Ketosteril

Ketosteril

Manufacturer:

Fresenius Kabi

Distributor:

Zuellig
/
The Glory Medicina
Full Prescribing Info
Contents
Ketoanalogues, amino acids.
Description
Each film-coated tablet contains (RS)-3-methyl-2-oxovaleric acid (α-ketoanalogue to DL-isoleucine), calcium-salt 67 mg; 4-methyl-2-oxovaleric acid (α-ketoanalogue to leucine), calcium-salt 101 mg; 2-oxo-3-phenylpropionic acid (α-ketoanalogue to phenylalanine), calcium-salt 68 mg; 3-methyl-2-oxobutyric acid (α-ketoanalogue to valine), calcium salt 86 mg; (RS)-2-hydroxy-4-methylthio-butyric acid (α-hydroxyanalogue to DL-methionine), calcium salt 59 mg; L-lysine acetate 105 mg corresponding to L-lysine 75 mg; L-threonine 53 mg; L-tryptophan 23 mg; L-histidine 38 mg; L-tyrosine 30 mg.
Total nitrogen content per tablet: 36 mg. Calcium content per tablet: 1.25 mmol=50 mg. It also contains the following excipients: Cornstarch, crospovidone, talc, anhydrous colloidal silica, magnesium stearate, macrogol 6000, quinoline yellow E104, basic butylated methacrylate copolymer, triacetine, titanium dioxide E171, povidone K-value 29-32.
Action
Pharmacotherapeutic Group: Amino acids, including combinations with polypeptides. ATC Code: V06DD.
Pharmacology: Pharmacodynamics: Ketosteril tablets are administered for nutrition therapy in chronic kidney disease.
Ketosteril allows the intake of essential amino acids while minimising the amino-nitrogen intake.
Following absorption, the keto- and hydroxyanalogues are transaminated to the corresponding essential amino acids by taking nitrogen from non-essential amino acids, thereby decreasing the formation of urea by re-using the amino group. Hence, the accumulation of uraemic toxins is reduced. Keto- and hydroxy- acids do not induce hyperfiltration of the residual nephrons. Ketoacid-containing supplements exert a positive effect on renal hyperphosphatemia and secondary hyperparathyroidism. Moreover, renal osteodystrophy may be improved. The use of Ketosteril in combination with a very low protein diet allows to reduce nitrogen intake while preventing the deleterious consequences of inadequate dietary protein intake and malnutrition.
Pharmacokinetics: The plasma kinetics of amino acids and their integration in metabolic pathways are well established. It should nevertheless be noted that in uraemic patients, the cause of the changed plasma levels which occur frequently in these patients, does not seem to be the absorption of the supplied amino acids (ie, the absorption itself is not disturbed). The changed plasma levels seem to be due to impaired post-absorptive kinetics, which can be detected in a very early stage of the disease.
In healthy individuals, the plasma levels of ketoacids increase within 10 min after oral administration. Increases of up to 5-fold the baseline levels are achieved. Peak levels occur within 20-60 min and after 90 min, levels stabilise in the range of the base levels. Gastrointestinal absorption is thus very rapid. The simultaneous increase in levels of the ketoacids and the corresponding amino acids show that the ketoacids are transaminated very rapidly. Due to the physiological utilisation pathways of ketoacids in the body, it is likely that exogenously supplied ketoacids are very rapidly integrated into metabolic cycles. Ketoacids follow the same catabolic pathways as the classical amino acids. No specific study on ketoacid excretion has been performed to date.
Toxicology: Preclinical Safety Data: Preclinical data reveal no special hazard for humans based on conventional studies on pharmacological safety, acute and repeated dose toxicity, reproduction toxicity and genotoxicity. Ketosteril does not show teratogenic properties.
Indications/Uses
Prevention and treatment of damages due to faulty or deficient protein metabolism in chronic kidney disease in connection with a limited dietary protein intake of ≤40 g/day (for adults) ie, generally in patients with a glomerular filtration rate (GFR) <25 mL/min.
Dosage/Direction for Use
Adults (70 kg body weight): Take 4-8 tablets 3 times daily during meals.
Ketosteril is given as long as the GFR is <25 mL/min and concomitantly, dietary protein is restricted to ≤40 g/day (for adults).
Children: There is no experience in children (see Precautions).
Administration: For oral use. The tablet must not be chewed.
Overdosage
No case of overdose has been reported.
Contraindications
Hypersensitivity to amino acids or to any of the excipients of Ketosteril.
Hypercalcaemia; disturbed amino acid metabolism.
Special Precautions
The serum calcium level should be monitored regularly.
Ensure sufficient calorie intake.
In the presence of hereditary phenylketonuria, attention should be given to the fact that Ketosteril contains phenylalanine.
Monitoring of serum phosphate levels is needed in case of concomitant administration of aluminum hydroxide (see Interactions).
Effects on the Ability to Drive or Operate Machinery: Ketosteril has no influence on the ability to drive and use machines.
Use in pregnancy & lactation: There are no adequate data from the use of Ketosteril in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Caution should be exercised when prescribing to pregnant women.
No experience has been made so far with the use during lactation.
Use in children: No experience has been made so far with the administration in paediatric patients.
Use In Pregnancy & Lactation
There are no adequate data from the use of Ketosteril in pregnant women.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see Pharmacology: Toxicology: Preclinical Safety Data under Actions).
Caution should be exercised when prescribing to pregnant women.
No experience has been made so far with the use during lactation.
Adverse Reactions
Adverse effect frequencies are ranked as follows: Very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000), not known (cannot be estimated from the available data). Metabolism and Nutrition Disorders: Very Rare: Hypercalcaemia.
If hypercalcaemia occurs, the intake of vitamin D should be reduced. In case of persisting hypercalcaemia, the dose of Ketosteril as well as the intake of any other calcium sources has to be reduced (see Interactions).
Drug Interactions
Concomitant administration of calcium-containing drugs may cause or aggravate elevated serum calcium levels.
Drugs that form hardly soluble compounds with calcium (eg, tetracyclines, quinolines eg, ciprofloxacin and norfloxacin, drugs containing iron, fluoride or estramustine) should not be taken at the same time with Ketosteril to avoid disturbed absorption of the active substances. An interval of at least 2 hrs should elapse between the ingestion of Ketosteril and these drugs.
The susceptibility to cardioactive glycosides and hence, the risk for arrhythmia will increase if Ketosteril produces elevated serum calcium levels (see Adverse Reactions).
Uraemic symptoms improve under therapy with Ketosteril. Thus, in case of aluminum hydroxide administration, the dose of Ketosteril has to be reduced, if necessary. Serum phosphate levels should be monitored for a decrease.
Incompatibilities:
Not Applicable.
Storage
Do not store above 25°C. Protect from moisture.
Shelf-Life: 3 years.
ATC Classification
V06DD - Amino acids, incl. combinations with polypeptides ; Used as general nutrients.
Presentation/Packing
FC tab (oblong, yellow) 100's.
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