Each tablet contains calcium-3-methyl-2-oxovalerate (α-ketoanalogue to isoleucine, calcium salt) 67 mg, calcium-4-methyl-2-oxovalerate (α-ketoanalogue to leucine, calcium salt) 101 mg, calcium-2-oxo-3-phenylpropionic acid (α-ketoanalogue to phenylalanine, calcium salt) 68 mg, calcium-3-methyl-2-oxobutyrate (α-ketoanalogue to valine, calcium salt) 86 mg, calcium-DL-2-hydroxy-4-(methylthio)-butyrate (α-hydroxyanalogue to methionine, calcium salt) 59 mg, L-lysine acetate 105 mg equivalent to L-lysine 75 mg, L-threonine 53 mg, L-tryptophan 23 mg, L-histidine 38 mg, L-tyrosine 30 mg.
Total nitrogen content/tablet: 36 mg.
Calcium content/tablet: 1.25 mmol=50 mg.
Pharmacology: Pharmacodynamics: Ketosteril allows the intake of essential amino acids while minimising the amino-nitrogen intake.
Following absorption, the keto- and hydroxy-analogues are transaminated to the corresponding essential amino acids by taking nitrogen from non-essential amino acids, therby decreasing the formation of urea by re-using the amino group. Hence, the accumulation of uraemic toxins is reduced. Keto and hydroxy acids do not induce hyperfiltration of the residual nephrons. Ketoacid containing supplements exert positive effect on renal hyper phosphataemia and secondary hyperparathyroidism. Moreover, renal osteodystrophy may be improved. The use of Ketosteril in combination with a very low protein diet allows to reduce nitrogen intake while preventing the deleterious consequences of inadequate dietary protein intake and malnutrition.
Pharmacokinetics: The plasma kinetics of amino acids and their integration in the metabolic pathways are well established. It should nevertheless be noted that in uraemic patients, the cause of the changed plasma levels, which occur frequently in these patients, does not seem to be the absorption of the supplied amino acids, i.e. the absorption itself is not disturbed. The changed plasma levels seem to be due to impaired post-absorptive kinetics, which can be detected in a very early stage of a disease.
In healthy individuals, the plasma levels of ketoacids increase within 10 min after oral administration. Increases of up to the 5-fold the baseline levels are achieved. Peak levels occur within 20-60 min, and after 90 min levels stabilise in the range of the base levels. Gastrointestinal absorption is thus very rapid. The simultaneous increases in the levels of the ketoacids and the corresponding amino acids show that the ketoacids are transaminated very rapidly. Due to the physiological utilisation pathways of ketoacids in the body it is likely that exogenously supplied ketoacids are very rapidly integrated into the metabolic cycles. Ketoacids follow the same catabolic pathways as classical amino acids. No specific study on ketoacid excretion has been performed to date.
Prevention and therapy of damages due to faulty or deficient protein metabolism in chronic renal insufficiency in connection with limited protein in food of 40 g/day (for adults) ie, generally in patients with a glomerular filtration rate (GFR) between 5 and about 15 ml/minutes.
For oral use.
Adults (70 kg body weight): If not otherwise prescribed, take 4 to 8 tablets three times a day during meals. Swallow whole.
Duration of Application: Ketosteril tablets are given as long as the glomerular filtration rate (GFR) is between 5 and about 15 mL/minute. Simultaneously food should contain 40 g/day protein or less (adults).
Ketosteril tablets are administered for nutrition therapy in chronic kidney disease.
Hypersensitivity to the active substances or to any of the excipients. Hypercalcaemia. Disturbed amino acid metabolism.
In the presence of hereditary phenylketonuria, attention should be given to the fact that Ketosteril contains phenylalanine.
There are no adequate data from the use of Ketosteril in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Caution should be exercised when prescribing to pregnant women.
No experience has been made so far with the use during lactation.
No case of overdose has been reported.
Hypercalcemia may develop. In this case it is recommended to decrease Vitamin D intake. If hypercalcaemia persists, reduce the dosage of Ketosteril as well as other source of calcium.
The serum calcium level should be monitored regularly.
Ensure sufficient calorie intake.
No experience has been gained so far with the administration in paediatric patients.
Concomitant administration of calcium-containing drugs may cause or aggravate elevated serum calcium levels.
Uraemic symptoms improve under therapy with Ketosteril. Thus, in case of aluminium hydroxide administration, the dose of this drug has to be reduced if necessary. Serum phosphate levels should be monitored for a decrease. Drugs that form sparingly soluble compounds with calcium (e.g. tetracyclines, quinolones such as ciprofloxacin and norfloxacin as well as drugs containing iron, fluoride or estramustine) should not be taken at the same time with Ketosteril to avoid disturbed absorption of the active substance. An interval of at least two hours should elapse between the ingestion of Ketosteril and these drugs.
The susceptibility to cardioactive glycosides, and hence the risk for arrhythmia will increase in Ketosteril produces elevated serum calcium levels).
Monitoring of the serum phosphate levels is needed in case of concomitant administration of aluminium hydroxide.
Do not store above 30°C.
Shelf-Life: 3 years.
A16AA - Amino acids and derivatives ; Used in treatment of alimentary tract and metabolism problems.
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