Aquadetrim (Vitamin D3) Soluble tablets 500IU, 60pcs

Composition

Tablets – 1 tab. :

Active ingredient: vitamin D3 100SD / S dry -5 mg (corresponds to 500 IU of colecalciferol). Excipients: d, l-alpha-tocopherol, modified starch, sucrose, sodium ascorbate, medium chain triglycerides, silicon dioxide, mannitol, sodium benzoate.

Pharmacological action

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

After oral use, colecalciferol is absorbed in the small intestine. It is metabolized in the liver and kidneys. The half-life of colecalciferol from the blood is several days and may last in the case of renal failure. The drug penetrates through the placental barrier and into the mother’s milk.

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

Indications

-Prevention and treatment of vitamin D deficiency

– Prevention and treatment of rickets.

– In the complex treatment of osteoporosis, including postmenopausal.

Contraindications

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

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

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

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

Side effects

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

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

Interaction

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

Concomitant use 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 parameters and the level of calcium in blood plasma and urine, adjust the dose of cardiac glycosides. Also, it is necessary to monitor the levels of digoxin and digitoxin in the blood plasma, if indicated.

Concomitant glucocorticoid therapy may reduce the effectiveness of vitamin D3.

How to take, course of use and dosage

Inside.

Dissolve the tablet in water at room temperature (the amount of water is not less than 15 ml – 1 tablespoon). Dissolution of the tablet takes some time (about 1-2 minutes). If the doctor does not prescribe otherwise, the drug is used in the following dosages: :

Preventive doses:

Full-term newborns from 4 weeks of life to 2-3 years of age with proper care and sufficient exposure to fresh air: 500IU (1 tablet) per day.

Preterm children from 4 weeks of age, twins, children in poor living conditions: 1000-1500 IU (2-3 tablets) per day.

In summer, you can limit the dose to 500 IU (1 tablet) per day.

– in healthy adults without malabsorption disorders: 500 IU (1 tablet) per day, in adult patients with malabsorption syndrome: 3000-5000 IU (6-10 tablets) per day (except for patients with glucose-galactose malabsorption).

– pregnant women: a daily dose of 500 IU (1 tablet) of vitamin D3 for the entire period of pregnancy, or taking 1000 IU (2 tablets) per day, starting from the 28th week of pregnancy.

In the postmenopausal period,500-1000IU (1-2 tablets) per day.

Therapeutic doses:

For rickets: daily 1000-5000 IU (2-10 tablets), depending on the severity of rickets (I, II, or III) and the course of the course, for 4-6 weeks, under careful monitoring of the clinical condition and the study of biochemical parameters (calcium, phosphorus, alkaline phosphatase) of blood and urine. You should start with 1000IU within 3-5 days. Then, with good tolerance, the dose is increased to an individual therapeutic dose (most often 3000 IU). A dose of 5000 IU is prescribed only for severe bone changes.

If necessary, after a one-week break, you can repeat the course of treatment. Treatment is carried out until a clear therapeutic effect is obtained, followed by switching to a preventive dose of 500-1500 IU per day.

In the complex treatment of postmenopausal osteoporosis: 500-1000IU (1-2 tablets) per day. To maintain an adequate level of vitamin D concentration in the blood (> 30 ng / ml 25(OH)D) – 2000IU (4 tablets) per day. Dosage, as a rule, is prescribed taking into account the amount of vitamin D that comes from food.

Overdose

Symptoms of overdose: decreased appetite, nausea, vomiting, constipation, restlessness, thirst, polyuria, diarrhea, intestinal colic. Common symptoms include headache, muscle and joint pain, and mental disorders, including depression, stupor, ataxia, and progressive weight loss. Impaired renal function develops with albuminuria, erythrocyturia and polyuria, increased potassium loss, hypostenuria, nocturia and increased blood pressure.

In severe cases, corneal opacity may occur, less often edema of the papilla of the optic nerve, inflammation of the iris up to the development of cataracts. Kidney stones can form, and soft tissue calcification occurs, including blood vessels, heart, lungs, and skin. Rarely develops cholestatic jaundice.

Treatment

Stop using the drug. Consult a doctor. Take large amounts of fluids. If necessary, hospitalization may be required.

Functional features

Vitamin D3 is a naturally occurring form of vitamin D that is formed in humans in the skin when exposed to 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 TRPV6 ion channel genes (provides calcium absorption in the intestine), CALB1 (calbindin; provides calcium transport to the bloodstream), BGLAP (osteocalcin; provides bone mineralization and calcium homeostasis), SPP1 (osteopontin; regulates osteoclast migration), REN (renin; regulates blood pressure, being a component of the immune system). key element of the renin-angiotensin-aldosterone regulatory system), IGFBP (binding protein of insulin – like growth factor; enhances the action of insulin-like growth factor), FGF23 and FGFR23 (fibroblast growth factor 23; regulate the levels of calcium, phosphate anion, fibroblast cell division processes), TGFB1 (transforming growth factor beta-1; regulates the processes of cell division and differentiation of osteocytes, chondrocytes, fibroblasts and keratinocytes), LRP2 (LDL receptor-bound protein 2; mediates endocytosis of low-density lipoproteins), INSR (insulin receptor; provides the effects of insulin on any cell types).

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 regulates the excretion of calcium and phosphates by the kidneys.

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

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

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

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

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

Vitamin D has antiproliferative and prodifferentiating effects, which determine the oncoprotective effect of vitamin D. It is noted that the frequency of some 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 (a substrate of the insulin receptor 1; participates in the intracellular pathways of insulin receptor signaling), IGF (insulin-like growth factor; regulates the balance of fat 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 related to the pathogenesis of cardiovascular diseases. Anti-atherosclerotic action, renin suppression and prevention of myocardial damage are shown in animal models.

Low levels of vitamin D in humans are associated with unfavorable risk factors for cardiovascular diseases, such as diabetes mellitus, dyslipidemia, arterial hypertension, and are associated with the risk of cardiovascular disasters, including strokes. Studies in experimental models of Alzheimer’s disease have shown that vitamin D3 reduced amyloid accumulation in the brain and improved cognitive function. Non-conservative 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 were reported to be impaired when vitamin D levels were low.

Special instructions

Avoid overdosing.

Individual provision for a specific need should take into account all possible sources of this vitamin. Too high doses of vitamin D3, applied for a long time or shock doses, can cause chronic D3 hypervitaminosis.

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

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

In the absence of water, the tablet can be dissolved in the mouth.

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

During treatment, it is necessary to periodically monitor the concentration of phosphates in the blood and urine.

When taking colecalciferol for a long time, it is necessary to regularly determine the level of calcium in the blood serum and urine, as well as evaluate kidney 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