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.
Total nitrogen content per tablet: 36 mg. Calcium content per tablet: 1.25 mmol = 50 mg.
Ketoanalogues + Essential amino acids tablet (Nefrotein) contains all amino acids essential for uremic patients, five of them are keto or hydroxyanalogues in the form of calcium salts. Therefore, it allows reduction in the nitrogen supply and provides calcium. It is a medication for the treatment of chronic kidney disease patients on conservative management therapy (CKD stage I, II, III). In combination with very low protein diet, it helps in delaying the progression of kidney disease in the predialysis period.
Pharmacology: Therapeutic Action: Normalizes metabolic process, promotes recycling product exchange. Reduces ion concentration of potassium, magnesium and phosphate.
Pharmacokinetics: In normal individuals, there is an increase in plasma level of ketoanalogues, 10 minutes 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.
For 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 per day (for adults) and less; i.e. generally in patients with a glomerular filtration rate (GFR) below 25 mL/min.
For oral use.
Four to eight tablets, three times a day.
1 tablet/5 kg body weight per day.
Should be taken with food (Swallow whole, do not chew/crush).
Allergy and hypersensitivity to any content of this drug.
Hypercalcemia.
Disturbed amino acid metabolism.
Caution use for patients with phenylketonuria.
Ketoanalogues + Essential amino acids (Nefrotein) contains phenylalanine, it should be used with caution in phenylketonuric patients.
Ketoanalogues + Essential amino acids (Nefrotein) 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 (Nefrotein) during pregnancy and lactation.
Hypercalcemia may develop in this case, it is recommended to decrease vitamin D intake.
If the hypercalcemia persists, reduce the dosage of Ketoanalogues + Essential amino acids (Nefrotein) as well as any source of calcium.
The simultaneous administration of medicaments containing calcium (e.g. acetolyte) may lead to pathological increases of the serum calcium level or intensification.
As the uraemic symptoms improve under Ketoanalogues + Essential amino acids (Nefrotein), 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 Ketoanalogues + Essential amino acids (Nefrotein) that form sparingly soluble compounds with calcium (e.g. tetracyclines, quinolone e.g. ciprofloxacin and norfloxacin, iron-, fluoride- and estramustin-containing drugs). Between the intake of Ketoanalogues + Essential amino acids (Nefrotein) 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 rise of blood calcium concentration.
Store at temperatures not exceeding 30°C. Protect from light.
V06DE - Amino acids/carbohydrates/minerals/vitamins, combinations ; Used as general nutrients.
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