Ketoaminol® (KETOAMYNOL®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbspfilm-coated tablets
Composition:For 1 tablet:

Lysine monoacetate

105.0 mg

4-methyl-2-oxo-valerate of calcium (leucine alpha-keto analog) in terms of dry matter

101.0 mg

3-methyl-2-oxo-butyrate calcium (valine alpha-keto analog) in terms of dry matter

86.0 mg

2-Oxo-3-phenyl-propionate of calcium (phenylalanine alpha-keto analogue) in terms of dry matter

68.0 mg

D,L-3-methyl-2-oxo-valerate of calcium (isoleucine alpha-keto analogue) in terms of dry matter

67.0 mg

2-Hydroxy-4-methylthio-butyrate of calcium (methionine alpha-hydroxy analogue) in terms of dry matter

59.0 mg

Threonine

53.0 mg

Histidine

38.0 mg

Tyrosine

30.0 mg

Tryptophan

23.0 mg

Excipients:

Povidone-K30

44.0 mg

Starch

20.0 mg

Microcrystalline cellulose

10.0 mg

Macrogol-6000

10.0 mg

Crospovidone

10.0 mg

Magnesium stearate

10.0 mg

Talc

10.0 mg

Silicon dioxide

4.0 mg

Shell composition:

Talc

12.4 mg

Methacrylic acid and ethyl acrylate copolymer [1: 1]

8.2 mg

Titanium dioxide

4.6 mg

Macrogol-6000

2.1 mg

Quinoline yellow dye

0.5 mg

Total nitrogen content in the tablet

36 mg

Calcium in Tablet Content

50 mg = 1.25 mmol
Description:

Oblong, biconvex tablets covered with a film coating of yellow color; the core is white or almost white in cross section.

Pharmacotherapeutic group:Renal failure treatment
ATX: & nbsp
  • Amino acids, including combinations with polypeptides
    • Pharmacodynamics:

    Ketoaminol® is used for renal failure as a nutrient.

    Ketoaminol® provides the intake of essential amino acids in the body 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 hyperphosphatemia and secondary hyperparathyroidism. Moreover, it is possible to improve the course of osteodystrophy. The use of Ketoaminol® along with a diet with a very low protein content can 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. It should be noted that 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 initial concentration. 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:

    Protein-energy insufficiency, prevention and treatment in adults and children from 3 years of violations due to pathological protein metabolism in chronic kidney failure, while simultaneously observing a low-protein diet that does not exceed the amount of protein in adults 40 g per day, 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 in the bluish. The rate of glomerular filtration (GFR) in these patients, as a rule, does not exceed 25 ml / min.

    Contraindications:

    Hypersensitivity 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:

    There are no clinical data on the use of Ketoaminol® in pregnant women. 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.

    Dosing and Administration:

    For oral administration.

    Adults and children from 3 years - 1 tablet per 5 kg body weight per day or 0.1 g / kg 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: Ketoaminol® is used until the GFR ns exceeds 25 ml / min, and the patient complies with a low-protein diet containing not more than 40 g protein per day (in adults). The recommended protein content in the niche for children from 3 to 10 years is 1.4-0.8 g / kg body weight per day, from 10 years-1-0.6 g / kg body weight per day.

    Side effects:

    Undesirable 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.

    In this case, it is recommended to reduce the dose of the vitamin D. If hypercalcemia persists, you should reduce the dose of Ketoaminol®, 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 intestinal absorption, Ketoaminol® 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 the intake of Ketoaminol® and such preparations should be maintained 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 preparation Ketoaminol®, 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 control the serum phosphate concentration (see the section "Interaction with other medicinal products").

    Effect on the ability to drive transp. cf. and fur:

    Ketoaminol® does not affect the ability to drive vehicles and engage in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.

    Form release / dosage:

    Film-coated tablets.

    Packaging:

    For 20 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil.

    For 5 contour mesh packages in a package of polyethylene terephthalate film, aluminum foil and polyethylene film.

    The package together with instructions for use 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 printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002756
    Date of registration:15.12.2014 / 25.06.2015
    Expiration Date:15.12.2019
    The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspPharm Company Sotex CJSC Pharm Company Sotex CJSC Russia
    Information update date: & nbsp02.01.2018
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