Aquadetrim, 500 me 90 pcs.

Aqueous vitamin D3 solution is absorbed better than the oil solution. Premature infants have insufficient formation and inflow of bile into the intestine, which impairs absorption of vitamins in the form of oil solutions.

After oral administration, colecalciferol is absorbed in the small intestine. It is metabolized in the liver and kidneys. Half-life period of colocalciferol from blood is several days and may be prolonged in case of renal insufficiency. The drug passes through the placental barrier and into the mother’s milk.

It is excreted by the kidneys in small amounts, most of it is excreted with the bile. Vitamin D3 has a property of cumulation.

Indications

– Prevention and treatment of vitamin D deficiency.

– Prevention and treatment of rickets.

– In the complex treatment of osteoporosis, including postmenopausal.

Pharmacological effect

An aqueous solution of vitamin D3 is absorbed better than an oil solution. In premature babies, there is insufficient formation and flow of bile into the intestines, which interferes with the absorption of vitamins in the form of oil solutions.

After oral administration, colecalciferol is absorbed in the small intestine. Metabolized in the liver and kidneys. The half-life of colecalciferol from the blood is several days and may be prolonged in cases of renal failure. The drug penetrates the placental barrier and into mother’s milk.

It is excreted by the kidneys in small quantities, most of it is excreted in bile. Vitamin D3 has the property of cumulation.

Special instructions

Avoid overdose. Individual provision of a specific need must take into account all possible sources of this vitamin. Too high doses of vitamin D3, used over a long period of time or shock doses, can cause chronic hypervitaminosis D3.

The determination of a child’s daily need for vitamin D and the method of its use should be determined by a doctor individually and each time subject to correction during periodic examinations, especially in the first months of life.

When an adequate level of vitamin D concentration in the blood is achieved (> 30 ng/ml 25(OH)D) in adults, maintenance therapy with Aquadetrim can be continued at a dose of 1500-2000 IU (3-4 tablets) per day.

If water is not available, the tablet can be dissolved in the mouth.

Do not use high doses of calcium at the same time as vitamin D3.

During treatment, periodic monitoring of phosphate concentrations in the blood and urine is necessary.

With long-term use of colecalciferol, it is necessary to regularly determine the level of calcium in the blood serum and urine, and also evaluate renal function by measuring serum creatinine levels. If necessary, the dose of colecalciferol should be adjusted depending on the level of calcium in the blood serum.

Active ingredient

Colecalciferol

Composition

Tablets – 1 tablet:

Active ingredient:

vitamin D3 100SD/S dry -5 mg (corresponds to 500 IU colecalciferol).

Excipients:

d,l-alpha-tocopherol,

modified starch,

sucrose,

sodium ascorbate crystalline,

medium chain triglycerides

silicon dioxide,

mannitol,

sodium benzoate

Contraindications

Hypersensitivity to the components of the drug.

Hypervitaminosis D, increased concentration of calcium in the blood (hypercalcemia), increased excretion of calcium in the urine (hypercalciuria), urolithiasis (formation of calcium oxalate stones), sarcoidosis, acute and chronic diseases of the liver and kidneys, renal failure, active form of pulmonary tuberculosis, pseudohypoparathyroidism, sucrose / isomaltase deficiency, fructose intolerance, glucose-galactose malabsorption.

With caution: state of immobilization, atherosclerosis, during pregnancy and breastfeeding.

In patients taking thiazide diuretics, as well as in patients with cardiovascular diseases taking cardiac glycosides.

In infants with a predisposition to early overgrowth of fontanelles (when the size of the anterior crown is small from birth).

Side Effects

Hypersensitivity to the components of the drug, hypervitaminosis D (symptoms of hypervitaminosis: loss of appetite, nausea, vomiting; headaches, muscle and joint pain; constipation; dry mouth; polyuria; weakness; mental disorders, including depression; weight loss; sleep disturbance; fever; protein, leukocytes, hyaline casts appear in the urine; increased calcium levels in the blood and its release from urine; possible calcification of the kidneys, blood vessels, lungs).

If signs of hypervitaminosis D appear, it is necessary to discontinue the drug, limit the intake of calcium, and prescribe vitamins A, C and B.

Interaction

Antiepileptic drugs, rifampicin, cholestyramine reduce the reabsorption of vitamin D3.

Use simultaneously with thiazide diuretics increases the risk of hypercalcemia.

Concomitant therapy with cardiac glycosides (digitalis) may increase their toxic potential due to hypercalcemia. In such patients, it is necessary to monitor ECG indicators and calcium levels in the blood plasma and urine, and adjust the dose of cardiac glycosides. And also, it is necessary to monitor the levels of digoxin and digitoxin in the blood plasma if indicated.

Concomitant therapy with glucocorticosteroids may reduce the effectiveness of vitamin D3.

Overdose

Symptoms of overdose: loss of appetite, nausea, vomiting, constipation, anxiety, thirst, polyuria, diarrhea, intestinal colic. Frequent symptoms are headache, muscle and joint pain, mental disorders, including depression, stupor, ataxia and progressive weight loss. Renal dysfunction develops with albuminuria, erythrocyturia and polyuria, increased potassium loss, hyposthenuria, nocturia and increased blood pressure.

In severe cases, clouding of the cornea may occur, less commonly swelling of the optic nerve papilla, inflammation of the iris, and even the development of cataracts. Kidney stones may form and calcification of soft tissues, including blood vessels, heart, lungs and skin, occurs. Cholestatic jaundice rarely develops.

Treatment: Stop using the drug. Contact your doctor. Take plenty of fluids. If necessary, hospitalization may be required.

Functional features

Vitamin D3 is a natural form of vitamin D that is formed in humans in the skin under the influence of sunlight. Compared to vitamin D2, it is characterized by 25% higher activity.

Vitamin D binds to the specific vitamin D receptor (VDR), which regulates the expression of many genes, including the ion channel genes TRPV6 (promotes intestinal calcium absorption), CALB1 (calbindin; promotes calcium transport into the bloodstream), BGLAP (osteocalcin; promotes bone mineralization and calcium homeostasis), SPP1 (osteopontin; regulates osteoclast migration), REN (renin; ensures regulation of blood pressure, being a key element of the renin-angiotensin-aldosterone regulatory system), IGFBP (insulin-like growth factor binding protein; enhances the action of insulin-like growth factor), FGF23 and FGFR23 (fibroblast growth factor 23; regulate the levels of calcium, phosphate anion, processes of fibroblast cell division), TGFB1 (transforming growth factor beta 1; regulates cellular processes division and differentiation of osteocytes, chondrocytes, fibroblasts and keratinocytes), LRP2 (LDL receptor-related protein 2; mediates the endocytosis of low-density lipoproteins), INSR (insulin receptor; provides the effects of insulin on any cell type).

Vitamin D3 is an active antirachitic factor. The most important function of vitamin D3 is to regulate calcium and phosphate metabolism, which promotes proper mineralization and skeletal growth.

Colecalciferol plays a significant role in the absorption of calcium and phosphates in the intestine, in the transport of mineral salts and in the process of bone calcification, and also regulates the excretion of calcium and phosphates by the kidneys.

The concentration of calcium ions in the blood determines the maintenance of muscle tone of skeletal muscles, myocardial function, promotes nervous stimulation, and regulates the process of blood clotting.

Lack of vitamin D in food, impaired absorption, calcium deficiency, as well as insufficient exposure to the sun during the period of rapid growth of a child leads to rickets, in adults – to osteomalacia, pregnant women may experience symptoms of tetany, disruption of the calcification processes of the bones of newborns.

An increased need for vitamin D occurs in women during menopause, as they often develop osteoporosis due to hormonal imbalances. Vitamin D has a number of so-called. extraskeletal effects.

Vitamin D is involved in the functioning of the immune system by modulating cytokine levels and regulating the division of T-helper lymphocytes and the differentiation of B-lymphocytes. A number of studies have noted a decrease in the incidence of respiratory tract infections with vitamin D supplementation.

It has been shown that vitamin D is an important part of the homeostasis of the immune system: it prevents autoimmune diseases (type 1 diabetes, multiple sclerosis, rheumatoid arthritis, inflammatory bowel diseases, etc.).

Vitamin D has antiproliferative and prodifferentiating effects, which determine the oncoprotective effect of vitamin D. It has been noted that the incidence of certain tumors (breast cancer, colon cancer) increases against the background of low levels of vitamin D in the blood.

Vitamin D is involved in the regulation of carbohydrate and fat metabolism by influencing the synthesis of IRS1 (insulin receptor substrate 1; participates in the intracellular pathways of the insulin receptor signal), IGF (insulin-like growth factor; regulates the balance of adipose and muscle tissue), PPAR-5 (activated peroxisome proliferator receptor type 5; promotes the processing of excess cholesterol).

According to epidemiological studies, vitamin D deficiency is associated with the risk of metabolic disorders (metabolic syndrome and type 2 diabetes mellitus). Vitamin D receptors and metabolizing enzymes are expressed in arterial vessels, the heart, and virtually all cells and tissues relevant to the pathogenesis of cardiovascular disease. Antiatherosclerotic effects, renin suppression and prevention of myocardial damage, etc. have been shown in animal models.

Low levels of vitamin D in humans are associated with unfavorable risk factors for cardiovascular pathology, such as diabetes mellitus, dyslipidemia, arterial hypertension, and are associated with the risk of cardiovascular accidents, incl. strokes. Studies in experimental models of Alzheimer’s disease showed that vitamin D3 reduced amyloid accumulation in the brain and improved cognitive function.

Non-interventional human studies have shown that the incidence of dementia and Alzheimer’s disease increases with low vitamin D levels and low dietary intake of vitamin D. Cognitive function and the incidence of Alzheimer’s disease have been impaired with low vitamin D levels.

Manufacturer

Akrikhin JSC, Russia