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Indications/Uses
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.
Dosage/Direction for Use
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.
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.
Overdosage
No symptoms have been observed to date.
Administration
Should be taken with food.
Contraindications
Hypercalcemia, disturbed amino acid metabolism. In case of hereditary phenylketonuria, it has to be taken into account that Ketobest contains phenylalanine.
Warnings
Ketobest contains phenylalanine, it should be used with caution in phenylketonuric patients.
Special Precautions
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.
Use in Pregnancy & Lactation: No experience has been made so far with the administration of Ketobest during pregnancy and lactation.
Use In Pregnancy & Lactation
No experience has been made so far with the administration of Ketobest during pregnancy and lactation.
Adverse Reactions
Hypercalcemia may develop.
Drug Interactions
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.
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.
Storage
Store at temperatures not exceeding 25°C.
Action
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.
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.
MedsGo Class
Other Drugs Acting on the Genito-Urinary System
Features
Brand
Ketobest
Full Details
Dosage Strength
600mg
Drug Ingredients
- Amino Acid
- Ketoanalogues
Drug Packaging
Film-Coated Tablet 1's
Generic Name
Ketoanalogues / Essential Amino Acids
Dosage Form
Film-Coated Tablet
Registration Number
DRP-3558
Drug Classification
Prescription Drug (RX)