Tradename
Ketosteril
Generic Name
Category
Dietary Supplements
Form
Tablets
Composition
Each tablet contains:
(DL)-3-methyl-2-oxovaleric acid.......................67 mg
4-methyl-2-oxovaleric acid............................101 mg
2-oxo-3-phenyl propionic acid.........................68 mg
3-methyl-2-oxobutyric acid.............................86 mg
(DL)-2-hydroxy-4-methylthiobutyric acid...........59 mg
L-Lysine monoacetate..................................105 mg
L-Threonine..................................................53 mg
L-Tryptophan................................................23 mg
L-Histidine....................................................38 mg
L-Tyrosine....................................................30 mg
Total nitrogen content/tablet...........................36 mg
Total calcium content/tablet............................0.05 g
Description
Protein supplementation in chronic renal insufficiency
Properties/Actions
Indications
Ketosteril is used in prevention and therapy of damages due to faulty or deficient portein metabolism in chronic renal insufficiency in connection with limited protein in food to 40 grams per day (for adults) and less; i.e. generally in patients with a glomerular filtration rate (GFR) below 25 ml/min.
Contraindications
Hypercalcemia, disturbed amino acid metabolism.
In case of hereditary phenylketonuria, it has to be taken into account that Ketosteril contains phenylalanine.
Drug Interactions
The simultaneous administration of medicaments containing calcium (e.g. acetolyte) may lead to pathological increases of the serum calcium level or intensification thereof.
As the uremic symptoms improve under Ketosteril, a possible administration of aluminum 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 (e.g. tetracyclines, chinolone like ciprofloxacin and norfloxacin, iron-, fluoride- and estramustin-containing drugs). Between the intake of Ketosteril tablets and drugs from the mentioned categories a period of at least 2 hours should pass.
If the blood calcium concentration raises by the intake of Ketosteril, the susceptibility towards certain drugs enhancing the heart strength (heart/cardiac-active glycosides) will increase and the risk of heart rhythm disturbance will increase.
Side Effects/Adverse Effects
Hypercalcemia may develop. Serum calcium level should thus be monitored regularly.
Pregnancy & Lactation
Dosage & Administration
Ketosteril tablets are intended for oral use.
Unless otherwise prescribed, 4 to 8 tablets should be taken three times daily during meals. Swallowed as a whole. This dosage applied to adults (70 kg/BW).
Ketosteril tablets are given as long as the glomerular filtration rate is below 25 ml/minute. Simultaneously, food should contain 40 g/day protein or less (adults).
Overdosage
Warnings
Notes
Ensure sufficient calories are supplied.
Storage
Store at a temperature not exceeding 25°C.
Packaging
Pack of 100 or 300 film-coated tablets.
Manufacturer
Fresenius Kabi
Date Added/Updated
6th November 2011 7:23pm

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