevention of vitamin D3 deficiency in patients with malabsorption and high-risk individuals without malabsorption. The recommended dose of the preparation is 1 drop (about 500 IU of vitamin D3) per day.
Supportive treatment for osteoporosis. The recommended dose of the preparation is 2 drops (about 1000 IU of vitamin D3) per day.
Treatment of rickets and osteomalacia. The recommended dose of the preparation is 2-10 drops per day (1000-5000 IU of vitamin D3 per day). The duration of treatment is within 1 year.
Treatment of hypoparathyroidism. The recommended dose of the preparation depends on the level of calcium in the blood plasma and is 20–40 drops (about 10,000–20,000 IU of vitamin D3) per day. If it is necessary to take higher doses of cholecalciferol, preparations should be used in a higher dosage.
Children. The preparation should be used from the 2nd week of life. During the 2nd year of life, there may be a need for further use of the preparation, especially in winter. Prophylactic and therapeutic doses and the duration of the preparation intake are determined individually by the doctor.
The total recommended dose for the prevention of rickets in premature infants is 2 drops (about 1000 IU of vitamin D3) per day.
The general recommended dose for the treatment of vitamin D3 deficiency in children, including newborns, is 2-10 drops (about 1000-5000 IU of vitamin D3) per day.
The duration of treatment depends on the course and severity of the disease and is determined by the doctor individually. Treatment for rickets and osteomalacia caused by vitamin D3 deficiency lasts for 1 year.
Children. The preparation is used in children from the 2nd week of life.
Hypersensitivity to the active substance or other components of the preparation; hypercalcemia and / or hypercalciuria; hypervitaminosis d; sarcoidosis; renal failure; nephrolithiasis; tuberculosis; pseudohypoparathyroidism (the need for vitamin D may be lower than during the period of normal vitamin sensitivity). rare hereditary fructose intolerance, glucose-galactose malabsorption, sucrose-isomaltase deficiency.
Adverse reactions, as a rule, do not develop when taken in the recommended doses. in the case of individual hypersensitivity to the preparation, which is rarely observed, or as a result of the use of too high doses for a long period, hypervitaminosis may appear d.
From the side of metabolism and nutrition: hypercholesterolemia, weight loss, polydipsia.
From the side of the psyche: depression, decreased libido, mental disorders.
From the nervous system: headache, drowsiness.
From the side of the organ of vision: conjunctivitis, photosensitivity.
From the side of the cardiovascular system: arrhythmia, hypertension.
From the digestive tract: loss of appetite, nausea, vomiting, constipation, dry mouth, flatulence, abdominal pain, diarrhea, dyspepsia, pancreatitis.
From the liver and biliary tract: increased activity of aminotransferases.
From the immune system, skin and subcutaneous tissue: hypersensitivity reactions, including urticaria, rash, itching and anaphylactoid reactions (due to the content of benzyl alcohol in the preparation).
Musculoskeletal and connective tissue disorders: myalgia, arthralgia, muscle weakness.
From the kidneys and urinary tract: increased levels of calcium in the blood and / or urine, urolithiasis and tissue calcification, uremia, polyuria.
General disorders: increased sweating.
There have also been reports of rhinorrhea and hyperthermia.
The individual provision of vitamin D requirements should take into account all possible sources of this vitamin.
The determination of the child's daily requirement for vitamin D and the method of its use should be set individually and verified during periodic studies, especially in the first months of life.
Combination therapy with vitamin D or calcium should be carried out only under medical supervision and with monitoring of the level of calcium in blood plasma and urine. It is not recommended to use colecalciferol at the same time as high doses of calcium. Too high doses of the preparation, used for a long time, or loading doses can cause chronic hypervitaminosis D3.
During the use of the preparation, it is recommended to control the level of calcium, phosphate and glucose in the blood plasma and in the urine, and in the case of long-term treatment - to control the level of creatinine in the blood plasma.
The preparation should be used with caution in immobilized patients, persons with impaired renal function, cardiovascular diseases and patients taking simultaneously thiazides and cardiac glycosides.
The preparation should be used with caution in infants born with a small anterior crown.
Application during pregnancy or lactation. During pregnancy, the preparation should not be used in high doses due to the possibility of a teratogenic effect in case of an overdose.
Vitamin D passes into breast milk, therefore, during breastfeeding, the preparation should be used only as directed by a doctor.
The ability to influence the reaction rate when driving vehicles or other mechanisms. There are no messages for today. However, when driving vehicles or other mechanisms, it is recommended to be especially careful, given the possibility of adverse reactions from the nervous system.
With the simultaneous use of colecalciferol with other preparations, the following interactions are possible:
Possible antagonism between cholecalciferol and preparations that are prescribed for hypercalcemia, such as calcitonin, etidronate, pamidronate.
Symptoms in case of an overdose of colecalciferol, hypercalcemia develops (occurs after the use of 50,000-100,000 IU of vitamin d3), hypercalciuria, renal calcifications and bone damage, as well as changes in the cardiovascular system.
Overdose is accompanied by the following effects: muscle weakness, loss of appetite, nausea, vomiting, constipation, polydipsia, polyuria, drowsiness, photosensitivity, pancreatitis, rhinorrhea, hyperthermia, decreased libido, conjunctivitis, hypercholesterolemia, increased activity of transaminases, hypertension. Muscle and joint pain, headache, and weight loss are common symptoms. Renal dysfunction develops with albuminuria, erythrocyturia and polyuria, increased loss of potassium, hypostenuria, nocturia and an increase in blood pressure of an average degree. In severe cases, clouding of the cornea is possible, less often - edema of the papilla of the optic nerve, inflammation of the iris up to the development of cataracts.
Kidney stones and calcification of soft tissues such as blood vessels, heart, lungs and skin can form. Cholestatic jaundice rarely develops.
Treatment. In case of overdose, the preparation should be discontinued. Depending on the degree of hypercalcemia, a diet with a low calcium content or without calcium, drinking a lot of fluids, forced diuresis induced by the administration of furosemide, as well as taking corticosteroids and calcitonin are recommended.
In the case of normal functioning of the kidneys, the level of calcium significantly decreases with the introduction of an infusion solution of sodium chloride (3-6 liters for 24 hours) with the addition of furosemide, in some cases, 15 mg / kg of body weight / hour of sodium edetate should also be used, constantly monitoring calcium level and ECG. In oligoanuria, on the contrary, hemodialysis is necessary. There is no specific antidote.
At a temperature not exceeding 25 ° C in the original packaging. after opening the bottle, the preparation can be used within 6 months.
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