2 October

Ketosteril - instructions for use , indications, dosage

Ketosteril - combined means of ketone analogs of amino acids, used for kidney failure.

release form and composition

dosage form - tablets, film-coated: oblong biconvex shape, yellow (20 pieces in blister, 5 blisters soldered into packages of PVC, in a cardboard bundle one package.).

Ketosterila The content of active substances in 1 tablet:

  • Leucine alpha ketoanalog (methyl-4-oxo-2-calcium valerinat) - 101 mg;
  • alpha ketoanalog isoleucine (DL-methyl-2-oxo-calcium valerinat) - 67 mg;
  • ketoanalog alpha-Phenylalanine (2-oxo-3-phenyl-propionate, calcium) - 68 mg;
  • Valine alpha ketoanalog (methyl-2-oxo-butyrate, calcium) - 86 mg;Methionine
  • alpha-hydroxy analog (DL-hydroxy-2-methylbutyrate calcium) - 59 mg;
  • L-threonine - 53 mg;
  • L-lysine monoacetate - 105 mg;
  • L-tryptophan - 23 mg;
  • L-tyrosine - 30 mg;
  • L-histidine - 38 mg.

Auxiliary ingredients: povidone, corn starch, colloidal silicon dioxide, macrogol 6000, magnesium stearate, povidone, soluble, talc.

shell Ingredients: macrogol 6000, methyl m

ethacrylate copolymer, butyl methacrylate and dimethylaminoethyl methacrylate (Eudragit E12.5), triacetin, titanium dioxide, talc, quinoline yellow (E104).

total nitrogen content - 36 mg Calcium - 50 mg.

Indications

Application Ketosterila indicated for the prevention and treatment of malnutrition, occurred against the backdrop of the altered protein metabolism in patients with restricted protein diet and chronic renal failure.

Ketosteril primarily for patients with glomerular filtration rate of less than 25 ml / min, but the drug can be taken at the glomerular filtration rate of 25 ml / min or more.

Contraindications

  • Violation of amino acid metabolism;
  • hypercalcemia;
  • period of pregnancy and breastfeeding (because of the lack of clinical application experience);
  • Age up to 3 years;
  • hypersensitivity to the drug.

In appointing patients with hereditary phenylketonuria should take into account the content of phenylalanine in the preparation.

Dosage and Administration

Ketosteril taken orally, while eating, swallowing without chewing tablets.

dose of the drug prescribed by the physician based on clinical indications, taking into account the patient's weight.

recommended dosing regimen for patients older than 3 years: the rate of 1 tablet per 5 kg body weight per day or 100 mg per 1 kg of body weight per day.Typically, when 70 kg of body weight dose is 4-8 tablets three times a day.

The drug should be continued throughout the period, while the glomerular filtration rate below 25 ml / min.

recommended protein content in food:

  • Children 3-10 years: 1,4-0,8 g per 1 kg of body weight per day;
  • Older than 10 years: 1-0,6 g per 1 kg of body weight per day.

Given the degree of chronic renal failure patients on dialysis in the predialysis period, the protein content of the diet should not exceed 40 grams per day, in the intervals between treatments the rate of protein intake should strictly comply with the recommendations.

Side effects

Against the background of Ketosterila in some cases may develop hypercalcemia.

Cautions

used vitamin D dose If hypercalcemia is recommended to reduce, if this measure is not sufficient, it is necessary to reduce the dose Ketosterila and other calcium-containing products.

Treatment should be accompanied by regular monitoring of calcium and reducing the level of phosphate concentration in the serum.

Taking the drug during meals improves absorption and conversion to the corresponding amino acids.

Throughout the patient's treatment should be provided with sufficient food calorie.

If hypersensitivity to the drug may develop allergic reactions.

Drug Interactions

dose simultaneously used aluminum hydroxide is recommended to decrease with decreasing under the influence Ketosterila uremic symptoms.

necessary to control the degree of decrease in serum phosphate content.

interval must be observed for at least two hours between taking drugs and Ketosterila forming calcium sparingly soluble compounds, including quinolones, tetracyclines, iron supplements, estramustine, fluorine (it will not break the absorption in the intestine).

Terms and conditions of storage

Keep away from children.

Store in a dark, dry place at temperatures up to 25 ° C.

Shelf life - 3 years.

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