Кетостерил®

General characteristics. Structure:

Active ingredient: 67 mg of DL - methyl-oxo-2-calcium of a valerinat (an isoleucine α-ketoanalogue), 101 mg of methyl-4-oxo-2-calcium of a valerinat (a leucine α-ketoanalogue), 68 mg of oxo-2-phenyl-3-calcium of a propiona (a phenylalanine α-ketoanalogue), 86 mg of methyl-oxo-2-calcium of butyrate (a valine α-ketoanalogue), 59 mg of DL - methyl butyrate hydroxy-2-calcium (a methionine α-hydroxyanalogue), 105 mg of a L-lysine monoacetate, 53 mg of L-threonine, 23 mg of L-tryptophane, 38 mg of a L-histidine, 30 mg of L-tyrosine. The general content of nitrogen is 36 mg, the content of calcium is 1.25 mmol (50 mg).

Excipients: starch corn, povidone, talc, silicon dioxide colloid, magnesium stearate, macrogoal 6000, povidone soluble.

Structure of a cover: talc, a macrogoal 6000, quinolinic yellow (E104), copolymer of methylmethacrylate, dimethylaminoethylmethacrylate and butylmethacrylate (eudragit E12.5), triacetin, titanium dioxide.

Pharmacological properties:

Pharmacodynamics. The combined drug. Provides full supply with irreplaceable amino acids at the minimum administration of nitrogen. Ketonic analogs of amino acids in an organism transaminirutsya enzymatically in the corresponding L-amino acids, splitting at the same time urea. Drug promotes utilization of nitrogen-containing products of exchange, anabolism of proteins at simultaneous decrease in concentration of urea in serum. Improves a nitrogen metabolism. Reduces concentration in blood of potassium ions, magnesium and phosphate.

At systematic use of drug improvement of a condition of patients with a chronic renal failure is noted. In some cases it is possible to delay the beginning of carrying out dialysis.

Pharmacokinetics. Data on pharmacokinetics of the drug Ketosteril® are not provided.

Indications to use:

— proteinaceous and power insufficiency, prevention and treatment of the disturbances caused by the changed proteinaceous metabolism at a chronic renal failure and at restriction of protein in a diet (at adults and children at the age of 3 years is also more senior).

Preferential for patients with a glomerular filtration rate <25 ml/min. that does not exclude use at a glomerular filtration rate of ≥25 ml/min.

Route of administration and doses:

To adults and children at the age of 3 years is also more senior appoint on 1 tab./5 in kg of mass of bodies/days or 100 mg/kg of mass of bodies/days. For adults with the body weight of 70 kg the dose usually makes 4-8 таб. 3 times/days.

Drug is appointed inside, as a rule, by 3 times/days during food. Tablets should be swallowed, without chewing.

Кетостерил® apply during the entire period when the glomerular filtration rate makes less than 25 ml/min.

During the predialysis period contents in protein food no more than 40 g/days depending on degree of a chronic renal failure is recommended.

At the patients who are on dialysis, consumption of protein has to correspond to the accepted recommendations.

The recommended food protein content for children of 3-10 years - 1.4-0.8 g/kg/days, for children is more senior than 10 years - 1-0.6 g/kg/days.

Features of use:

Use at pregnancy and feeding by a breast. Clinical experience of use of Ketosteril at pregnancy and in the period of a lactation is insufficient.

Use at renal failures. Preferential for patients with a glomerular filtration rate less than 25 ml/min. (however use at a glomerular filtration rate is not excluded more than 25 ml/min.).

Use for children. Use according to indications and in the doses considering age of patients is possible.

Special instructions. At a hypercalcemia it is recommended to reduce a dose of the accepted vitamin D. If the hypercalcemia remains, then it is necessary to reduce a drug Ketosteril® dose, and also other sources of calcium.

It is regularly necessary to control the content of calcium and to control decrease in level of phosphates in blood serum.

Кетостерил® it is necessary to accept during food for improvement of its absorption and transformation into the corresponding amino acids.

It is required to provide the sufficient caloric content of food.

At patients with hypersensitivity to components of drug emergence of allergic reactions is in some cases possible.

Side effects:

From a metabolism: in some cases the hypercalcemia can develop.

Interaction with other medicines:

At co-administration of medicines, calciferous, increase in level of calcium in blood serum is possible.

In process of reduction of uraemic symptoms under the influence of the drug Ketosteril® the dose of at the same time applied aluminum hydroxide should be reduced respectively.

It is necessary to monitor decrease in level of phosphates in blood serum.

Not to break absorption in intestines, it is not necessary to accept along with the drug Ketosteril® medicines which form difficult soluble compounds with calcium (for example, the tetracyclines, hinolona, drugs containing iron, fluorine and estramustinum). Between administration of drug of Ketosteril® and similar drugs there has to be an interval not less than 2 h.

Contraindications:

— hypercalcemia;

— disturbance of exchange of amino acids;

— hypersensitivity to drug components.

At a hereditary fenilketonuriya it is necessary to consider that drug contains phenylalanine.

Overdose:

Data on overdose of the drug Ketosteril® are not provided.

Storage conditions:

Drug should be stored in the unavailable to children, dry, protected from light place at a temperature not above 25 °C. A period of validity - 3 years.

Issue conditions:

According to the recipe

Packaging:

20 pieces - blisters (5) - packages from Al/PVC soldered (1) - packs cardboard.