Instructions for Ketosteril film-coated tablets, blister pack No. 100
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 silica, magnesium stearate, polyethylene glycols (macrogols), quinoline yellow (E 104), acrylate copolymer, triacetin, titanium dioxide (E 171), povidone. | |
Dosage form
Film-coated tablets.
Main physicochemical 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. It improves nitrogen metabolism, promotes protein anabolism, reduces the severity of uremic symptoms, and improves the condition of patients with chronic kidney disease.
After absorption, ketoanalogues are transaminated into the corresponding essential L-amino acids by absorbing nitrogen from essential amino acids, thereby reducing urea formation by reusing the amino group, and promoting the disposal of nitrogen-containing metabolic products.
Ketosteril® in combination with a low-protein diet allows to reduce nitrogen intake, while preventing the harmful effects of insufficient dietary protein intake and malnutrition and provides the body with the necessary L-amino acids with minimal nitrogen intake. Ketone analogues of essential amino acids included in the preparation provide a full 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 on renal hyperphosphatemia and secondary hyperparathyroidism.
With the systematic use of Ketosteril, an improvement in the condition of patients with chronic renal failure has been noted. 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 uremic patients, the changes in plasma amino acid levels that are often observed are not due to the absorption of the supplied amino acids, i.e., absorption itself is not impaired. Altered plasma amino acid levels associated with impaired post-absorptive kinetics can be detected very early in the disease.
In healthy individuals, plasma levels of ketoacids increase within 10 minutes after oral administration. A maximum of 5-fold increase in basal levels is achieved. Peak levels are observed within 20-60 minutes, and after 90 minutes the levels stabilize in the basal range. Gastrointestinal absorption is therefore very rapid. The simultaneous increases in levels of ketoacids and the corresponding amino acids indicate that ketoacids are transaminated very rapidly. Due to the physiological pathways for the utilization of ketoacids in the body, it is likely that exogenous ketoacids are very rapidly integrated into metabolic cycles. Ketoacids follow the same catabolic pathways as classical amino acids. No specific studies on ketoacid excretion have been performed to date.
Indication
Prevention and treatment of disorders caused by altered or insufficient protein metabolism in chronic renal failure in combination with limited dietary protein intake of up to 40 g per day (for adults) or less. Use in patients with a glomerular filtration rate (GFR) less than 25 ml/min.
Contraindication
Hypersensitivity to the components of the drug. Hypercalcemia, amino acid metabolism disorders.
Interaction with other medicinal products and other types of interactions
Concomitant administration of calcium-containing drugs may lead to an increase in serum calcium levels.
Susceptibility to cardiac 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 administration of aluminum hydroxide. It is necessary to monitor the decrease in serum phosphate levels.
Application features
Serum calcium levels should be monitored regularly.
Ketosteril should be taken with food for better absorption and conversion into the corresponding amino acids. It is necessary to ensure sufficient caloric intake of about 30-40 kcal/kg/day.
In case of hereditary phenylketonuria, it should be taken into account that the drug contains phenylalanine.
According to 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 the decrease in serum phosphate levels.
Use during pregnancy or breastfeeding
There is insufficient experience with the use of Ketosteril during pregnancy and breastfeeding. 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 reaction speed when driving vehicles or other mechanisms
Does not affect.
Method of administration and doses
The drug is to be used orally. Unless otherwise prescribed, Ketosteril should be taken at the rate of 1 tablet per 5 kg of body weight/day (0.1 g/kg of body weight/day), or 4-8 tablets (the dose is calculated for a patient weighing 70 kg) 3 times a day with meals.
Swallow the tablets without chewing. Ketosteril should be prescribed simultaneously with a low-protein diet (protein restriction in the diet) of 40 g per day or less.
Children
There is no experience with use in children, so the drug is not recommended for use in this category of patients.
Overdose
There are no reports of overdose.
Adverse reactions
Adverse effect frequencies are estimated as follows: very common (≥ 1/10), common
(> 1/100, < 1/10), uncommon (> 1/1000, < 1/100), rare (> 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, the dose of Ketosteril should be reduced, as should other sources of calcium.
In people with hypersensitivity, allergic reactions may develop.
Expiration date
3 years.
Storage conditions
Store in the original packaging to protect from moisture at a temperature not exceeding 25 ºС.
Keep out of reach of children.
Packaging
20 tablets in a blister, 5 blisters (in a foil bag) in a cardboard pack.
Vacation category
According to the recipe.
Producer
Labesfal Laboratories Almiro, S.A.
Location of the manufacturer and its business address
Lagedo, Santiago de Besteiros, 3465-157, Portugal.
Applicant
Fresenius Kabi Deutschland GmbH.
Location of the applicant and/or applicant's representative
Else-Kröner-Strasse 1, 61352 Bad Homburg, Germany.
