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Composition

active ingredients: 1 tablet contains


a-Ketoisoleucine, calcium salt

a-Ketoleucine, calcium salt

a-Ketophenylalanine, calcium salt

a-Ketovalin, calcium salt

a-Hydroxymethionine, calcium salt

Lysine acetate,

which corresponds to 75 mg of lysine

Threonine

Tryptophan

Histidine

Tyrosine

 

67 mg

101 mg

68 mg

86 mg

59 mg

 

105 mg

53 mg

23 mg

38 mg

30 mg;

Total nitrogen content per tablet

Calcium content per tablet

 

36 mg

1.25 mmol = 50 mg

excipients: corn starch, crospovidone, talc, colloidal anhydrous Silicon Dioxide, Magnesium Stearate, polyethylene Glycols (macrogols), Quinoline yellow (E 104), acrylate copolymer, triacetin, titanium dioxide (E 171), povidone.

Dosage form

Film-coated tablets.


Basic physical and chemical properties: yellow tablets with a glossy surface.


Pharmacotherapeutic group

Amino acids, including combinations with polypeptides.


ATX code V06D D.


Pharmacological properties

Pharmacodynamics.


Ketosteril is a combination drug for the treatment of renal failure containing ketone analogues of amino acids. Improves nitrogen metabolism, promotes protein anabolism, reduces the severity of uremic symptoms, and improves the condition of patients with chronic kidney disease.


After absorption, ketoanalogs are transaminated to the corresponding essential amino acids by absorbing nitrogen from the essential amino acids, thereby reducing urea formation by reusing the amino group. The drug promotes the utilization of nitrogen-containing metabolic products.


Ketosteril in combination with a low-protein diet reduces nitrogen intake, while preventing the harmful effects of insufficient dietary protein intake and malnutrition, and provides the body with essential amino acids with minimal nitrogen administration. Ketone analogues of essential amino acids that make up the preparation provide a full-fledged Substrate support for protein synthesis.


Keto / amino acids do not cause hyperfiltration of residual nephrons. Ketosteril improves nitrogen metabolism, reduces the concentration of potassium, magnesium and phosphate ions in the blood, which has a positive effect in renal hyperphosphatemia and secondary hyperparathyroidism.


With the systematic use of Ketosteril, there was an improvement in the condition of patients with chronic renal failure. In some cases, the use of Ketosteril contributes to the latest start of dialysis.


Pharmacokinetics.


The plasma kinetics of amino acids and their integration into metabolic pathways are well known. In patients with uremia, the cause of changes in plasma amino acid levels, which are often observed, is not the absorption of the supplied amino acids, that is, the absorption itself is not disrupted. Altered plasma levels associated with impaired Kinetics after uptake can be detected at a very early stage of the disease.


In healthy individuals, plasma keto acid levels increase within 10 minutes of oral administration. A maximum 5-fold increase in basic levels is achieved. Peak levels are observed for 20-60 minutes, and after 90 minutes, levels stabilize in the range of baseline levels. Thus, gastrointestinal absorption is very fast. Simultaneous increases in the levels of keto acids and related amino acids show that keto acids are transaminated very quickly. Due to the physiological pathways of keto acid utilization in the body, it is likely that exogenous keto acids are very quickly integrated into metabolic cycles. Keto acids follow the same catabolic pathways as classical amino acids. No specific studies of keto acid elimination have yet been conducted.


Indications

Prevention and treatment of disorders that are caused by altered or insufficient protein metabolism in chronic renal failure, in combination with limited protein intake with food up to 40 g per day (for adults) or less. Use in patients with a glomerular filtration rate (GFR) of less than 25 ml/min.


Contraindications

Hypersensitivity to the components of the drug. Hypercalcemia, a violation of amino acid metabolism.


Interactions with other drugs and other types of interactions

Concomitant administration of calcium-containing medications can lead to increased serum calcium levels.


Medications that form hard-to-dissolve compounds with calcium, such as tetracyclines, quinolines such as ciprofloxacin and norfloxacin, as well as medications containing iron, fluorine or Estramustine, should not be taken simultaneously with Ketosteril to avoid malabsorption of active substances, so at least two hours should pass between taking Ketosteril and these drugs.


Susceptibility to cardioactive glycosides and, consequently, the risk of arrhythmia increases if Ketosteril causes an increase in serum calcium levels. During treatment with Ketosteril, the symptoms of uremia decrease. Therefore, it is also necessary to reduce the possible introduction of aluminum hydroxide. It is necessary to monitor the decrease in the level of phosphate in the blood serum.


Application features

It is necessary to regularly monitor the level of calcium in the blood serum.


Ketosteril should be taken with a meal for better absorption and conversion to the appropriate amino acids. It is necessary to provide sufficient caloric content of food, about 30-40 kcal/kg/day.


In case of hereditary phenylketonuria, it should be borne in mind that the drug contains phenylalanine.


In accordance with the degree of reduction of uremic symptoms under the influence of Ketosteril, the dose of simultaneously prescribed aluminum hydroxide should be reduced.


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


Use during pregnancy or lactation.


There is insufficient experience in using Ketosteril during pregnancy and lactation. Reproductive toxicity studies do not indicate direct or indirect harmful effects on pregnancy, fetal development, childbirth, or the postpartum period. Use with caution during pregnancy.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


It doesn't affect you.


Dosage and administration

The drug is used orally. Unless otherwise prescribed, Ketosteril is taken at the rate of 1 tablet per 5 kg of body weight/day (0.1 g/kg of body weight per day), or 4-8 tablets (the dose is calculated for a patient with a body weight of 70 kg) 3 times a day with meals.


Tablets are swallowed without chewing. Ketosteril is prescribed simultaneously with a low-protein diet (protein restriction in the diet) of 40 g per day or less.


Children. There is no experience of using it in children, so the drug is not recommended for use in this category of patients.


Overdose

There are no reports of overdose cases.


Side effects

Adverse reactions by frequency are estimated as follows: very common (≥ 1/10), common (> 1/100, < 1/10), non-common (> 1/1000, < 1/100), rarely common (> 1/10, 000, < 1/1000), very rarely common (< 1/10, 000).


Metabolic disorders: very rarely common – hypercalcemia.


If hypercalcemia occurs, the dose of vitamin D should be reduced. If hypercalcemia persists, it is necessary to reduce the dose of Ketosteril, as well as other sources of calcium.


People with hypersensitivity may develop allergic reactions.


Expiration date

3 years.


Storage conditions

Store in the original packaging to protect from moisture at a temperature not exceeding 25 ° C.


Keep out of reach of children.

Tags: Ketosteril