Ketoanalogues of aminoacids (Tablets) Instructions for Use

Marketing Authorization Holder

Alvils, LLC (Russia)

Manufactured By

YUGPHARM, LLC (Russia)

ATC Code

V06DD (Amino acids, including combinations with polypeptides)

Dosage Form

Ketoanalogues of aminoacids

Film-coated tablets: 96 or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, oblong, biconvex; the core on the cross-section is white or almost white.

Excipients: crospovidone – 20 mg, macrogol 6000 – 50 mg, pregelatinized starch – 50 mg, povidone K30 – 8 mg, magnesium stearate – 4 mg.

Film coating: opadry 85F620005 yellow – 23 mg (polyvinyl alcohol – 12.4 mg; titanium dioxide – 6.6 mg; macrogol 3350 – 1.2 mg; talc – 1 mg; quinoline yellow dye (E104) – 1.8 mg).

20 pcs. – blisters (5) and aluminum foil – cardboard packs made of polyethylene terephthalate film, aluminum foil and polyethylene film.
24 pcs. – blisters (4) and aluminum foil – cardboard packs made of polyethylene terephthalate film, aluminum foil and polyethylene film.

Clinical-Pharmacological Group

Drug of keto analogues of amino acids, used for renal failure

Pharmacotherapeutic Group

Remedy for renal failure

Pharmacological Action

Nutritional agent for renal failure. It provides the body with essential amino acids with minimal nitrogen intake.

After absorption, the keto- and hydroxy acids can be transaminated to form the corresponding essential amino acids, with the amino group being transferred from non-essential amino acids. Due to the reuse of the amino group, the formation of urea is slowed down and the accumulation of uremic toxins is reduced. The keto- and hydroxy acids do not cause hyperfiltration in the remaining nephrons. Keto-containing supplements have a positive effect on renal hyperphosphatemia and secondary hyperparathyroidism. Moreover, improvement in the course of osteodystrophy is possible. The use of this agent with simultaneous adherence to a very low-protein diet allows for a reduction in nitrogen intake without causing undesirable phenomena due to malnutrition and insufficient protein intake with food.

Pharmacokinetics

The absorption processes in patients with uremia taking amino acids apparently do not lead to a violation of their plasma concentrations, i.e., absorption is not impaired. Changes in plasma concentrations probably occur at stages following the absorption of amino acids; they are detected at an early stage of the disease.

Individual concentrations of keto acids increase up to five times from the baseline. C_max is reached within 20-60 minutes, after 90 minutes the 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. Due to the presence of physiological pathways for the utilization of keto acids in the body, exogenous keto acids are apparently quickly incorporated into metabolic cycles. Keto acids undergo the same catabolic pathways as ordinary amino acids.

Indications

Prevention and treatment in adults and children from 3 years of age of disorders caused by pathological protein metabolism in chronic renal failure, with simultaneous adherence to a low-protein diet not exceeding the amount of protein per day in adults 40 g, in children from 3 to 10 years – 1.4-0.8 g/kg/day, from 10 years – 1-0.6 g/kg/day. The GFR in such patients, as a rule, does not exceed 25 ml/min.

ICD codes

Dosage Regimen

Administer orally with meals during the main meal times.

Adhere strictly to a concomitant low-protein diet not exceeding 40 g of protein per day for adults.

For adults, the typical daily dose is 4 to 8 tablets per 10 kg of body weight, divided into three equal doses.

The exact dosage must be individualized based on the patient’s body weight and the severity of renal impairment.

For pediatric patients aged 3 to 10 years, the daily protein intake should be restricted to 1.4-0.8 g/kg/day.

For pediatric patients over 10 years, the daily protein intake should be restricted to 1-0.6 g/kg/day.

Adjust the number of tablets for children according to body weight and the prescribed protein-restricted diet.

Do not use in children under 3 years of age.

Ensure sufficient caloric intake from food to prevent catabolism.

Regularly monitor serum calcium levels to detect and manage potential hypercalcemia.

Adverse Reactions

Metabolism disorders very rarely – hypercalcemia.

Other possibly – allergic reactions.

Contraindications

Hypersensitivity to the components of the agent; amino acid metabolism disorders; hypercalcemia.

Patients with hereditary phenylketonuria should take into account that this agent contains phenylalanine.

Use in Pregnancy and Lactation

There are no clinical data on the use of this agent in pregnant women. It should be used with caution during pregnancy.

There is no experience of use during breastfeeding. If the use of the agent is necessary during breastfeeding, then breastfeeding should be discontinued.

Use in Renal Impairment

The drug is approved for use in renal impairment

Pediatric Use

Contraindicated for use in children under 3 years of age.

Special Precautions

It is necessary to regularly monitor the serum calcium concentration.

It is necessary to ensure sufficient caloric intake of food.

With simultaneous use with aluminum hydroxide, it is necessary to monitor the plasma phosphate concentration.

Drug Interactions

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

In order not to disrupt absorption in the intestine, this agent should not be taken together with drugs capable of forming poorly soluble compounds with calcium (for example, tetracyclines, quinolone derivatives such as ciprofloxacin and norfloxacin; iron, fluoride and estramustine drugs). An interval of at least 2 hours should be observed between taking this agent and such drugs.

Sensitivity to cardiac glycosides and, consequently, the risk of arrhythmias increases as the plasma calcium concentration increases.

As the symptoms of uremia decrease under the influence of this agent, the dose of aluminum hydroxide should be reduced.

Against the background of the use of this agent, it is necessary to control the plasma phosphate concentrations.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.