Ketosteril

Ketosteril – the combined means of ketonic analogs of amino acids applied at a renal failure.

Form of release and structure

Dosage form – tablets, film coated: an oblong biconvex shape, yellow color (on 20 pieces in blisters, on 5 blisters it is soldered in packages from polyvinylchloride, in a cardboard pack 1 package).

Content of active ingredients of Ketosteril in 1 tablet:

• Leucine an alpha ketoanalogue (methyl-4-oxo-2-calcium валеринат) – 101 mg;
• Isoleucine an alpha ketoanalogue (DL - methyl-oxo-2-calcium валеринат) – 67 mg;
• Phenylalanine an alpha ketoanalogue (oxo-2-phenyl-3-calcium propionate) – 68 mg;
• Valine an alpha ketoanalogue (methyl-oxo-2-calcium butyrate) – 86 mg;
• Methionine an alpha hydroxyanalogue (DL - hydroxy-2-calcium methyl butyrate) – 59 mg;
• L-threonine – 53 mg;
• L-lysine monoacetate – 105 mg;
• L-tryptophane – 23 mg;
• L-tyrosine – 30 mg;
• L-histidine – 38 mg.

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

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

The general content of nitrogen – 36 mg, calcium – 50 mg.

Indications to use

Ketosteril's use is shown for prevention and treatment of the proteinaceous and power insufficiency which arose against the background of the changed proteinaceous metabolism at patients with restriction in a diet of protein and a chronic renal failure.

Ketosteril is mainly intended for patients with a glomerular filtration rate less than 25 ml/min., but it is possible to accept drug also at a glomerular filtration rate of 25 ml/min. and more.

Contraindications

• Disturbance of exchange of amino acids;
• Hypercalcemia;
• The period of pregnancy and breastfeeding (due to the lack of clinical experience of use);
• Age up to 3 years;
• Hypersensitivity to drug components.

At appointment as the patient with a hereditary fenilketonuriya it is necessary to consider the content of phenylalanine in drug.

Route of administration and dosage

Ketosteril accept inside, during food, swallowing tablets without chewing.

The dose of drug is appointed by the doctor on the basis of clinical indications taking into account the patient's weight.

The recommended dosing mode for patients is more senior than 3 years: from calculation for 1 tablet on each 5 kg of body weight a day or on 100 mg on 1 kg of weight a day. Usually at the body weight of 70 kg the dose makes 4-8 tablets 3 times a day.

Administration of drug should be continued during the entire period while the glomerular filtration rate is lower than 25 ml/min.

The recommended food protein content:

• Children of 3-10 years: 1,4-0,8 g on 1 kg of weight a day;
• 10 years are more senior: 1-0,6 g on 1 kg of weight a day.

Considering degree of a chronic renal failure at patients on dialysis, in the predialysis period contents in food of protein should not exceed 40 g a day, in breaks between procedures the norm of consumption of protein has to correspond to recommendations strictly.

Side effects

Against the background of Ketosteril's use development of a hypercalcemia is in some cases possible.

Special instructions

At a hypercalcemia the dose of the applied vitamin D is recommended to be lowered if this measure is insufficient, it is necessary to reduce Ketosteril's dose and other kaltsiysoderzhashchy drugs.

Treatment should be accompanied with regular control of content of calcium and decrease in level of concentration of phosphates in blood serum.

Administration of drug during food improves its absorption and transformation into the corresponding amino acids.

Throughout the entire period of treatment of the patient it is necessary to provide with food with sufficient caloric content.

At hypersensitivity to components of drug development of allergic reactions is possible.

Medicinal interaction

The dose of at the same time applied aluminum hydroxide is recommended to be reduced in process of decrease under the influence of Ketosteril of uraemic symptoms.

It is necessary to control extent of decrease in content of phosphates in blood serum.

It is necessary to observe an interval not less than two hours between Ketosteril's reception and medicines forming difficult soluble compounds with calcium including hinolona, tetracyclines, ferriferous drugs, estramustinum, fluorine (it will allow not to break absorption in intestines).

Terms and storage conditions

To protect from children.

To store in the protected from light, dry place at a temperature up to 25 °C.

Period of validity – 3 years.