Nephrotor

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 USP 105 mg, L-threonine USP 53 mg, L-histidine free base USP 38 mg, L-tyrosine USP 30 mg, L-tryptophan USP 23 mg.
Total nitrogen content per tablet: 36 mg.
Calcium content per tablet: 1.25 mmol=50 mg.

Renal nutrition therapy.
Pharmacology: Pharmacodynamics: Nephrotor allows the intake of essential amino acids while minimizing the amino-nitrogen intake. Following absorption, the keto and hydroxy-analogies are transaminated to the corresponding essential amino acids by taking nitrogen from non-essential amino acids, thereby 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 hyperphosphataemia and secondary hyperparathyroidism. Moreover, renal osteodystrophy may be improved.
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 the plasma level of ketoanalogues, 10 minutes after an 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 ketoanalogue 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) i.e., generally in patients with a glomerular filtration rate (GFR) between 5 and about 15 mL/minutes.

For oral use.
Adults (70 kg body weight): If not otherwise prescribed, take 4 to 8 tablets three times a day during meals. Swallow whole. Do not chew or crush.
Duration of Application: Nephrotor 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).

Allergy and hypersensitivity to any content of this drug; hypercalcemia; disturbed amino acid metabolism; caution use for patients with phenylketonuria.

Ketoanalogues + Essential amino acids contain phenylalanine, it should be used with caution in phenylketonuric patients.

In the presence of hereditary phenylketonuria, attention should be given to the fact that Nephrotor contains phenylalanine.

No experience has been made so far with the administration of Ketoanalogues + Essential amino acids as well as any source of calcium.

Hypercalcemia may develop. In this case, it is recommended to decrease Vitamin D intake. If hypercalcemia persists, reduce the dosage of Nephrotor 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 pediatric patients. Hypercalcemia may develop. In this case, it is recommended to decrease Vitamin D intake. If hypercalcemia persists, reduce the dosage of Nephrotor as well as other source of calcium.

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

Store at temperatures not exceeding 30°C. Protect from light.

Other Drugs Acting on the Genito-Urinary System

A16AA - Amino acids and derivatives ; Used in treatment of alimentary tract and metabolism problems.

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