Ketosteril is a preparation of ketone analogues of amino acids; combined means providing the body with essential amino acids with minimal nitrogen intake, facilitating the utilization of nitrogen-containing metabolic products and anabolism of proteins, improving nitrogen metabolism, reducing the concentration of urea, magnesium ions, potassium and phosphorus in the blood. It is used for renal failure.
Release form and composition
Ketosteril is available in the form of film-coated tablets of yellow color (20 pieces in blisters, 5 blisters in sealed bags, in a cardboard bundle 1 packet).
Active ingredients of the drug (in 1 tablet):
- L-lysine monoacetate - 105 mg;
- Leucine α-keto-analogue (methyl 4-oxo-2-calcium valerinate) - 101 mg;
- Valina α-keto-analog (methyl-oxo-2-calcium butyrate) - 86 mg;
- Phenylalanine α-keto analogue (oxo-2-phenyl-3-calcium propionate) - 68 mg;
- Isoleucine α-ketoanalog (DL-methyl-oxo-2-calcium valerinate) - 67 mg;
- Methionine α-hydroxy-analogue (DL-hydroxy-2-calcium methylbutyrate) - 59 mg;
- L-threonine - 53 mg;
- L-histidine - 38 mg;
- L-tyrosine - 30 mg;
- L-Tryptophan - 23 mg.
The total nitrogen content is 36 mg. The calcium content is 50 mg (1.25 mmol).
Auxiliary components: soluble povidone, povidone, macrogol 6000, colloidal silicon dioxide, talc, corn starch, magnesium stearate.
The composition of the shell: a copolymer of dimethylaminoethyl methacrylate, butyl methacrylate and methyl methacrylate (Eudragit E12.5), titanium dioxide, triacetin, macrogol 6000, talc, dye quinoline yellow (E104).
Indications for use
Ketosteril prescribed for adults and children over 3 years. Indications for use - protein-energy failure, prevention and treatment of disorders that have developed as a result of altered protein metabolism in chronic renal failure and in case of insufficient intake of protein in the body with food.
- Disruption of amino acid metabolism;
- Hypersensitivity to the drug.
Ketosteril contains phenylalanine, so caution should be exercised when prescribing it to patients with hereditary phenylketonuria.
Dosing and Administration
The drug must be taken orally during a meal, swallowing the pill whole, not chewed and not breaking.
The daily dose is divided into 3 doses. It is calculated in accordance with the patient's weight - at the rate of 1 tablet for every 5 kg of body weight or 100 mg / kg. Adults with a weight of 70 kg are prescribed 4-8 tablets 3 times a day.
Ketosteril should be taken for the entire period until the glomerular filtration rate reaches 25 ml / minute.
During the use of the drug must take into account the protein content in food. During the period before dialysis, its amount should not exceed 40 g per day (a more accurate volume is determined depending on the degree of chronic renal failure). During dialysis, the rate of protein intake is determined by the doctor.
The recommended daily protein content in food for children:
- From 3 to 10 years - 1.4-0.8 g / kg;
- Over 10 years old - 1-0.6 g / kg.
Basically, the drug is well tolerated, in some cases, may develop hypercalcemia.
In case of hypersensitivity to any component there is a possibility of allergic reactions.
Cases of Ketosteril overdose are unknown.
Ketosteril is intended primarily for patients whose glomerular filtration rate is less than 25 ml per minute, but the use of the drug at a glomerular filtration rate of more than 25 ml / minute is not excluded.
Patients with hypercalcemia are advised to reduce the dose of vitamin D taken. If the disorder persists, reduce the dose of Ketosteril and calcium intake from other sources.
The entire period of treatment requires the control of calcium and phosphate levels in the serum. It is important to ensure sufficient caloric intake.
Clinical experience with Ketosteril during pregnancy and lactation is insufficient.
As the severity of uremic symptoms decreases under the influence of Ketosteril, the dose of aluminum hydroxide used simultaneously is reduced accordingly.
At the same time taking calcium supplements, it is possible to increase the level of this mineral substance in blood serum.
In order not to impair the absorption of Ketosteril in the intestine, tablets should not be taken in combination with agents that, when interacting with calcium, form poorly soluble compounds (for example, quinolones, tetracyclines and preparations containing estramustine, fluorine and iron). If necessary, such a combination between receptions should be kept at least 2-hour intervals.
The entire period of treatment should be monitored to reduce the level of phosphate in the serum.
Terms and conditions of storage
Store at temperatures up to 25 ºC in a dry, dark place. Keep out of the reach of children!
Shelf life - 3 years.