Akvadetrim oral drops 15000 IU / ml, 10ml

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BIDL3178240
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Expiration Date: 05/2027

Russian Pharmacy name:

Аквадетрим капли для приема внутрь 15000МЕ/мл, 10мл

Akvadetrim oral drops 15000 IU / ml, 10ml

Prevention and treatment:

  • vitamin D deficiency;

  • rickets and rickets-like diseases;

  • hypocalcemic tetany;

  • osteomalacia;

  • metabolic-based bone diseases (such as hypoparathyroidism and pseudohypoparathyroidism).

Osteoporosis treatment, incl. postmenopausal (as part of complex therapy).

The drug is taken orally, in 1 spoonful of liquid (1 drop contains 500 IU of colecalciferol). Unless otherwise prescribed by the doctor, the drug is used in the following dosages:

In order to prevent full-term newborns from 4 weeks of life to 2-3 years , with proper care and sufficient exposure to the fresh air, the drug is prescribed in a dose of 500 IU (1 drop) / day.

Premature babies from 4 weeks of age, twins and children living in unfavorable conditions are prescribed 1000-1500 IU (2-3 drops) / day.

In the summer, the dose can be reduced to 500 IU (1 drop) / day.

Adult healthy individuals without malabsorption - 500 IU (1 drop) / day; adult patients with malabsorption syndrome - 3000-5000 IU (6-10 drops) / day.

Pregnant women are prescribed 500 IU (1 drop) / day daily throughout pregnancy, or 1000 IU (2 drops) / day, starting at 28 weeks of gestation.

In the postmenopausal period, 500-1000 IU (1-2 drops) / day are prescribed.

For the purpose of treating rickets, the drug is prescribed daily at a dose of 1000-5000 IU (2-10 drops) / day for 4-6 weeks, depending on the severity of rickets (I, II or III) and the course of the disease. In this case, the patient's clinical condition and biochemical parameters (the level of calcium, phosphorus, alkaline phosphatase activity in the blood and urine) should be monitored. The initial dose is 1000 IU / day for 3-5 days, then, with good tolerance, the dose is increased to an individual therapeutic dose (usually up to 3000 IU / day). A dose of 5000 IU / day is prescribed only for pronounced bone changes.

If necessary, after a 1 week break, the course of treatment can be repeated.

Treatment should be continued until a clear therapeutic effect is obtained, followed by a transition to a prophylactic dose of 500-1500 IU / day.

In the treatment of rickets-like diseases, 20,000-30,000 IU (40-60 drops) / day are prescribed, depending on age, body weight and severity of diseases, under the control of blood biochemical parameters and urinalysis. The course of treatment is 4-6 weeks. Treatment is carried out under the supervision of a physician.

In the treatment of postmenopausal osteoporosis (as part of complex therapy), 500-1000 IU (1-2 drops) / day are prescribed.

The dose is set individually, taking into account the amount of vitamin D supplied with food.

1 ml (30 drops)

Colecalciferol (vit. D3) - 15,000 IU

Excipients : macrogol glyceryl ricinoleate, sucrose, sodium hydrogen phosphate dodecahydrate, citric acid monohydrate, anise flavor, benzyl alcohol, purified water.

  • hypervitaminosis D;

  • hypercalcemia;

  • hypercalciuria;

  • urolithiasis (the formation of calcium oxalate stones in the kidneys);

  • sarcoidosis;

  • acute and chronic diseases of the liver and kidneys;

  • renal failure;

  • active form of pulmonary tuberculosis;

  • hypersensitivity to the components of the drug (especially to benzyl alcohol).

The drug should be used with caution in patients in a state of immobilization; when taking thiazides, cardiac glycosides (especially digitalis glycosides); during pregnancy and lactation (breastfeeding); in infants with a predisposition to early overgrowth of fontanelles (when the small size of the anterior fontanelle is established from birth).

Clinical and pharmacological group: A drug that regulates the exchange of calcium and phosphorus

Pharmaco-therapeutic group: Calcium-phosphorus metabolism regulator

pharmachologic effect

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

Vitamin D3 is a naturally occurring form of vitamin D that is produced in human skin by exposure to sunlight. Compared to vitamin D2, it is characterized by 25% higher activity.

Vitamin D binds to a 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 into the bloodstream), BGLAP (osteocalcin; provides bone mineralization tissue and calcium homeostasis), SPP1 (osteopontin; regulates osteoclast migration), REN (renin; regulates blood pressure, being a key element of the RAAS), IGFBP (binding protein insulin-like growth factor; enhances the action of insulin-like growth factor), FGF23 and FGFR23 (growth factor fibroblasts 23; regulate the levels of calcium, phosphate anion, processes of cell division of fibroblasts), TGFB1 (transforming growth factor beta-1; regulates the processes of cell division and differentiation of osteocytes, chondrocytes,fibroblasts and keratinocytes), LRP2 (LDL-receptor-associated protein 2; mediates low-density lipoprotein endocytosis), INSR (insulin receptor; provides insulin effects on all cell types).

Colecalciferol plays an essential role in the absorption of calcium and phosphate in the intestine, in the transport of mineral salts and in the process of bone calcification, and also regulates the excretion of calcium and phosphate by the kidneys.

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

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 the child leads to rickets, in adults - to osteomalacia, pregnant women may experience symptoms of tetany, impaired calcification of the bones of newborns.

An 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 off-skeletal effects.

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

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

Vitamin D has antiproliferative and differentiating effects, which determine the oncoprotective effect of vitamin D. It has been noted that the incidence of some tumors (breast cancer, colon cancer) increases with a low level of vitamin D in the blood.

Vitamin D is involved in the regulation of carbohydrate and fat metabolism by influencing the synthesis of IRS1 (substrate of the insulin receptor 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-? (activated receptor of peroxisome proliferators, type?; 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, heart and practically all cells and tissues related to the pathogenesis of cardiovascular diseases. In animal models, anti-atherosclerotic action, renin suppression and prevention of myocardial damage have been shown, and more. Low levels of vitamin D in humans are associated with unfavorable risk factors for cardiovascular disease, 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 have shown that vitamin D3 reduced the accumulation of amyloid in the brain and improved cognitive function. Non-interventional studies in humans have shown that the incidence of dementia and Alzheimer's disease increases with low vitamin D levels and low dietary vitamin D intake. Cognitive function and Alzheimer's disease have been impaired with low vitamin D levels.

Pharmacokinetics

Suction

An aqueous solution of colecalciferol is absorbed better than an oil solution (this is important when used in premature babies, because in this category of patients there is a lack of production and flow of bile into the intestine, which disrupts the absorption of vitamins in the form of oil solutions).

After oral administration, colecalciferol is absorbed from the small intestine.

Distribution and metabolism

It is metabolized in the liver and kidneys.

Penetrates the placental barrier. Excreted in breast milk. Colecalciferol accumulates in the body.

Withdrawal

T1 / 2 of cholecalciferol from the blood is several days. It is excreted by the kidneys in a small amount, most of it is excreted in the bile.

Pharmacokinetics in special clinical situations

With renal failure, an increase in T1 / 2 is possible.

Indications

Prevention and treatment:

  • vitamin D deficiency;

  • rickets and rickets-like diseases;

  • hypocalcemic tetany;

  • osteomalacia;

  • metabolic-based bone diseases (such as hypoparathyroidism and pseudohypoparathyroidism).

Osteoporosis treatment, incl. postmenopausal (as part of complex therapy).

Dosage regimen

The drug is taken orally, in 1 spoonful of liquid (1 drop contains 500 IU of colecalciferol). Unless otherwise prescribed by the doctor, the drug is used in the following dosages:

In order to prevent full-term newborns from 4 weeks of life to 2-3 years , with proper care and sufficient exposure to the fresh air, the drug is prescribed in a dose of 500 IU (1 drop) / day.

Premature babies from 4 weeks of age, twins and children living in unfavorable conditions are prescribed 1000-1500 IU (2-3 drops) / day.

In the summer, the dose can be reduced to 500 IU (1 drop) / day.

Adult healthy individuals without malabsorption - 500 IU (1 drop) / day; adult patients with malabsorption syndrome - 3000-5000 IU (6-10 drops) / day.

Pregnant women are prescribed 500 IU (1 drop) / day daily throughout pregnancy, or 1000 IU (2 drops) / day, starting at 28 weeks of gestation.

In the postmenopausal period, 500-1000 IU (1-2 drops) / day are prescribed.

For the purpose of treating rickets, the drug is prescribed daily at a dose of 1000-5000 IU (2-10 drops) / day for 4-6 weeks, depending on the severity of rickets (I, II or III) and the course of the disease. In this case, the patient's clinical condition and biochemical parameters (the level of calcium, phosphorus, alkaline phosphatase activity in the blood and urine) should be monitored. The initial dose is 1000 IU / day for 3-5 days, then, with good tolerance, the dose is increased to an individual therapeutic dose (usually up to 3000 IU / day). A dose of 5000 IU / day is prescribed only for pronounced bone changes.

If necessary, after a 1 week break, the course of treatment can be repeated.

Treatment should be continued until a clear therapeutic effect is obtained, followed by a transition to a prophylactic dose of 500-1500 IU / day.

In the treatment of rickets-like diseases, 20,000-30,000 IU (40-60 drops) / day are prescribed, depending on age, body weight and severity of diseases, under the control of blood biochemical parameters and urinalysis. The course of treatment is 4-6 weeks. Treatment is carried out under the supervision of a physician.

In the treatment of postmenopausal osteoporosis (as part of complex therapy), 500-1000 IU (1-2 drops) / day are prescribed.

The dose is set individually, taking into account the amount of vitamin D supplied with food.

Side effect

Symptoms of hypervitaminosis D: loss of appetite, nausea, vomiting; headache, muscle and joint pain; constipation; dry mouth; polyuria; weakness; mental disorder, incl. depression; loss of body weight; sleep disturbance; temperature increase; protein, leukocytes, hyaline casts appear in the urine; an increase in the level of calcium in the blood and its excretion in the urine; possible calcification of the kidneys, blood vessels, lungs. When signs of hypervitaminosis D appear, it is necessary to cancel the drug, limit the intake of calcium, prescribe vitamins A, C and B.

Others: hypersensitivity reactions are possible.

Contraindications for use

  • hypervitaminosis D;

  • hypercalcemia;

  • hypercalciuria;

  • urolithiasis (the formation of calcium oxalate stones in the kidneys);

  • sarcoidosis;

  • acute and chronic diseases of the liver and kidneys;

  • renal failure;

  • active form of pulmonary tuberculosis;

  • hypersensitivity to the components of the drug (especially to benzyl alcohol).

The drug should be used with caution in patients in a state of immobilization; when taking thiazides, cardiac glycosides (especially digitalis glycosides); during pregnancy and lactation (breastfeeding); in infants with a predisposition to early overgrowth of fontanelles (when the small size of the anterior fontanelle is established from birth).

Application during pregnancy and lactation

During pregnancy, vitamin D3 should not be used in high doses due to the possibility of teratogenic effects in case of overdose.

Vitamin D3 should be prescribed with caution during lactation, because when using the drug in high doses in a nursing mother, overdose symptoms may develop in a child.

Application for violations of liver function

Contraindicated in acute and chronic liver diseases.

Application for impaired renal function

Contraindicated in acute and chronic kidney disease; with renal failure.

Application in children

With caution: in infants with a predisposition to early overgrowth of fontanelles (when the small size of the anterior fontanelle is established from birth).

special instructions

Overdose should be avoided.

The individual provision of a specific need should take into account all possible sources of this vitamin.

Too high doses of vitamin D3 taken for a long time or loading doses can cause chronic hypervitaminosis D3.

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

Upon 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 AquadetrimЃ at a dose of 1500-2000 IU (3-4 drops) / day.

Do not use high doses of calcium together with vitamin D3.

During treatment, periodic monitoring of the concentration of phosphates in the blood and urine is necessary.

ѕри длительном приеме колекальциферола необходимо регул¤рно определ¤ть уровень кальци¤ в сыворотке крови и моче, а также оценивать функцию почек путем измерени¤ сывороточного уровн¤ креатинина. ѕри необходимости, следует корректировать дозу колекальциферола в зависимости от уровн¤ кальци¤ в сыворотке крови.

ѕередозировка

—имптомы: снижение аппетита, тошнота, рвота, запор, беспокойство, жажда, полиури¤, диаре¤, кишечна¤ колика. „астыми симптомами ¤вл¤ютс¤ головна¤, мышечна¤ и суставна¤ боли, нарушени¤ психики, в т.ч. депресси¤, атакси¤, ступор, прогрессирующа¤ потер¤ массы тела. –азвиваетс¤ нарушение функции почек с альбуминурией, эритроцитурией и полиурией, повышенной потерей кали¤, гипостенурией, никтурией и повышением ј?.

¬ т¤желых случа¤х возможно помутнение роговицы, реже - отек сосочка зрительного нерва, воспаление радужной оболочки вплоть до развити¤ катаракты. ¬озможно образование камней в почках, кальцификаци¤ м¤гких тканей, в т.ч. кровеносных сосудов, сердца, легких, кожи.

–едко развиваетс¤ холестатическа¤ желтуха.

Ћечение: отмена препарата. Ќазначают прием большого количества жидкости. ѕри необходимости может потребоватьс¤ госпитализаци¤.

Ћекарственное взаимодействие

ѕротивоэпилептические средства, рифампицин, колестирамин снижают реабсорбцию витамина D3.

ѕрименение одновременно с тиазидными диуретиками повышает риск про¤влени¤ гиперкальциемии.

ќдновременное применение с сердечными гликозидами может усиливать их токсическое действие (повышаетс¤ риск про¤влени¤ нарушений ритма сердца).

”слови¤ хранени¤

The drug should be stored in its original packaging out of the reach of children at a temperature not exceeding 25 ? C.

Shelf life

Shelf life is 3 years. Do not use after the expiration date.

Terms of sale

The drug is dispensed without a prescription.

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