Ketoanalogues, essential amino acids.
Each film-coated tablet contains DL-α-ketoisoleucine calcium 67 mg, α-ketoleucine calcium 101 mg, α-ketophenylalanine calcium 68 mg, α-ketovaline calcium 86 mg, DL-α-hydroxymethionine calcium 59 mg, L-lysine acetate 105 mg, L-threonine 53 mg, L-tryptophan 23 mg, L-histidine 38 mg, L-tyrosine 30 mg, total nitrogen 36 mg, total calcium 50 mg (equivalent to 125 mmol).
Pharmacology: Ketobest 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 residual nephrons. Ketoacid-containing supplements have a positive influence on the renal hyperphosphatemia and secondary hyperparathyroidism and can improve renal osteodystrophy. The use of Ketobest 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.
Toxicology: Toxicological studies indicate that Ketobest has a low toxicity. Chronic toxicity study showed that minimum toxic dose (MIT) was 1200 mg/day (dog) and 2700 mg/day (rat), respectively. The minimum toxic dose of human being (70 kg) after dose conversion was 84 g/day (according to dog) and 189 g/day (according to rat), respectively.
Ketobest was found to show no fetal toxicity.
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.
Adults (70 kg body weight): Unless otherwise prescribed, take 4-8 tablets three times a day during meals. Swallow whole.
Ketobest 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 Ketobest contains phenylalanine.
Ketobest contains phenylalanine, it should be used with caution in phenylketonuric patients.
Ketobest 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.
Use in Pregnancy & Lactation: No experience has been made so far with the administration of Ketobest during pregnancy and lactation.
No experience has been made so far with the administration of Ketobest during pregnancy and lactation.
Hypercalcemia may develop. In this case, it is recommended to decrease vitamin D intake. If hypercalcemia persists, reduce the dosage of Ketobest as well as any other source of calcium.
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 Ketobest, 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 drugs together with Ketobest that form sparingly soluble compounds with calcium (eg, tetracyclines, quinolones eg, ciprofloxacin and norfloxacin, iron-, fluoride- and estramustin-containing drugs).
Between the intake of Ketobest and drugs from the mentioned categories, a period of at least 2 hrs 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 25°C.
G04BX - Other urologicals ; Used in the treatment of urological problems.
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