Ketostal 600

Yellow coloured, capsule shaped both sides plain film-coated tablet.
Each film-coated tablet contains: Calcium-4-methyl-2-oxo-valerate 101 mg (α-ketoanalogue to leucine, calcium salt), Calcium-3-methyl-2-oxo-butyrate 86 mg (α-ketoanalogue to valine, calcium salt), Calcium-2-oxo-3-phenylpropionate 68 mg (α-ketoanalogue to phenylalanine, calcium salt), Calcium-3-methyl-2-oxo-valerate 67 mg (α-ketoanalogue to isoleucine, calcium salt), Calcium-DL-2-hydroxy-4-(methylthio) butyrate 59 mg (α-hydroxyanalogue to methionine, calcium salt), L-Lysine Acetate USP 105 mg, L-Threonine USP 53 mg, L-Histidine USP 38 mg, L-Tyrosine USP 30 mg, L-Tryptophan USP 23 mg, Total Nitrogen Content 36 mg, Calcium (1.25 mmol) = 0.05 g.
Colour: Quinoline Yellow & Titanium Dioxide.

Renal Nutrition Therapy.
Pharmacology: Pharmacodynamics: Ketoanalogues + Essential Amino Acids used for nutrition therapy in chronic kidney disease.
In absorption process, the keto- and hydroxy-analogues 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.
Ketoanalogues + Essential Amino Acids do not induce hyperfiltration of the residual nephrons. Ketoanalogues + Essential Amino Acids containing supplements exert a positive effect on renal hyperphosphataemia and secondary hyperparathyroidism. Moreover, renal osteodystrophy may be improved. The use of Ketoanalogues + Essential Amino Acids in combination with a very low protein diet allows to reduce nitrogen intake while preventing the deleterious consequences of inadequate dietary protein intake and malnutrition.
Pharmacokinetics: The plasma kinetics of essential amino acids and their integration in the metabolic pathways are well established. It should nevertheless be noted that in uraemic patients, the cause of the changed plasma levels, which occur frequently in these patients, does not seem to be the absorption of the supplied amino acids, i. e. the absorption itself is not disturbed. The changed plasma levels seem to be due to impaired post-absorptive kinetics, which can be detected in a very early stage of the disease.
Gastrointestinal absorption is thus very rapid. The simultaneous increase in the levels of the Ketoanalogues + Essential Amino Acids and the corresponding amino acids show that the Ketoanalogues + Essential Amino Acids are transaminated very rapidly. Due to the physiological utilization pathways of Ketoanalogues + Essential Amino Acids in the body, it is likely that exogenously supplied Ketoanalogues + Essential Amino Acids are very rapidly integrated into the metabolic cycles. Ketoacids follow the same catabolic pathways as classical amino acids. No specific study on Ketoanalogues + Essential Amino Acids excretion has been performed to date.

For prevention and therapy of damages due to faulty or deficient protein metabolism in chronic renal insufficiency in connection with limited protein food of 40 grams per day (for adults) and less. Usually, this applies to patients whose glomerular filtration rate (GFR) is less than 25 mL/min.

If not otherwise prescribed, the dose for adults (70 kg body weight) is 4 to 8 tablets three times daily during meals. The tablets must not chewed. Ingestion during meals facilities proper absorption and the metabolization into the corresponding amino acids. There is no experience in children.
For oral use.
Or as prescribed by the physician.
Duration of Administration: The product administered as long as the glomerular filtration rate (GFR) is below 25 mL/min, and concomitantly, dietary protein is restricted to 40 g/day or less (adult).

No specific information is available on the treatment of overdose with Ketoanalogues + Essential Amino Acids film-coated tablet.

Hypersensitivity to the active substances or to any of the excipients.
Hypercalcaemia.
Disturbed amino acid metabolism.

No experience has been made so far with the application in pregnancy and lactation.

Metabolism and nutrition disorders: Very rare: hypercalcaemia.
If hypercalcaemia occurs, the intake of vitamin D should be reduced. In case of persisting hypercalcaemia, the dose of the product as well as the intake of any other calcium sources has to be reduced.

Concomitant administration of calcium-containing drugs may cause or aggravate elevated serum calcium levels.
Drugs that form hardly 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 the products to avoid disturbed absorption of the active substances. An interval of at least two hours should elapse between the ingestion of the product and other drugs.
The susceptibility to cardioactive glycosides, and hence the risk for arrhythmia will increase if the product produces elevated serum calcium levels.
Uraemic symptoms improve under therapy with the product. Thus, in case of aluminum hydrochloride administration, the dose of these drugs has to be reduced if necessary. Serum phosphate levels should be monitored for a decrease.

Store at temperatures not exceeding 30°C.
Store in the original package and protect contents from moisture.
Consume immediately after opening the foil strip.

Other Drugs Acting on the Genito-Urinary System

G04BX - Other urologicals ; Used in the treatment of urological problems.

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