Ketosteril tabs #100

Instruction for Ketosteril

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Ketosteril is a combined remedy of ketone analogs of amino acids used in renal failure.

Release form and composition

Dosage form - tablets, film-coated: oblong biconvex, yellow (20 pcs. In blisters, 5 blisters sealed in polyvinyl chloride bags, 1 bag in a cardboard box).
Content of active ingredients of Ketosteril in 1 tablet:
    Leucine alpha-ketoanalogue (methyl-4-oxo-2-calcium valerinate) - 101 mg;
    Isoleucine alpha-ketoanalogue (DL-methyl-oxo-2-calcium valerinate) - 67 mg;
    Phenylalanine alpha-ketoanalogue (oxo-2-phenyl-3-calcium propionate) - 68 mg;
    Valina alpha-ketoanalogue (methyl-oxo-2-calcium butyrate) - 86 mg;
    Methionine alpha-hydroxyanalogue (DL-hydroxy-2-calcium methylbutyrate) - 59 mg;
    L-threonine - 53 mg;
    L-lysine monoacetate - 105 mg;
    L-tryptophan - 23 mg;
    L-tyrosine - 30 mg;
    L-Histidine 38 mg
Auxiliary components: povidone, corn starch, colloidal silicon dioxide, macrogol 6000, magnesium stearate, soluble povidone, talc.
Shell composition: macrogol 6000, copolymer of methyl methacrylate, butyl methacrylate and dimethylaminoethyl methacrylate (Eudragit E12.5), triacetin, titanium dioxide, talc, quinoline yellow (E104).
The total nitrogen content is 36 mg, calcium is 50 mg.

Pharmacodynamics

Ketosteril provides a complete supply of essential amino acids to the body, while the amount of nitrogen introduced from outside is minimal. Ketone analogs of amino acids are involved in the processes of enzymatic transamination, being converted into the corresponding L-amino acids. The process is also accompanied by the breakdown of urea. The drug ensures the utilization of nitrogen-containing metabolic products and promotes protein anabolism while reducing the content of urea in the serum.
Ketosteril improves nitrogen metabolism and reduces the level of phosphate, magnesium and potassium ions in the blood. With the systematic administration of the drug, there is an improvement in the condition of patients with chronic renal failure. In some cases, it is possible to postpone the start of the dialysis procedure for some time.

Pharmacokinetics

There is no information on the pharmacokinetics of Ketosteril due to the multicomponent composition.

Indications for use

According to the instructions, Ketosteril is indicated for the prevention and treatment of protein-energy malnutrition, which has arisen against the background of altered protein metabolism in patients with protein restriction in the diet and chronic renal failure.
The drug is mainly intended for patients with a glomerular filtration rate of less than 25 ml / min, but the drug can be taken at a glomerular filtration rate of 25 ml / min or more.

Contraindications

    Disorders of amino acid metabolism;
    Hypercalcemia;
    The period of pregnancy and breastfeeding (due to the lack of clinical experience of use);
    Age up to 3 years;
    Hypersensitivity to the components of the drug.
When prescribing to patients with hereditary phenylketonuria, it is necessary to take into account the content of phenylalanine in the preparation.

Instructions for use: method and dosage

Ketosteril tablets are taken orally, during meals, swallowing whole, without chewing.
The dose of the drug is prescribed by the doctor on the basis of clinical indications, taking into account the patient's weight.
The recommended dosage regimen for patients over 3 years old: at the rate of 1 tablet for every 5 kg of body weight per day or 100 mg per 1 kg of body weight per day. Usually, with a body weight of 70 kg, the dose is 4-8 tablets 3 times a day.
The drug should be continued for the entire period as long as the glomerular filtration rate is below 25 ml / min.
Recommended protein content in food:
    Children 3-10 years old: 1.4-0.8 g per 1 kg of body weight per day;
    Over 10 years: 1-0.6 g per 1 kg of body weight per day.
Considering the degree of chronic renal failure in patients on dialysis, in the pre-dialysis period, the protein content in food should not exceed 40 g per day; in between procedures, the protein intake rate should strictly comply with the recommendations.

Side effects

Against the background of the use of Ketosteril, in some cases, the development of hypercalcemia is possible.

Special instructions

In case of hypercalcemia, it is recommended to reduce the dose of vitamin D used, if this measure is insufficient, it is necessary to reduce the dose of Ketosteril and other calcium-containing drugs.
Treatment should be accompanied by regular monitoring of calcium levels and a decrease in serum phosphate levels.
Taking the drug with meals improves its absorption and conversion into the corresponding amino acids.
Throughout the entire period of treatment, the patient should be provided with food with sufficient calories.
In case of hypersensitivity to the components of the drug, allergic reactions may develop.

Application during pregnancy and lactation

There is not enough experience in clinical studies of the use of Ketosteril during pregnancy and breastfeeding.

Childhood use

In children, the use of Ketosteril tablets is allowed according to indications and in doses selected taking into account the patient's age.

Drug interactions

It is recommended to reduce the dose of simultaneously used aluminum hydroxide as the uremic symptoms decrease under the influence of Ketosteril.
It is necessary to control the degree of decrease in the content of phosphates in the blood serum.
An interval of at least two hours should be observed between taking Ketosteril and drugs that form difficultly soluble compounds with calcium, including quinolones, tetracyclines, iron-containing drugs, estramustine, fluoride (this will not disturb absorption in the intestine).

Terms and conditions of storage

Keep out of the reach of children.
Store in a dark, dry place at temperatures up to 25 ° C.
Shelf life is 3 years.

Reviews

According to reviews, Ketosteril contributes to a gradual improvement in well-being, confirmed by laboratory tests.
Negative reviews of the drug are extremely rare, but some users claim that their condition improved too slowly. Perhaps this was due to the severity of the disease.

Terms of sell

You don't need a prescription to buy Ketosteril.