Ketoaminol, 100 pcs.

Pharmacotherapeutic group: renal failure treatment.

ATX code: V06DD

Pharmacological properties

Pharmacodynamics

Ketoaminol® is used in renal failure as a nutritional agent.

Ketoaminol® provides an intake of essential amino acids while minimizing nitrogen intake. After absorption, keto- and hydroxy acids can be transaminated to form their respective essential amino acids, with the amino group transferred from the substituted amino acids. Because of the reuse of the amino group, urea formation is slowed and the accumulation of uremic toxins is reduced. Keto- and hydroxyacids do not cause hyperfiltration in the remaining nephrons.

Keto supplements have a positive effect on renal hyperphosphatemia and secondary hyperparathyroidism. Moreover, it is possible to improve the course of osteodystrophy. Administration of Ketoaminol® together with a very low-protein diet reduces nitrogen intake while preventing adverse events due to malnutrition and insufficient protein intake with food.

Pharmacokinetics

The plasma kinetics of amino acids and their incorporation into metabolic pathways are well understood. It should be noted that absorption processes in uremic patients taking amino acids do not appear to disrupt their plasma concentrations, i.e., absorption is not impaired. Changes in plasma concentrations probably occur at stages following amino acid absorption; they are detected early in the disease.

The plasma concentrations of ketoacids in healthy volunteers increase within 10 minutes of oral administration. Individual ketoacid concentrations are increased up to five times of baseline. Maximum plasma concentrations are reached within 20-60 min, after 90 min, concentrations return to baseline. Thus, absorption from the gastrointestinal tract is very rapid. The simultaneous increase in plasma concentrations of keto acids and the corresponding amino acids indicates a high rate of transamination. Because of the physiological pathways of ketoacid utilization in the body, exogenous ketoacids appear to be rapidly incorporated into metabolic cycles. Keto acids undergo the same catabolic pathways as normal amino acids. No separate study of ketoacid excretion has been performed.

Indications

Prevention and treatment in adults of disorders due to abnormal protein metabolism in chronic renal failure, with simultaneous adherence to a low-protein diet not exceeding 40 g of protein per day in adults. The glomerular filtration rate (GFR) in these patients is usually less than 25 ml/min.

Active ingredient

Keto analogs of amino acids

Composition

Composition per tablet:

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How to take, the dosage

For oral administration.

Adults – 1 tablet per 5 kg of body weight per day or 0.1 g/kg of body weight per day. The usual daily dose for an adult (body weight 70 kg) is 4-8 tablets 3 times a day (in whole) with meals. Administration with food improves absorption and metabolism to appropriate amino acids.

Duration of use: Ketoaminol® is used until FFR does not exceed 25 ml/min and the patient follows a low-protein diet containing not more than 40 g of protein per day (in adults).

Interaction

Simultaneous use with calcium medications may lead to hypercalcemia or intensify it.

In order not to impair absorption in the intestine, Ketoaminol® should not be taken together with drugs that can form with calcium insoluble compounds (e.g., tetracyclines, quinolone derivatives such as Ciprofloxacin and Norfloxacin; drugs of iron, fluorine and estramustine). At least a 2-hour interval should be observed between the intake of Ketoaminol® and such drugs. Sensitivity to cardiac glycosides, and therefore the risk of arrhythmias, increases as serum calcium concentration increases (see section “Side effects”).

As uremic symptoms decrease under the influence of Ketoaminol® , the dose of prescribed aluminum hydroxide should be reduced. Serum phosphate concentration should be monitored.

Special Instructions

Serum calcium concentrations should be monitored regularly.

A sufficient caloric intake is necessary.

When used concomitantly with aluminum hydroxide serum phosphate concentrations should be monitored (see section “Interaction with other medicinal products”).

Influence on performance of potentially hazardous activities requiring special attention and rapid reaction time

Ketoaminol® has no effect on the ability to drive and engage in other potentially hazardous activities requiring increased concentration and rapid psychomotor reaction.

Contraindications

Hypersensitivity to the drug components; impaired amino acid metabolism; hypercalcemia.

Patients with hereditary phenylketonuria should take into account that the drug contains phenylalanine.

Child and adolescent age under 18 years (due to lack of experience in pediatric practice).

Side effects

Unwanted side effects were grouped by organ and frequency of occurrence. Frequency was defined as: very common >10%, common 1-10%, infrequent 0.1-1%, rare 0.01-0.1%, very rare <0.01%, frequency unknown (cannot be estimated based on available data).

Metabolism and nutrition

Very rare: hypercalcemia.

In this case, it is recommended to reduce the dose of vitamin D. If hypercalcemia persists, the dose of Ketoaminol® and other calcium sources should be reduced.

Pregnancy use

There are no clinical data on the use of the drug Ketoaminol® in pregnant women. In preclinical studies no direct or indirect harm to pregnancy, embryo-fetal development, childbirth and postnatal development was found.

The drug should be used with caution during pregnancy.

No experience of use during breastfeeding.