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.
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