Expiration date: 01/2025

The composition and form of issue:

Tablets, film-coated. 1 tablet contains active ingredients: 

isoleucine alpha ketoanalogue (DL-methyl-oxo-2-calcium valerenal) 67 mg

leucine alpha ketoanalogue (methyl-4-oxo-2-valerina calcium) 101 mg

phenylalanine alpha-ketoanalogue (oxo-2-phenyl-3-calcium propionate) 68 mg

valine alpha-ketoanalogue (methyl-oxo-2-calcium butyrate) 86 mg

methionine alpha hydroxyanisol (DL-hydroxy-2-calcium methylbutyrate) 59 mg

L-lysine 105 mg monoacetate

L-threonine 53 mg

L-tryptophan 23 mg

L-histidine 38 mg

L-tyrosine 30 mg

other ingredients: corn starch — 44 mg povidone 6 mg talc — 19,57 mg silica colloidal anhydrous — 4.4 mg magnesium stearate 15 mg macrogol 6000 — 12.8 mg povidone soluble — 43,2 mg 

shell tablets: talc — 9.1 mg macrogol 6000 — 1,48 mg quinoline yellow (E104) — 0.72 mg of methyl methacrylate, dimethylaminoethylmethacrylate and butylmethacrylate copolymer (Eudragit E12,5) — 5,9 mg triacetin and 0.43 mg of titanium dioxide — 7.4 mg 

total nitrogen content in the tablet 36 mg

the calcium content in the tablet (1.25 mmol) of 50 mg

blistere in 20 PCs in sealed package 5 blisters per cardboard pack 1 package.

Description pharmaceutical form:

Oblong, biconvex tablets with yellow coating.

Description pharmacological action:

A combination drug. Provides a complete supply of essential amino acids with minimal nitrogen. Ketone analogs of amino acids in the body enzymatic transaminases to the corresponding L-amino acids by breaking down the urea. The drug promotes recycling nitrogenous products of metabolism, anabolism of proteins while reducing concentrations of urea in serum. Improves nitrogen metabolism. Reduces the concentration in blood of ions of potassium, magnesium and phosphate. The systematic use of the drug has seen an improvement in the patients with chronic renal failure. In some cases, can delay the initiation of dialysis.

Indications:

Protein-energy malnutrition, prevention and treatment of disorders in adults and children from 3 years, caused by altered protein metabolism in chronic renal insufficiency, and in the limitation of protein in the diet. Mainly used in patients with chronic renal insufficiency with glomerular filtration rate below 25 ml/min, which does not exclude the application when the glomerular filtration rate and higher than 25 ml/min.

Contraindications:

• hypersensitivity
  
• the metabolism of amino acids
  
• hypercalcemia.
  

When hereditary phenylketonuria should be aware that the product contains phenylalanine.

Application of pregnancy and breast-feeding:

Insufficient experience of use in pregnancy and lactation.

Side effects:

In some cases, may develop hypercalcemia. It is recommended to reduce the intake of vitamin D. If hypercalcaemia persists, reduce the dose Ketosteril and other sources of calcium.

Drug interactions:

The simultaneous appointment of drugs, containing calcium, can lead to increased levels of calcium in blood serum. Decreasing uremic symptoms under the influence of Ketosteril dose at the same time designated aluminum hydroxide should be reduced accordingly. Should monitor the level of phosphate in blood serum.

In order not to violate the absorption in the intestine, should not be taken together with Ketosteril BOS, capable of forming with soluble calcium compounds (e.g. tetracyclines, chinolone preparations containing iron, fluorine and estramustin). Between taking ketosteril and similar drugs should be spaced at least 2 hours.

Method of application and dose:

nside, while eating, not chewing. Adults and children from 3 years — 1 table. 5 kg of body weight per day or 0.1 g/kg/day. Unless otherwise directed, take 3 times a day.

Duration of use: Ketosteril appointed during the period when the glomerular filtration rate below 25 ml/min. In the predialysis period recommended content in food protein is not more than 40 g per day (depending on the degree of chronic renal failure). Patients on dialysis protein intake must conform to accepted standards.

The usual dose for an adult (body weight 70 kg) is 4-8 table. 3 times a day. The usual dose for children is 1 tab. 5 kg of body weight per day.

The recommended protein content of meals for children 3-10 years — 1,4–0,8 g/kg/day, from 10 years old — 1-0,6 g/kg/day.

Special instructions:

Ketosteril should be taken with food for best absorption and conversion into the corresponding amino acids.

You should regularly monitor the level of calcium in the blood serum. Need to ensure adequate calorie intake.

In some cases, may cause allergic reactions in patients with hypersensitivity to the drug.