Compound
Film-coated tablets, 1 tablet contains active ingredients: alpha-keto analogue of isoleucine 67 mg , alpha-keto analogue of leucine 101 mg , alpha-keto analogue of phenylalanine 68 mg , alpha-keto analogue of valine 86 mg , alpha-hydroxy analogue of methionine 59 mg , L- lysine monoacetate 105 mg , L-threonine 53 mg , L-tryptophan 23 mg , L-histidine 38 mg , L-Tyrosine 30 mg .
Excipients: corn starch, polyvinylpyrrolidone , talc, colloidal silicon dioxide, magnesium stearate, polyethylene glycol 6000, soluble polyvinylpyrrolidone.
Shell composition: talc, polyethylene glycol 6000, quinoline yellow, copolymer of methyl methacrylate, dimethylaminoethyl methacrylate and butyl methacrylate, triacetin, titanium dioxide.
Just 1 tablet contains 36 mg of nitrogen and 50 mg of calcium.
Ketosteril 50 mg 100 pcs. film-coated tablets
pharmachologic effect
Kidney failure treatment.
Composition and release form Ketosteril 50 mg 100 pcs. film-coated tablets
Tablets - 1 tablet:
- active ingredients: isoleucine alpha-keto analogue (DL-methyl-oxo-2-calcium valerinate) 67 mg, leucine alpha-keto analogue (methyl-4-oxo-2-calcium valerinate) 101 mg, phenylalanine alpha-keto analogue (oxo-2- phenyl-3-calcium propionate) 68 mg, valine alpha-keto analogue (methyl-oxo-2-calcium butyrate) 86 mg, methionine alpha-hydroxy analogue (DL-hydroxy-2-calcium methylbutyrate) 59 mg, L-lysine monoacetate 105 mg , L-threonine 53 mg, L-tryptophan 23 mg, L-histidium 38 mg, L-tyrosine 30 mg;
- other ingredients: corn starch 44 mg, povidone 6.0 mg, talc 19.57 mg, colloidal silicon dioxide 4.4 mg, magnesium stearate 15.0 mg, macrogol 6000 12.8 mg, soluble povidone 43.2 mg;
- tablet shell: talc 9.1 mg, macrogol 6000 1.48 mg, quinoline yellow (E104) 0.72 mg, methyl methacrylate, dimethylaminoethyl methacrylate and butyl methacrylate copolymer (eudragit E 12.5) 5.9 mg, triacetin 0.43 mg, titanium dioxide 7.4 mg.
The total nitrogen content in the tablet is 36 mg.
The calcium content in the tablet is 1.25 mmol = 50 mg.
20 tablets per Al/PVC blister. 5 blisters in a sealed Al/PVC bag.
1 package in a cardboard box with instructions for use.
Description of the dosage form
Oblong, biconvex tablets, yellow film-coated.
Characteristic
A combined preparation that provides a complete supply of essential amino acids with minimal nitrogen input.
Directions for use and doses
For oral administration.
Adults and children over 3 years old: 1 tablet per 5 kg of body weight per day or 0.1 g/kg of body weight per day. Unless otherwise prescribed, take 3 times daily with meals. Swallow without chewing.
Duration of use. Ketosteril® is prescribed during the entire period when the glomerular filtration rate is below 25 ml/min. During the predialysis period, it is recommended that the protein content in food be no more than 40 g of protein per day, depending on the degree of chronic renal failure. In dialysis patients, protein intake should be in accordance with accepted standards.
The usual dose for an adult (body weight 70 kg) is 4-8 tablets 3 times a day.
The usual dose for children is 1 tablet per 5 kg of body weight per day.
The recommended protein content in food for children from 3 to 10 years old is 1.4-0.8 g/kg body weight per day, for children over 10 years old - 1.0-0.6 g/kg body weight per day.
Pharmacodynamics
Combined drug. Provides a complete supply of essential amino acids with minimal nitrogen input. Ketone analogues of amino acids in the body are enzymatically transaminated into the corresponding L-amino acids, breaking down urea. The drug promotes the utilization of nitrogen-containing metabolic products and protein anabolism while simultaneously reducing the concentration of urea in the serum. Improves nitrogen metabolism. Reduces the concentration of potassium, magnesium and phosphate ions in the blood. With systematic use of the drug, an improvement in the condition of patients with chronic renal failure was noted. In some cases, it is possible to delay the start of dialysis.
Indications for use Ketosteril 50 mg 100 pcs. film-coated tablets
Protein-energy deficiency, prevention and treatment of disorders in adults and children over 3 years of age caused by altered protein metabolism in chronic renal failure and when protein is limited in the diet. It is mainly used in patients with chronic renal failure with a glomerular filtration rate below 25 ml/min, which does not exclude use with a glomerular filtration rate above 25 ml/min.
Contraindications
Hypercalcemia, amino acid metabolism disorder, hypersensitivity.
For hereditary phenylketonuria, it should be taken into account that the drug contains phenylalanine.
Application Ketosteril 50 mg 100 pcs. film-coated tablets during pregnancy and breastfeeding
There is no experience of use during pregnancy.
special instructions
There is insufficient experience with use during pregnancy and lactation.
Ketosteril® should be taken with food for better absorption and conversion into the corresponding amino acids.
Serum calcium levels should be monitored regularly. It is necessary to ensure sufficient caloric content of food.
In some cases, allergic reactions may occur in patients with hypersensitivity to the components of the drug.
Side effects Ketosteril 50 mg 100 pcs. film-coated tablets
In some cases, hypercalcemia may develop. In this case, it is recommended to reduce vitamin D intake. If hypercalcemia persists, reduce the dose of Ketosteril®, as well as other sources of calcium.
Drug interactions
The simultaneous administration of drugs containing calcium may lead to an increase in serum calcium levels. As uremic symptoms decrease under the influence of Ketosteril®, the dose of simultaneously prescribed aluminum hydroxide should be reduced accordingly. Monitor for decreased serum phosphate levels. In order not to interfere with absorption in the intestines, you should not take medications with Ketosteril® that can form poorly soluble compounds with calcium (for example, tetracyclines, quinolones, drugs containing iron, fluorine and estramustine). There should be an interval of at least 2 hours between taking Ketosteril® and similar drugs.
Pharmacodynamics and pharmacokinetics
Ketosteril is a drug that contains essential amino acids, without which the body cannot function properly. It is prescribed for renal dysfunction due to damage to the kidney tissue and a gradual increase in the content of toxic metabolic products, mainly protein, in the blood.
A large amount of residual nitrogen and its components are detected in the blood of patients, which have a toxic effect on the body. Residual nitrogen is a collection of non-protein nitrogen (products of protein metabolism in the blood plasma), consisting of urea, amino acid nitrogen , uric acid, creatine and creatinine.
Violation of protein metabolism leads to the fact that the body does not receive vital amino acids , while poisonous products of protein metabolism accumulate in the blood in large quantities. In order to reduce the toxic load on the body, patients are prescribed a protein-restricted diet, which leads to protein starvation.
Ketosteril supplies the body with essential amino acids (the proteins of the human body are built from them), but the amount of nitrogen supplied is limited. This happens due to the fact that ketosteril contains ketone analogues of amino acids, which are quickly absorbed by the body and contribute to the disposal of toxic products of protein metabolism.
This mechanism of action helps to improve protein and mineral metabolism, and therefore the general condition of the patient.
The pharmacokinetics of the drug has not been studied, since all its components are natural components of metabolism, and it is impossible to trace their movement in the body.
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, keto analogs are transaminated into the corresponding essential L-amino acids by absorbing nitrogen from essential amino acids, thereby reducing the formation of urea by recycling the amino group, promoting the utilization of nitrogen-containing metabolic products.
Ketosteril, when combined with a low protein diet, reduces nitrogen intake while preventing the negative effects of insufficient dietary protein intake and malnutrition and provides the body with essential L-amino acids with minimal nitrogen input. Ketone analogues of essential amino acids included in the drug provide complete 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 phosphorus ions in the blood, which has a positive effect on renal hyperphosphatemia and secondary hyperparathyroidism.
With the systematic use of ketosteril, an improvement in the condition of patients with chronic renal failure was noted. In some cases, the use of ketosteril contributes to the very 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 reason for the changes in plasma amino acid levels that are often observed is not the absorption of the amino acids that are supplied, that is, the absorption process is not impaired. Changes in plasma amino acid levels associated with abnormal post-uptake kinetics can be detected at a very early stage of the disease.
In healthy individuals, the level of ketoacids in the blood plasma increases within 10 minutes after oral administration. A maximum of 5-fold increase in baseline levels is achieved. Peak levels are noted within 20–60 min, and after 90 min levels stabilize within the baseline range. Thus, gastrointestinal absorption is very rapid. The simultaneous increase in the level of keto acids and the corresponding amino acids indicates that keto acids are transaminated very quickly. Due to the physiological pathways by which ketoacids are utilized in the body, it is likely that exogenous ketoacids are very quickly integrated into metabolic cycles. Keto acids go through the same catabolic pathways as classical amino acids. No special studies on the elimination of ketoacid have yet been carried out.
Instructions for use of Ketosteril
The medicine is taken orally during meals. The tablets must be swallowed whole, with a sufficient amount of liquid - this is how they are best absorbed and included in metabolic processes.
The dosage of the drug is prescribed according to the patient’s weight at the rate of 1 tablet per 5 kg per day. The daily dose is divided into 3-4 doses. The average daily dose for an adult is 12 – 24 tablets.
The instructions for Ketosteril suggest carrying out a course of treatment throughout the entire period of decrease in glomerular filtration below 25 ml/min. At the same time, a diet with a reduced amount of protein is prescribed. When taking Ketosteril for a long time, you should periodically check the calcium level in your blood.
special instructions
It is necessary to regularly monitor the level of calcium in the blood plasma.
Ketosteril should be taken with food for better absorption and conversion into the corresponding amino acids. Sufficient caloric content of food should be ensured, about 30–40 kcal/kg/day.
For hereditary phenylketonuria, it should be taken into account that the drug contains phenylalanine.
Based on the degree of reduction of uremic symptoms under the influence of the drug Ketosteril, the dose of simultaneously prescribed aluminum hydroxide should be reduced accordingly. It is necessary to monitor the decrease in plasma phosphate levels.
Use during pregnancy and lactation. There is insufficient experience with the use of the drug Ketosteril during pregnancy and lactation. Reproductive toxicity studies do not indicate direct or indirect adverse effects on pregnancy, fetal development, childbirth or the puerperium. Use with caution during pregnancy.
The ability to influence reaction speed when driving vehicles or other mechanisms. Does not affect.
Interaction of Ketosteril with other drugs
Ketosteril cannot be used simultaneously:
- with calcium supplements – this can lead to hypercalcemia;
- with drugs that form sparingly soluble compounds with calcium - antibiotics tetracycline group , antibacterial drugs of the quinolone , drugs that contain iron, estramustine and fluorine ; There should be a gap of at least two hours between taking the listed drugs and Ketosteril.
If your condition improves while taking Ketosteril, in order to avoid disturbing the acid-base balance, you should gradually reduce the dose of aluminum hydroxide, which was prescribed for acidosis (a shift in the acid-base balance of the body towards increasing acidity).
Side effects
The frequency of side effects is estimated as follows: very often (≥1/10), often (1/100, 1/10), infrequently (1/1000, 1/100), rarely (1/10,000, 1/1000), very rare (1/10,000).
Metabolic disorders: very rarely - 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.
Persons with hypersensitivity may develop allergic reactions.
Reviews about Ketosteril
Kesteril is a drug that is used as part of a complex treatment for patients with renal impairment. Almost all patients who received it noted a gradual improvement in their general condition, confirmed by laboratory tests.
negative reviews about Ketosteril, but some patients noted that the improvement was too slow, which was most likely due to the severity of the disease.
Selling Ketosteril for cats
Recently, Ketosteril has increasingly been used to treat cats with impaired renal function. Many speak very highly of this drug - it can significantly alleviate the condition of pets. And since cats require significantly fewer tablets than people, owners often try to sell the remaining tablets. But is it worth buying medicines second-hand, since there are so many counterfeits today?
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Note!
Description of the drug Ketosteril table. p/o No. 100 on this page is a simplified author’s version of the apteka911 website, created on the basis of the instructions for use.
Before purchasing or using the drug, you should consult your doctor and read the manufacturer's original instructions (attached to each package of the drug). Information about the drug is provided for informational purposes only and should not be used as a guide to self-medication. Only a doctor can decide to prescribe the drug, as well as determine the dose and methods of its use.
