KETOSTERIL TABLETS 100 FILM-COATED TABLETS

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

Features
​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 both healthy person and 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.

Benefits
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)

Characteristics
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.

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.

Dosage
Presentation:
Pack containing 100 film-coated tablets in blister
Dosage / Administration: 
If not otherwise prescribed by your doctor:

 Adult: 4-8 tablets 3 times daily during meals

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