Ketosteril

Ketosteril

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig
Full Prescribing Info
Contents
Ketoanalogues, nitrogen-free essential amino acids.
Description
Each tablet contains calcium-3-methyl-2-oxo-valerate (α-ketoanalogue to isoleucine, calcium salt) 67 mg, calcium-4-methyl-2-oxo-valerate (α-ketoanalogue to leucine, calcium salt) 101 mg, calcium-2-oxo-3-phenyl-propionate (α-ketoanalogue to phenylalanine, calcium salt) 68 mg, calcium-3-methyl-2-oxo-butyrate (α-ketoanalogue to valine, calcium salt) 86 mg, calcium-dl-2-hydroxy-4-(methylthio)butyrate (α-hydroxyanalogue of methionine, calcium salt) 59 mg, L-lysine acetate (equivalent to L-lysine 75 mg) 105 mg, L-threonine 53 mg, L-tryptophan 23 mg, L-histidine 38 mg and L-tyrosine 30 mg. The total nitrogen/tablet content is 36 mg and the calcium/tablet content is 1.25 mmol which is equivalent to 0.05 g.
Indications/Uses
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/day (for adults) and less; ie, generally in patients with a glomerular filtration rate (GFR) < 25 mL/min.
Dosage/Direction for Use
For oral use.
Adults 70 kg body weight: Take 4-8 tabs 3 times a day during meals if not otherwise prescribed. Swallow whole.
Duration of Treatment: Ketosteril tablets are given as long as the glomerular filtration rate is between 5 and about 15 mL/min. Simultaneously, food should contain 40 g/day protein or less in adults.
Contraindications
Hypercalcemia, disturbed amino acid metabolism.
Special Precautions
Use in pregnancy: No experience has been made so far with the application in pregnancy.
Use in children: No experience has been made so far with the application in pediatrics.
Side Effects
Hypercalcemia. Monitor regularly the serum calcium level. Ensure the sufficient supply with calories.
Drug Interactions
The simultaneous administration of medications containing calcium (eg, acetolyte) may lead to pathological increases of the serum calcium level or intensification. As the uremia symptoms improve with Ketosteril, a possible administration of aluminium hydroxide should be reduced. Pay attention to a reduction of serum phosphate. In order not to interfere with absorption, do not take drugs together with Ketosteril that form sparingly soluble compounds with calcium (eg, tetracyclines).
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Other Drugs Acting on the Genito-Urinary System
ATC Classification
V06DD - Amino acids, incl. combinations with polypeptides ; Used as general nutrients.
Presentation/Packing
Form
Ketosteril FC tab
Packing/Price
100's
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