Ketosteril®

Alpha Ketoanalogues of essential amino acids tablets

  • ​Ketosteril® is part of the conservative treatment of patients with Chronic Kidney Disease. Ketosteril® contains amino acids, partly in form of there corresponding-ketoanalogues, essential for patients with Chronic Kidney Disease. In combination with a protein-restricted diet Ketosteril® is an excellent tool to treat Chronic Kidney Disease in the predialysis period.
 

The signs/names marked with ® are registered trademarks of the Fresenius Group in selected countries.

  • Prevention & therapy of damages due to CKD till GFR is 15 ml/min,i.e.stages II, III & IV of CKD

  • Presentation:
    Pack containing 100 film-coated tablets in blister
  • Dosage / Administration: For Oral Use.
  • If  not otherwise prescribed, take 4-8 tablets three times a day during meals. Swallow whole. This dosage applies to adults (70kg/BW)

  • Reduction of uraemic symptoms, which are largely due to an accumulation of degradation products of the protein metabolism
  • Preservation of the residual renal function and therefore slowing down the rate of progression of the chronic kidney disease and delaying the onset of dialysis
  • Preservation of the nutritional status, despite the marked reduction of the daily protein intake
  • Improvement of metabolic complications due to renal insufficiency (e.g. proteinuria, disturbances in calcium-phosphate, carbohydrate and lipid metabolism)

One film-coated tablet contains:

  • Calcium 3-methyl-2-oxovaleric acid (a-ketoanalogue of isoleucine, Ca-salt) 67 mg
  • Calcium-methyl-2-oxovaleric acid (a-ketoanalogue of leucine, Ca-salt) 101 mg
  • Calcium-2-oxo-3-phenylpropionic acid (a-ketoanalogue of phenylalanine, Ca-salt) 86 mg
  • Calcium-3-methyl-2-oxobutyric acid (a-ketoanalogue of valine, Ca-salt) 68 mg
  • Calcium-DL-2-hydroxy-4-(methylthio)-butyric acid (a-hydroxyanalogue ofmethionine) 59mg, Ca-salt 105 mg
  • L-lysine acetate (= L-lysine 75 mg) 53 mg
  • L-threonine 23 mg
  • L-tryptophan 38 mg
  • L-histidine 30 mg
  • L-tyrosine

Total nitrogen content per tablet: 36 mg
Calcium content per tablet: 1.25 mmol = 0.05 g

Other ingredients

Corn starch, crospovidone, povidone (K-value 29-32), talc, highly dispersed silicon dioxide, magnesium stearate, macrogol 6000, colouring agents E 104, E 171, alkaline polymethacrylate, glycerol triacetate.

Indications

Prevention & therapy of damages due to CKD till GFR is 15 ml/min,i.e.stages II, III & IV of CKD

Contra-indications

Hypercalcaemia, disturbed amino acid metabolism. In case of hereditary phenylketonurie it has to be taken into account that this product contains phenylalanine.

Precautions for use and warnings

No experience has been made so far with the application in pregnancy and paediatrics.
Ketosteril® should be taken during meals to allow proper absorption and metabolism into the corresponding amino acids. The serum calcium level should be monitored regularly. An adequate supply of calories should be ensured.

Undesirable effects

Hypercalcaemia may develop. In this case, it is recommended to decrease vitamin D intake. If the hypercalcaemia persists, reduce the dosage of Ketosteril® as well as any other source of calcium.

Dosage instructions

In general, unless prescribed otherwise, take four to eight tablets three times a day during meals. This dosage applies to adults (70 kg bodyweight)

Instructions for use/handling/storage

Do not use Ketosteril® after expiry date! Keep out of the reach of children! Do not store above 25°C. Protect from moisture.

Interaction with other drugs

Simultaneous administration of medicinal products that contain calcium (e.g. acetolyte) may trigger, or worsen, a pathological increase in the serum calcium level.

As the uraemic symptoms improve under therapy with Ketosteril® tablets, the dose of aluminium hydroxide administered should be reduced, as appropriate. The patient should be monitored for reduced levels of serum phosphate.
In order not to interfere with absorption, an appropriate interval should be observed between administration of Ketosteril® tablets and medicinal products which form poorly soluble compounds with calcium (e.g. tetracyclines, quinolones such as ciprofloxacin and norfloxacin, preparations that contain iron, fluoride and estramustin). An interval of at least 2 hours should be observed between the intake of Ketosteril® tablets and such preparations. If administration of Ketosteril® tablets leads to increased blood levels of calcium, the sensitivity to medicinal products which increase heart action (cardiac glycosides) and thus also the risk of cardiac arrhythmia is increased.


The signs/names marked with ® are registered trademarks of the Fresenius Group in selected countries.

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  • ​Please note that these products may not be available in all countries due to different registration status. Additionally, approved indications, contraindications, side effects, warnings and all over product characteristics may differ between countries. Therefore, always the text of the nationally registered and approved product information is binding!
  • Furthermore, country specific regulatory considerations affect the information we can provide on our products.
  • If you require any information please contact your local organization.