Ketosteril Tablet

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) 25 mL/minutes.

Each film-coated tablet contains:

• (RS)-3-methyl-2-oxovaleric acid (α-ketoanalogue to DL-isoleucine), calcium-salt: 67 mg
• 4-methyl-2-oxovaleric acid (α-ketoanalogue to leucine), calcium-salt: 101 mg
• 2-oxo-3-phenylpropionic acid (α-ketoanalogue to phenylalanine), calcium-salt: 68 mg
• 3-methyl-2-oxobutyric acid (α-ketoanalogue to valine), calcium salt: 86 mg
• (RS)-2-hydroxy-4-methylthio-butyric acid (α-hydroxyanalogue to DL-methionine), calcium-salt: 59 mg
• L-lysine acetate corresponding to 75 mg
• L-lysine: 105 mg
• L-threonine: 53 mg
• L-tryptophan: 23 mg
• L-histidine: 38 mg
• L-tyrosine: 30 mg
• Total nitrogen content per tablet: 36 mg
• Calcium content per tablet: 50 mg.

This tablet 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 this tablet 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.

Adults (70 kg body weight): If not otherwise prescribed, take 4 to 8 tablets three times a day during meals. Swallow whole and must not be chewed. Ingestion during meals facilitates proper absorption and the metabolisation into the corresponding amino acids.

Duration of Application: This 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).

• Concomitant administration of calcium-containing drugs may cause or aggravate elevated serum calcium levels.
• Drugs that form hardly soluble compounds with calcium (e.g. tetracyclines, quinolines such as ciprofloxacin and norfloxacin as well as drugs containing iron, fluoride or estramustine) should not be taken at the same time with this tablet to avoid disturbed absorption of the active substances. An interval of at least two hours should elapse between the ingestion of this tablet and these drugs.
• The susceptibility to cardioactive glycosides, and hence the risk for arrhythmia will increase if this tablet produces elevated serum calcium levels.
• Uraemic symptoms improve under therapy with this tablet. Thus, in case of aluminium hydroxide administration, the dose of Ketosteril has to be reduced if necessary. Serum phosphate levels should be monitored for a decrease.

Hypersensitivity to the active substances or to any of the excipients. Hypercalcaemia. Disturbed amino acid metabolism.

Hypercalcemia may develop. In this case it is recommended to decrease Vitamin D intake. If hypercalcaemia persists, reduce the dosage of this tablet 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.

There are no adequate data from the use of this tablet 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.

• The serum calcium level should be monitored regularly.
• Ensure sufficient calorie intake.
• In the presence of hereditary phenylketonuria, attention should be given to the fact that this tablet contains phenylalanine.
• Monitoring of the serum phosphate levels is needed in case of concomitant administration of aluminium hydroxide.

Drugs used in chronic kidney dialysis

Do not store above 30° C. Store in the original package and keep the blisters tightly closed to protect contents from moisture.