Ketoanalogues of amino acids (Ketoanalogues of aminoacids)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceKetoanalogues of amino acidsKetoanalogues of amino acids
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  • Ketoanalogues of amino acids
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    ALVILS, LTD.     Russia
  • Ketosteril®
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    Fresenius Kabi Deutschland GmbH     Germany
    • Dosage form: & nbspfilm-coated tablets
    Composition:

    For 1 tablet:

    Active substances: isoleucine alpha-keto analogue (ketoisoleucine calcium) - 67 mg; leucine alpha-keto analogue (ketoleucine calcium) - 101 mg; phenylalanine alpha-keto analog (ketophenylalanine calcium monohydrate) - 68 mg; valine alpha-keto analog (ketovaline calcium) - 86 mg; methionine alpha-hydroxy analogue (hydroxymethionine calcium) - 59 mg; lysine monoacetate - 105 mg; threonine - 53 mg; tryptophan - 23 mg; histidine 38 mg; tyrosine - 30 mg.

    Excipients: crospovidone - 20 mg; macrogol 6000 - 50 mg; pregelatinized starch - 50 mg; povidone-KZO - 8 mg; magnesium stearate - 4 mg.

    Film sheath: Opadray 85F620005 yellow 23 mg (polyvinyl alcohol 12.4 mg, titanium dioxide 6.6 mg macrogol 3350 1.2 mg, talc 1.0 mg, quinoline yellow color (E104) 1.8 mg).

    Description:Plong, biconvex tablets, covered with a film membrane of yellow color, on the cross section the nucleus is white or almost white.
    Pharmacotherapeutic group:Renal failure treatment
    ATX: & nbsp

    V.06.D.D.   Amino acids, including combinations with polypeptides

    Pharmacodynamics:

    Ketoanalogues of amino acids are used in renal failure as a nutrient.

    The drug provides the entry into the body of essential amino acids with a minimum supply of nitrogen.

    After absorption, keto and hydroxy acids can be transaminated to form the corresponding irreplaceable amino acids, while the amino group is transferred from the non-essential amino acids. Due to the repeated use of the amino group, urea formation slows down and the accumulation of uremic toxins decreases. Keto and hydroxy acids do not cause hyperfiltration in the remaining nephrons. Keto-containing supplements positively affect renal hyperphosphataemia and secondary hyperparathyroidism. Moreover, it is possible to improve the course of osteodystrophy. Application of the drug Ketoanalogues of amino acids together with a diet with a very low protein content, allows to reduce the intake of nitrogen, while avoiding undesirable phenomena due to malnutrition and insufficient intake of protein with food.

    Pharmacokinetics:

    Plasma kinetics of amino acids and their integration into metabolic pathways are well studied.Absorption processes in uremic patients taking amino acids apparently do not lead to a violation of their plasma concentrations, i.e. Absorption is not impaired. Changes in plasma concentrations are likely to occur at the stages following the absorption of amino acids; they are detected at an early stage of the disease.

    Plasma concentrations of keto acids in healthy volunteers increase within 10 min after ingestion. Individual concentrations of keto acids are increased up to five times from the initial ones. The maximum plasma concentrations are reached within 20-60 minutes, after 90 minutes, the concentrations return to the original concentrations. Thus, absorption from the gastrointestinal tract is very fast. Simultaneous increase in plasma concentrations of keto acids and corresponding amino acids indicates a high transamination rate. In view of the presence in the body of physiological pathways for the utilization of keto acids, exogenous keto acids appear to be rapidly integrated into metabolic cycles. Keto acids pass through the same catabolism pathways as conventional amino acids. A separate study of excretion of keto acids was not carried out.

    Indications:

    Prevention and treatment in adults and children from 3 years of violations caused by pathological protein metabolism in chronic kidney failure, while simultaneously observing a low-protein diet that does not exceed the amount of protein per day in adults 40 g, in children from 3 to 10 years - 1.4-0 , 8 g / kg body weight per day, from 10 years - 1-0.6 g / kg body weight per day. The rate of glomerular filtration (GFR) in these patients, as a rule, does not exceed 25 ml / min.

    Contraindications:

    Increased sensitivity to the components of the drug; impaired metabolism of amino acids; hypercalcemia.

    Patients with hereditary phenylketonuria should note that the drug contains phenylalanine.

    Pregnancy and lactation:

    Clinical data on the use of the drug Ketoanalogues of amino acids in pregnant women are absent. In pre-clinical studies, direct or indirect harm for pregnancy, embryo-fetal development, childbirth and postnatal development was not detected. During pregnancy, the drug should be used with caution.

    Experience with breastfeeding is absent. If treatment with Ketoanalogy is necessary during breastfeeding, then breastfeeding should be discontinued.

    Dosing and Administration:

    For ingestion.

    Adults and children from 3 years 1 tablet per 5 kg of body weight per day or 0.1 g / kg of body weight per day. The usual daily intake for an adult (body weight 70 kg) is 4-8 tablets 3 times a day (whole) with meals. Admission together with food improves absorption and metabolism to the corresponding amino acids.

    Duration of application: the drug is used until the GFR does not exceed 25 ml / min, and the patient observes a low-protein diet containing not more than 40 g protein per day (in adults).

    Recommended protein content in food for children from 3 to 10 years is 1.4-0.8 g / kg body weight per day, for children from 10 years - 1.0-0.6 g / kg body weight per day.

    Side effects:

    Unwanted Side effects are grouped by organs and frequency of occurrence. The frequency was defined as: very often> 10%, often 1-10%, infrequently 0.1-1%, rarely 0.01-0.1%, very rarely <0.01%, frequency unknown (impossible to estimate based on available data).

    From the side of metabolism and nutrition: very rarely - hypercalcemia.

    Possible development allergic reactions to the components of the drug.

    In this case, it is recommended to reduce the dose of the vitamin D. If hypercalcemia persists, the dose of the drug should be reduced Ketoanalogues of amino acids, as well as other sources of calcium.

    See section "Interaction with other medicinal products".

    Overdose:

    No cases of overdose have been reported.

    Interaction:

    Simultaneous use with calcium medications can lead to hypercalcemia or strengthen it.

    In order not to interfere with absorption in the intestine, the drug should not be taken with medicines that are able to form difficult-to-dissolve compounds with calcium (for example, tetracyclines, quinolone derivatives such as ciprofloxacin and norfloxacin; preparations of iron, fluorine and estramustine).

    Between taking the drug Ketoanalogues of amino acids and such drugs should be kept at least 2-hour interval.

    Sensitivity to cardiac glycosides, and, consequently, the risk of arrhythmias, increases with increasing serum calcium concentration (see the "Side effect" section).

    As the uremic symptoms decrease under the influence of the drug, it is necessary to reduce the dose of the designated aluminum hydroxide. Follow the serum phosphate concentration.

    Special instructions:

    Serum calcium concentration should be monitored regularly.

    It is necessary to ensure sufficient caloric content of food.

    When used simultaneously with aluminum hydroxide, it is necessary to monitor the serum concentration of phosphates (see section "Interaction with other medicinal products").

    Effect on the ability to drive transp. cf. and fur:Ketoanalogues of amino acids do not affect the ability to drive vehicles and engage in other potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:

    Film-coated tablets.

    Packaging:

    20 or 24 tablets per blister Al/ PVC.

    For 5 blisters for 20 tablets or 4 blisters for 24 tablets in a sealed packet of Al/ PVC.

    For 1 package, together with instructions for use, put in a pack of cardboard.

    Storage conditions:

    In a dry, the dark place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.

    Do not use after the expiration date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-003994
    Date of registration:05.12.2016
    Expiration Date:05.12.2021
    The owner of the registration certificate:ALVILS, LTD. ALVILS, LTD. Russia
    Manufacturer: & nbsp
    Representation: & nbspAlvils, OOOAlvils, OOO
    Information update date: & nbsp02.01.2018
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