Aquadetrim (Colecalciferol) drops for oral administration 15000 IU / ml vial. 10ml

Release form, composition and packaging

?

Drops for oral administration are colorless, transparent or slightly opalescent, with an aniseed odor.

1 ml (30 drops)

colecalciferol (vit. D3) 15,000 IU

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

10 ml - dark glass dropper bottles (1) - cardboard packs.

15 ml - dark glass dropper bottles (1) - cardboard packs.

pharmachologic effect

Vitamin D3 is an active antirachitic factor. The most important function of vitamin D is to regulate calcium and phosphate metabolism, which promotes skeletal mineralization and growth. Vitamin D3 is a natural form of vitamin D that is produced in humans in the skin by exposure to sunlight. Compared to vitamin D2, it is characterized by 25% higher activity. Colecalciferol plays an essential 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 in physiological concentrations ensures the maintenance of muscle tone of the skeletal muscles, myocardial function, promotes the conduction of nervous excitement, and regulates the process of blood coagulation.Vitamin D is essential for the normal functioning of the parathyroid glands, and is also involved in the functioning of the immune system, affecting the production of lymphokines. 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 tetany symptoms, 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.as well as insufficient exposure to the sun during the period of rapid growth of the child leads to rickets, in adults - to osteomalacia, in pregnant women, symptoms of tetany may occur, a violation of the processes of 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.as well as insufficient exposure to the sun during the period of rapid growth of the child leads to rickets, in adults - to osteomalacia, in pregnant women, symptoms of tetany may occur, a violation of the processes of 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.

Pharmacokinetics

Absorption An aqueous solution of colecalciferol is absorbed better than an oil solution (this is important when used in premature babies, since 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 Metabolized in the liver and kidneys.

Penetrates the placental barrier.

Excreted in breast milk.

Colecalciferol accumulates in the body.

Removal of T1 / 2 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 for use

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).

Contraindications for use

- hypervitaminosis D

- hypercalcemia

- hypercalciuria

- urolithiasis (the formation of calcium oxalate stones in the kidneys)

- sarcoidosis

- acute and chronic kidney disease

- renal failure

- active form of pulmonary tuberculosis

- children's age up to 4 weeks

- hypersensitivity to vitamin D3 and other 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

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).

Dosage regimen

Prep

Name ENG

AQUADETRIM

Clinical and pharmacological group

A drug that regulates the exchange of calcium and phosphorus

ATX code

Colecalciferol

Dosage

15000IU / ml x 10ml

Structure

1 ml of solution (30 drops) contains Colecalciferol (Vitamin D3) - 15,000 ME.

excipients: macrogol glyceryl ricinoleate, sucrose, sodium hydrogen phosphate dodecahydrate, citric acid monohydrate, anise flavor (or anise essence), gasoline alcohol, purified water.

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).

INN / Active ingredient

Colecalciferol

Storage conditions and periods

At a temperature not exceeding 25 degrees, in the original packaging.

Expiration date: 3 years

Contraindications

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).

Specifications

Category

Vitamin and mineral complexes

Scope of the medicinal product

Vitamins

Release form

Drops

Manufacturer country

Poland

Package quantity, pcs

one

Way of introduction

Through the mouth

Vacation conditions

Without recipe

Volume, ml.

10 ml

Brand name

Akrikhin

The amount of the dosage form in the primary package

10 ml

Primary packaging type

Dropper bottle

Type of consumer packaging

Pack of cardboard

Pharmaco-therapeutic group

Calcium-phosphorus metabolism regulator

Anatomical and therapeutic characteristics

A11CC05 Colecalciferol

Dosage form

Drops for oral administration

Expiration date in days

1095

Dosage (volume) of the substance in the preparation

15,000 IU

Package weight, g

thirty

Mode of application

:

Orally. < br> Dissolve Aquadetrim in 1 spoonful of liquid. < br> 1 drop contains about 500 IU of vitamin D3. < br> Unless the doctor prescribes otherwise, the drug is used in the following dosages: < br> < br> Prophylactic doses: < br> < br> full-term newborns from 4 weeks of age, up to 2-3 years with proper care and sufficient freshness air: 500-1000 ME (1-drops) per day < br> premature babies, from 4 weeks of life, twins, infants in poor living conditions: 1000-1500 (2-3 drops) per day. In the summer, you can limit the dose to 500 IU (1 drop) per day. < br> pregnant women: daily dose of 500 IU of vitamin D3 for the entire period of pregnancy, or 1000 IU / day starting from 28 weeks of pregnancy. < Br > in the postmenopausal period 500-1000 ME (1-2 drops) per day. < br> Therapeutic doses: < br> < br> for rickets: daily 2000 - 5000 ME (4-10 drops), depending on the severity of rickets ( I, II or III) and the variant of the course, for 4-6 weeks, under close monitoring of the clinical condition and the study of biochemical parameters (calcium, phosphorus, alkaline phosphatase) of blood and urine. You should start with 2000 ME for 3-5 days. Then, with good tolerance, the dose is increased to the individual therapeutic dose (most often 3000 IU). A dose of 5000 IU is prescribed only for pronounced bone changes. < br> If necessary, after a one week break, you can repeat the course of treatment. < br> Treatment is carried out until a clear therapeutic effect is obtained,with the subsequent transition to a prophylactic dose of 500 - 1500 IU / day. < br> in the treatment of rickets-like diseases: 20,000-30,000 ME per day (40-60 drops), depending on age, body weight and severity of the disease, under the control of biochemical blood parameters and urine analysis. The course of treatment is 4-6 weeks. Treatment is carried out under the supervision of a physician. < br> in the complex treatment of postmenopausal osteoporosis: 500-1000 ME (1-2 drops) per day. < br> The dosage is usually prescribed taking into account the amount of vitamin D supplied with food.in the complex treatment of postmenopausal osteoporosis: 500-1000 ME (1-2 drops) per day. < br> The dosage is usually prescribed taking into account the amount of vitamin D supplied with food.in the complex treatment of postmenopausal osteoporosis: 500-1000 ME (1-2 drops) per day. < br> The dosage is usually prescribed taking into account the amount of vitamin D supplied with food.

Information on technical characteristics, delivery set, country of manufacture