Akvadetrim soluble tablets 500ME, No. 60

• Prevention and treatment of rickets,

• spasmophilia,

• osteomalacia of various origins,

• metabolic osteopathies (hypoparathyroidism, pseudohypoparathyroidism),

• hypocalcemic tetany.

Inside.

Dissolve the tablet in water at room temperature (the amount of water is at least 15 ml - 1 tablespoon). It takes some time for the tablet to dissolve (about 1-2 minutes). Unless otherwise prescribed by the doctor, the drug is used in the following dosages:

Prophylactic doses:

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

Premature babies from 4 weeks of age, twins, infants in poor living conditions: 1000-1500 ME (2-3 tablets) per day.

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

in healthy adults without malabsorption: 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 1000 IU (2 tablets) per day, starting from the 28th week of pregnancy.

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

Therapeutic doses:

With rickets: daily 1000-5000 ME (2-10 tablets), depending on the severity of rickets (I, II, or III) and the course of the course, for 4-6 weeks, under close monitoring of the clinical condition and the study of biochemical parameters (calcium, phosphorus, alkaline phosphatase) blood and urine. You should start with 1000 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.

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 a transition to a prophylactic dose of 500-1500 IU per day.

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

To maintain an adequate level of vitamin D concentration in the blood (> 30 ng / ml 25 (OH) D) - 2000 ME (4 tablets) per day.

The dosage is usually based on the amount of vitamin D taken from the diet.

Side effect

Symptoms caused by hypercalcemia and / or hypercalciuria are most likely with hypersensitivity to cholecalciferol and overdose: anorexia, nausea, vomiting, headache, cardiac dysfunction, muscle and joint pain, weakness, irritability, depression, weight loss, severe thirst, polyuria , formation of kidney stones, nephrocalcinosis, soft tissue calcification.

Vitamin D3 100 SD / S dry - 5 mg, corresponds to colecalciferol - 500 IU,

Excipients : D, L -? - tocopherol, modified starch, sucrose, crystalline sodium ascorbate, medium chain triglycerides, silicon dioxide, mannitol, sodium benzoate.

• hypersensitivity to drug components;

• hypervitaminosis D;

• increased concentration of calcium in the blood (hypercalcemia);

• increased excretion of calcium in the urine (hypercalciuria);

• urolithiasis (the 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.

Pharmaco-therapeutic group: Vitamin

pharmachologic effect

Vitamin D3, regulator of calcium and phosphorus metabolism. Strengthens the absorption of calcium in the intestine and the reabsorption of phosphorus in the renal tubules.

Promotes the formation of the bone skeleton and teeth in children, the preservation of bone structure.

It is necessary for the normal functioning of the parathyroid glands. Participates in the synthesis of lymphokines and ATP.

Pharmacokinetics

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

T1 / 2 is several days. It is excreted in urine and feces.

If the function is impaired, T1 / 2 may increase.

Penetrates the placental barrier. Excreted in breast milk.

Indications

• Prevention and treatment of rickets,

• spasmophilia,

• osteomalacia of various origins,

• metabolic osteopathies (hypoparathyroidism, pseudohypoparathyroidism),

• hypocalcemic tetany.

Method of administration and dosage:

Inside.

Dissolve the tablet in water at room temperature (the amount of water is at least 15 ml - 1 tablespoon). It takes some time for the tablet to dissolve (about 1-2 minutes). Unless otherwise prescribed by the doctor, the drug is used in the following dosages:

Prophylactic doses:

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

Premature babies from 4 weeks of age, twins, infants in poor living conditions: 1000-1500 ME (2-3 tablets) per day.

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

in healthy adults without malabsorption: 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 1000 IU (2 tablets) per day, starting from the 28th week of pregnancy.

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

Therapeutic doses:

With rickets: daily 1000-5000 ME (2-10 tablets), depending on the severity of rickets (I, II, or III) and the course of the course, for 4-6 weeks, under close monitoring of the clinical condition and the study of biochemical parameters (calcium, phosphorus, alkaline phosphatase) blood and urine. You should start with 1000 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.

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 a transition to a prophylactic dose of 500-1500 IU per day.

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

To maintain an adequate level of vitamin D concentration in the blood (> 30 ng / ml 25 (OH) D) - 2000 ME (4 tablets) per day.

The dosage is usually based on the amount of vitamin D taken from the diet.

Side effect

Symptoms caused by hypercalcemia and / or hypercalciuria are most likely with hypersensitivity to cholecalciferol and overdose: anorexia, nausea, vomiting, headache, cardiac dysfunction, muscle and joint pain, weakness, irritability, depression, weight loss, severe thirst, polyuria , formation of kidney stones, nephrocalcinosis, soft tissue calcification.

Contraindications for use

• hypersensitivity to drug components;

• hypervitaminosis D;

• increased concentration of calcium in the blood (hypercalcemia);

• increased excretion of calcium in the urine (hypercalciuria);

• urolithiasis (the 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.

Application during pregnancy and lactation

Should not be used in high doses during pregnancy.

When used in a high dose in a nursing mother, overdose symptoms may develop in a child.

Application for impaired renal function

Contraindicated in renal failure.

Application in children

When used in children, it is not recommended to exceed the dose of 400,000-600,000 IU per year. For children in conditions of increased insolation, one-time and, accordingly, the course dose should be reduced.

Use in elderly patients

Use with caution in elderly patients.

special instructions

Can be used in combination with calcium carbonate.

It is used with caution in elderly patients, as well as in patients with prolonged immobilization.

When used in children, it is not recommended to exceed the dose of 400,000-600,000 IU per year. For children in conditions of increased insolation, one-time and, accordingly, the course dose should be reduced.

With simultaneous use with thiazide diuretics, the level of calcium in the blood and urine should be monitored every 3-6 months.

Drug interactions

With simultaneous use with anticonvulsants, rifampicin, cholestyramine, the absorption of cholecalciferol decreases.

With simultaneous use with cardiac glycosides, the toxic effect of cardiac glycosides may increase (the risk of developing cardiac arrhythmias increases).

With simultaneous use with thiazide diuretics, the risk of developing hypercalcemia increases.

Conditions of dispensing from pharmacies

Without recipe

Storage conditions

At a temperature not exceeding 25 ? C, in its original packaging.

Keep out of the reach of children.