Aquadetrim - instructions for use, dose, side effects, contraindications

Excipients: macrogol glycerylricinoleate, sucrose, sodium hydrophosphate dodecahydrate, citric acid monohydrate, flavoring anise, benzyl alcohol, purified water.

Description:

Colorless, clear or slightly opalescent liquid with aniseed odor.

Pharmacotherapeutic group:Calcium-phosphorus exchange regulator

ATX: & nbsp

A.11.C.C.05 Kolekaltsiferol

Pharmacodynamics:

Vitamin D₃is an active antirachitic factor. The most important function of the vitamin D₃ is the regulation of the metabolism of calcium and phosphate, which contributes to the proper mineralization and growth of the skeleton.

Vitamin D₃ is a natural form of vitamin D, which is formed in a person in the skin under the influence of sunlight. Compared with vitamin A D₂ is characterized by 25% higher activity. Kolekaltsiferol plays an essential role in the absorption of calcium and phosphate from the intestine, in the transport of mineral salts and in the process of calcification of bones, also regulates the excretion of calcium and phosphateat kidneys. The concentration of calcium ions in the blood causes the maintenance of muscle tone of skeletal muscles, the function of the myocardium, promotes the conduction of nervous excitement, regulates the process of blood coagulation. Vitamin D is necessary for the normal function of the parathyroid gland, also participates in the functioning of the immune system, affecting the production of lymphokines.

Lack of Vitamin D in the diet, impaired absorption, calcium deficiency, as well as insufficient exposure to sunlight, during intensive growth of the child, leads to rickets, in adults to osteomalacia, in pregnant women symptoms of tetany, disturbance of processes of calcification of bone tissue of newborns may occur. Increased need for a vitamin D occurs in women during the menopause, because they often develop osteoporosis, due to hormonal disorders.

Pharmacokinetics:

An aqueous solution of a vitamin D₃ absorbed better than the oil solution. In premature infants, there is insufficient formation and the supply of bile to the intestine, which disrupts the absorption of vitamins in the form of oily solutions.

After oral administration colcalciferol absorbed in the small intestine. Metabolised in the liver and kidneys. The half-life of colcalciferol from the blood is several days and can last for 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 possesses the cumulation property.

Indications:

Prevention and treatment of vitamin deficiency D.

Prophylaxis and treatment of rickets, rachitis-like diseases, hypocalcemic tetany, osteomalacia and bone diseases on a metabolic basis (such as hypoparathyroidism and pseudohypoparathyroidism).

In the complex treatment of osteoporosis, including postmenopausal.

Contraindications:Hypersensitivity to the components of the drug, especially benzene alcohol. Hypervitaminosis D, elevated calcium concentration in the blood (hypercalcemia), increased calcium excretion in the urine (hypercalciuria), urolithiasis (formation of calcium oxalate stones), sarcoidosis, acute and chronic liver and kidney disease, renal failure, active form of pulmonary tuberculosis. Children up to 4 weeks of life.

Carefully:

FROMthe state of immobilization, with the use of thiazides, cardiac glycosides (especially the digitalis glycosides); during pregnancy and breastfeeding.

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

Pregnancy and lactation:

During pregnancy, do not use a vitamin D₃ in high doses because of the possibility of teratogenicity in case of an overdose.

Caution should be prescribed vitamin D₃ in women breastfeeding - a drug taken in high doses by the mother, can cause symptoms of an overdose in a child.

During pregnancy and breastfeeding, the dose of the vitamin D₃ should not exceed 600 ME per day.

Dosing and Administration:

Orally.

The drug should be taken in a spoonful of liquid.

1 drop contains about 500 ME vitamin A D₃.

If the doctor has not prescribed otherwise, the drug is used in the following dosages:

Prophylactic doses:

- term infants from 4 weeks of life, up to 2-3 years with proper care and sufficient stay in the open air: 500 - 1000 ME (1-2 drops) per day;

- premature babies, from 4 weeks of life, twins, infants in poor living conditions: 1000 - 1500 ME (2-3 drops) per day. In the summer, you can limit the dose to 500 ME (1 drop) per day.

- pregnant women: daily dose 500 ME (1 drop) of the vitamin D3 for the duration of the entire gestation period, or intake of 1000 ME (2 drops) per day starting from the 28th week of pregnancy.

- in the postmenopausal period 500 - 1000 ME (1-2 drops) per day.

Therapeutic doses:

- with rickets: daily 2000 - 5000 ME (4-10 drops), depending on the severity of rickets (I, II, or III) and the flow variant, 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. Beginning from 2000 ME within 3-5 days. Then, with good tolerability, the dose is raised to an individual treatment dose (usually 3000 ME). The dose of 5000 ME is prescribed only with pronounced bone changes.

As necessary, after one week break, you can repeat the course of treatment. Treatment is carried out until a clear therapeutic effect, followed by a transition to a prophylactic dose of 500 - 1500 ME per day.

- in the treatment of ricket-like diseases: 20 000 - 30 000 ME per day (40 - 60 drops) depending on the age, weight and severity of the disease, under the control of biochemical blood indices and urinalysis. The course of treatment is 4-6 weeks. Treatment is carried out under the supervision of a doctor.

- in the complex treatment of postmenopausal osteoporosis: 500 - 1000 ME (1-2 drops) per day.

Dosage, as a rule, is prescribed taking into account the amount of vitamin D, coming from food.

Side effects:

Hypersensitivity to the components of the drug, hypervitaminosis D (symptoms of hypervitaminosis: loss of appetite, nausea, vomiting, headaches, muscle and joint pains, constipation, dry mouth, polyuria, weakness, mental disorders, including depression, weight loss, sleep disturbance, fever, urine appears protein, leukocytes, hyaline cylinders, increase in the level of calcium in the blood and its excretion in the urine, calcification of the kidneys, blood vessels, lungs is possible).

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

Overdose:

Symptoms of an overdose: decreased 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. Developmental disorders of kidney function with albinuria, erythrocyte and polyuria, increased loss of potassium, hypostenuria, nicturia and increased blood pressure. In severe cases, corneal opacity may occur, less often the swelling of the optic nerve papilla, inflammation of the iris until cataracts develop. Kidney stones can form, the process of calcification of soft tissues, including blood vessels, heart, lungs and skin, occurs. Rarely develops cholestatic jaundice.

Treatment

Interrupt the use of the drug. Seek medical advice. Take plenty of fluids. If necessary, hospitalization may be required.

Interaction:

Antiepileptic agents, rifampicin, colestramine reduce the reabsorption of the vitamin D₃.

Application simultaneously with thiazide diuretics increases the risk of hypercalcemia.

Simultaneous use with cardiac glycosides can enhance their toxic effects (the risk of cardiac rhythm disturbances increases).

Special instructions:

Avoid overdose.

Individual provision of a specific need should consider all possible sources of this vitamin.

Too high doses of vitamin A D₃, long-acting or shock doses may cause chronic hypervitaminosis D₃.

Determination of the daily requirement of a child in vitamin D and the method of its application should be established by the doctor individually and each time be corrected during periodic examinations, especially in the first months of life.

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

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

Form release / dosage:

Drops for ingestion 15 000 IU / ml.

Packaging:To 10 ml in bottles of dark glass with a plastic stopper-dropper and a screwed polyethylene cover with a warranty ring "first opening." 1 The bottle together with the instruction for use is placed in a cardboard box.

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C. Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:Without recipe

Registration number:П N014088 / 01

Date of registration:06.10.2008

Expiration Date:Unlimited

The owner of the registration certificate:Medan Pharma, Joint Stock CompanyMedan Pharma, Joint Stock Company Poland

Manufacturer: & nbsp

MEDANA PHARMA TERPOL GROUP, S.A. Poland

Representation: & nbspAKRIKHIN OJSC AKRIKHIN OJSC Russia

Information update date: & nbsp24.06.2017

Illustrated instructions

Instructions

Aquadetry® (Aquadetrim)