Ketolog^®

Ketolog 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 reusing the amino group. The levels of accumulating uremic toxins are decreased. Keto-acids and/or hydroxy-acids do not elicit hyperfiltration of residual nephrons. Ketoacid containing supplements have a positive influence on the renal hyper-phosphatemia and secondary hyper- parathyroidism and can improve renal osteodystrophy. The use of Ketolog 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.

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Ketolog is indicated for 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.

Route of administration: Ketolog should be taken in oral route during meals. The tablets must not be chewed. Ingestion during meals facilitates proper absorption and the metabolisation into the corresponding amino acids.

Adult dose (70 kg body weight) is 4 to 8 tablets three times daily during meals.

Pregnancy: There are no adequate data from the use of amino acid keto analogues in pregnant women. Caution should be exercised when prescribing to pregnant women.
Lactation: No experience has been made so far with the use during lactation.

Use in children and adolescent
Safety and effectiveness of pediatric patient have not been established.

The serum calcium level should be monitored regularly. Ensure sufficient calorie intake. If hypercalcemia occurs, the intake of vitamin D should be reduced. In case of persisting hypercalcemia, the dose of amino acid keto analogues as well as the intake of any other calcium sources has to be reduced. In the presence of hereditary phenylketonuria, attention should be given to the fact that amino acid keto analogues contains phenylalanine. Monitoring of the serum phosphate levels is needed in case of concomitant administration of aluminium hydroxide.

The most common side effect is hypercalcemia.

It is contraindicated in patients with history of known hypersensitivity to amino acid keto analogues or any other components of this product. It is also contraindicated in patients with hypercalcemia, disturbed amino acid metabolism.

Drug interaction with medication: 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 amino acid keto analogues to avoid disturbed absorption of the active substances. An interval of at least two hours should elapse between the ingestion of amino acid keto analogues and these drugs.

Drug interaction with food and others: Not applicable

No data is available in regard to overdosage in human.

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Ketolog 600 mg Tablet: Each coated tablet contains (a- Ketoanalogue to lsoleucine, Calcium salt) 67 mg, (a- Ketoanalogue to Leucine, Calcium salt) 101 mg, (a- Ketoanalogue to Phenylalanine, Calcium salt) 68 mg, (a- Ketoanalogue to Valine, Calcium salt) 86 mg, (a­Hydroxyanalogue to Methionine, Calcium salt) 59 mg, L- Lysine Acetate USP 105 mg (eqv. to L-Lysine 75 mg), L- Threonine USP 53 mg, L- Tryptophan USP 23 mg, Histidine Hydrochloride Monohydrate BP eqv. to Histidine 38 mg and L- Tyrosine USP 30 mg.

Total nitrogen per tablet: 36 mg

Calcium content per tablet: 50 mg

Storage
Keep away from the reach of children. Store below 30°C in a dry place, protected from light. To be taken and sold only on the prescription of a registered physician.

Packing
Ketolog® 600 mg Tablet: Carton of 60 tablets in blister pack.