Ketocid

Ketoanalogues, 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-ketoanalogue 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.

Pharmacology: Pharmacokinetics: The plasma kinetics of 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.
In healthy individuals, the plasma levels of ketoacids increase within 10 min after oral administration. Increases of up to the 5-fold the baseline levels are achieved. Peak levels occur within 20-60 min, and after 90 min levels stabilise in the range of the base levels. Gastrointestinal absorption is thus very rapid. The simultaneous increases in the levels of the ketoacids and the corresponding amino acids show that the ketoacids are transaminated very rapidly. Due to the physiological utilisation pathways of ketoacids in the body it is likely that exogenously supplied ketoacids are very rapidly integrated into the metabolic cycles. Ketoacids follow the same catabolic pathways as classical amino acids. No specific study on ketoacid excretion has been performed to date.

Prevention and treatment of damages due to faulty or deficient protein metabolism in chronic kidney disease in connection with a limited dietary protein intake of 40 g/day or less (adult). Usually this applies to patients whose glomerular filtration rate (GFR) is less than 25 mL/min.

For adults (70 kg body weight) 3 times a day, 4 to 8 tablets every time during meals. For patients with glomerular filtration rate lower than for 25mL/min, this product can be used long time with no more than 40 grams daily (adult) of low protein diet.

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

The serum calcium level should be monitored regularly.
Ensure sufficient calorie intake.
No experience has been gained so far with the administration in paediatric patients. In the presence of hereditary phenylketonuria, attention should be given to the fact that Ketonol contains phenylalanine.
Monitoring of the serum phosphate levels is needed in case of concomitant administration of aluminium hydroxide.

There are no adequate data from the use of Ketonol in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development.
Caution should be exercised when prescribing to pregnant women.
No experience has been made so far with the use during lactation.

May cause hypercalcemia, therefore monitor the serum calcium level periodically. In this case recommended to decrease vitamin D intake. If the hypercalcemia persists, reduce the dosage of Ketocid as well as any source of calcium.

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, quinolines such as ciprofloxacin and norfloxacin as well as drugs containing iron, fluoride or estramustine) should not be taken at the same time with Ketonol to avoid disturbed absorption of the active substances. An interval of at least two hours should elapse between the ingestion of Ketonol and these drugs.
The susceptibility to cardioactive glycosides, and hence the risk for arrhythmia will increase if Ketonol produces elevated serum calcium levels.
Uraemic symptoms improve under therapy with Ketonol. Thus, in case of aluminium hydroxide administration, the dose of this drug has to be reduced if necessary. Serum phosphate levels should be monitored for a decrease.

Store at temperature 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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