Ketosteril®

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 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 per day (for adults) and less; i.e. generally in patients with a glomerular filtration rate (GFR) below 25 ml/min.

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, four to eight tablets are swallowed whole three times daily during meals. This dosage applies to adults (70 kg bodyweight) (1 tablet/5 kg body weight/day).

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.

​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 per day (for adults) and less; i.e. generally in patients with a glomerular filtration rate (GFR) below 25 ml/min.

• Presentation:
  Pack containing 100 film-coated tablets in blister
• Dosage / Administration: 
  Please refer to the nationally registered and approved product information

​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.

• 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 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)

​Fresenius Kabi offers to medical professionals and to patients educational tools.

• Aparacio M., Chauveau P., de Prècigout V., Bouchet J.L., Lasseur C., Combe C.
  Nutrition and outcome on renal replacement therapy of patients with chronic renal failure treated by a supplemented very low protein diet
  J. Am. Soc. Nephrol. 2000; 12: 708-716
• Barsotti G., Cupisti A., Barsotti M., Sposini S., Palmieri D., Meola M., Lenti C., Morelli E.
  Dietary treatment of diabetic nephropathy with chronic renal failure
  Nephrol. Dial. Transplant 1998; 13 (Suppl. 8): 49-52
• Barsotti G., Cupisti A., Morelli E., Meola M., Cozza V., Barsotti M., Giovanetti S.
  Secondary hyperparathyroidism in severe chronic renal failure is corrected by very-low dietary phosphate intake and calcium supplementation and calcium carbonate supplementation
  Nephron. 1998; 79: 137-141
• Bernhard J., Beaufrere B., Laville M., Fougue D.
  Adaptive response to a low-protein diet in predialysis chronic renal failure patients.
  J. Am. Soc. Nephrol. 2001; 12: 1249-1254
• Combe C., Aparicio M.
  Phosphorus and protein restriction and parathyroid function in chronic renal failure.
  Kidney Int. 1994; 46: 1381-1386
• Coresh J., Walser M., Hill S.
  Survival on dialysis among chronic renal failure patients treated with a supplemented low-protein diet before dialysis
  J. Am. Soc. Nephrol. 1995; 6: 1379-1385
• Cupisti A., Licita R., Chisari C., Stampacchia G., D'Alessandro C., Galetta F., Rossi B., Barsotti G.
  Skeletal muscle and nutritional assessment in chronic renal failure patients on a protein-restricted diet.
  J. Int. Med. 2004; 255: 115-124
• Di Iorio B.R., Minutolo R., De Bicola L., Bellizzi V., Catalano F., Iodice C., Rubino R.,
  Cont G.
  Supplemented very low protein diet ameliorates responsiveness to erythropoietin in chronic renal failure.
  Kidney Int. 2003; 64: 1822-182
• Feiten S.F., Draibe S.A., Watanabe R., Duenhas M.R., Baxmann A.C., Nerbass F.B., Cuppari L.
  Short-term effects of a very low protein diet supplemented with ketoacids in non-dialyzed chronic kidney patients
  Eur. J. Clin. Nutr. 2005 ; 59:129-136
• Fouque D., Wang P., Laville M., Boissel J.P.
  Low protein diets for chronic renal failure in non diabetic adults.
  The Cochrane Library 2003, Volume 1
• ​Gin H., Aparicio M., Potaux L., Merville P., Combe C., de Precigout V., Bouchet J.L., Aubertin J.
  Low-protein, low-phosphorus diet and tissue insulin sensitivity in insulin dependent diabetic patients with chronic renal failure.
  Nephron. 1991; 57: 411-415
• Hansen H.P.; Tauber-Lassen E., Jensen B.R.; Parving H.H
  Effect of dietary protein restriction on prognosis in patients with diabetic nephropathy
  Kidney Int. 2002; 62: 220-228
• Lafage M.H., Combe C., Fournier A., Aparicio M.
  Ketodiet, physiological calcium intake and native vitamin D improve renal osteodystrophy
  Kidney Int. 1992; 42: 1217-1225
• Masud T., Young V.R., Chapman T., Maroni B.
  Adaptive responses to very low protein diets: the first comparison of ketoacids to essential amino acids
  Kidney Int. 1994; 45: 1182-1192
• Mir S., Özkayin N., Akgun A.
  The role of keto acids in the supportive treatment of children with chronic renal failure
  Pediatr. Nephrol. 2005; 20: 950-955
• Mitch W.E.
  Beneficial responses to modified diets in treating patiens with chronic kidney disease
  Kidney Int. 2005; 67 S94: 133-135
• Pedrini M.T., Levey A.S., Lau J.L., Chalmers T.C., Wang P.H.
  The effect of dietary protein restriction on the progression of diabetic and nondiabetic renal diseases: a meta analysis
  Ann. Intern. Med. 1996; 124: 627-632
• Prakash S., Pande D.P., Sharma S., Sharma D., Bal C.S., Kulkarni H.
  Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate Efficacy of Ketodiet in Predialytic Chronic Renal Failure.
  J. Renal Nutr. 2004; 14: 89-96
• Rigalleau V., Blanchetier V., Combe C., Guillot C., Deleris G., Aubertin J., Aparicio M., Gin H.
  A low-protein diet improves insulin sensitivity of endogenous glucose production predialytic uremic patients.
  Am. J. Clin. Nutr. 1997; 65: 1512-1516
• Teplan B., Schuck O., Horauova M., Skibova J.
  Effect of a keto acid – amino acid supplement on the metabolism an renal elimination of branched-chain amino acids in patients with chronic renal insufficiency on low protein diet
  Wien. Klin. Wochenschr. 2000;112: 876-881
• Teplan V., Schuck O., Knotek A., Hajny J., Horackova M., Kvapil M.
  Enhanced metabolic effect of erythropoietin and keto acids in CRF patients on low-protein diet: Czech multicenter study.
  Am. J. Kidney Dis. 2003, 41 (Suppl 1): 26-30
• Teplan V., Schuck O., Knotek A., Hajny J., Horackova M., Skibova J., Maly J.
  Effects of low-protein diet supplemented with ketoacids and erythropoietin in chronic renal failure: a long-term metabolic study.
  Annals of Transplantation 2001; 6: 47-53
• Teschan P.E., Beck G.J., Dwyer J.T., Greene T., Klahr S., Levey A.S., Mitch W.E., Snetselaar L.G., Steinman T.O., Walser M.
  Effect of a ketoacid-aminoacid-supplemented very low protein diet on the progression of advanced renal disease: a reanalysis of the MDRD feasibility study
  Clin. Nephrol. 1998; 50: 273-283
• Tom K., Young V.R., Chapman T., Masud T., Akpele L., Maroni B.J.
  Long-term adaptive responses to dietary protein restriction in chronic renal failure.
  Am. J. Physiol. 1995; 4: 668-677
• Vendrely B., Chauveau P., Barthe N., El Haggan W., Cataing F., de Precigout V.,
  Combe C., Aparicio M.
  Nutrition in hemodialysis patients previously on a supplemented very low protein diet.
  Kidney Int. 2003; 63: 1491-1498
• Walser M., Hill S.
  Can renal replacement be deferred by a supplemented very low protein diet?
  J. Am. Soc. Nephrol. 1999; 10: 110-116
• Walser M., Mitch W.E., Maroni B.J., Kopple J.D.
  Should protein intake be restricted in predialysis patients
  Kidney Int. 1999; 55: 771-777
• Zakar G. for the study group
  The effect of keto acid supplement on the course of chronic renal failure and nutritional parameters in predialysis patients and patients on regular hemodialysis therapy.
  Wien. Klin. Wochenschr. 2001; 113: 688-694