Ketoanalogues, essential amino acids.
Each film-coated tablet contains: Calcium-4-methyl-2-oxo-valerate (α-ketoanalogue to leucine, calcium salt) 101 mg, Calcium-3-methyl-2-oxo-butyrate (α-ketoanalogue to valine, calcium salt) 86 mg, Calcium-2-oxo-3-phenylpropionate (α-ketoanalogue to phenylalanine, calcium salt) 68 mg, Calcium-3-methyl-2-oxo-valerate (α-ketoanalogue to isoleucine, calcium salt) 67 mg, Calcium-DL-2-hydroxy-4-(methylthio) butyrate (α-hydroxyanalogue to methionine, calcium salt) 59 mg, L-Lysine Acetate 105 mg, L-Threonine 53 mg, L-Histidine 38 mg, L-Tyrosine 30 mg, L-Tryptophan 23 mg.
Pharmacology: Ketoanalogues + Essential Amino Acids allows the intake of essential amino acids while minimizing the amino-nitrogen intake. Following ingestion, the ketoanalogues are transaminated by taking nitrogen from non-essential amino acids, thereby decreasing the formation of urea by re-using the amino group. The levels of accumulating uremic toxins are decreased. Keto- and/or hydroxy-acids do not elicit hyperfiltration of positive influence on the renal hyperphosphatemia and secondary hyperparathyroidism and can improve renal osteodystrophy. The use of Ketoanalogues + Essential Amino Acids in association with a very low protein diet allows a reduced intake of nitrogen while avoiding the deleterious consequences of inadequate dietary protein intake and malnourishment.
Pharmacokinetics: In normal individuals, there is an increase in the plasma level of ketoanalogues, 10 min after oral ingestion. These levels reach values that are approximately 5 times higher than the initial level. Peak levels are reached within 20-60 min, and normal levels are reached again after 90 min. Gastrointestinal absorption is thus very rapid. In the plasma, a simultaneous increase in levels of the ketoanalogue and the corresponding amino acid show that transamination of the ketoanalogues is very rapid. Due to the natural pathways of disposal of α-ketonic acids in the organism, it is probable that exogenous intakes are very rapidly integrated into metabolic cycles. Ketoacids follow the same catabolic pathways as the classical amino acids.
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/min.
4-8 tablets three times a day during meals. Swallow whole. Ketoanalogues + Essential Amino Acids is given as long as the GFR is <25 mL/min and a diet with an intake of maximum 40 g protein/day (for adults) is followed.
No symptoms have been observed to date.
Hypercalcemia, disturbed amino acid metabolism. In case of hereditary phenylketonuria, it has to be taken into account that Ketoanalogues + Essential Amino Acids contains phenylalanine.
Ketoanalogues + Essential Amino Acids contains phenylalanine, it should be used with caution in phenylketonuric patients.
Ketoanalogues + Essential Amino Acids should be taken during meals to allow proper absorption and metabolism into the corresponding amino acids. The serum calcium level should be monitored regularly. Ensure sufficient supply with calories.
No experience has been made so far with the administration of Ketoanalogues + Essential Amino Acids during pregnancy and lactation.
The simultaneous administration of medicaments containing calcium (eg, acetolyte) may lead to pathological increases of the serum calcium level or intensification.
As the uremic symptoms improve under Ketoanalogues + Essential Amino Acids, a possible administration of aluminum hydroxide should be reduced.
Pay attention to a reduction of serum phosphate.
In order not to interfere with absorption, do not take the drugs together with Ketoanalogues + Essential Amino Acids that form sparingly soluble compounds with calcium (e.g. tetracyclines, quinolones, eg, ciprofloxacin and norfloxacin, iron-, fluoride- and estramustin-containing drugs).
Between the intake of Ketoanalogues + Essential Amino Acids and drugs from the mentioned categories, a period of at least 2 hours should pass.
The susceptibility towards heart/cardiac-active glycosides and hence, also the risk of arrhythmia increases with the raise of the blood calcium concentration.
Store at temperatures not exceeding 30°C.
Protect from heat and sunlight exposure.
A16AA - Amino acids and derivatives ; Used in treatment of alimentary tract and metabolism problems.
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