Ketosteril^® (Tablets) Instructions for Use

ATC Code

V06DD (Amino acids, including combinations with polypeptides)

Clinical-Pharmacological Group

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

Pharmacotherapeutic Group

Therapeutic nutrition; other therapeutic nutrition products; amino acids, including combinations with polypeptides

Pharmacological Action

A combined medicinal product. It provides a complete supply of essential amino acids with minimal nitrogen intake. The keto analogues of amino acids are enzymatically transaminated in the body into the corresponding L-amino acids, simultaneously breaking down urea.

It promotes the utilization of nitrogenous metabolic products and protein anabolism while reducing the serum urea concentration. It improves nitrogen metabolism. It reduces the concentration of potassium ions, magnesium, and phosphate in the blood.

Systematic use of this medicinal product has been noted to improve the condition of patients with chronic renal failure. In some cases, it is possible to delay the initiation of dialysis.

Indications

Protein-energy malnutrition, prevention and treatment of disorders caused by altered protein metabolism in chronic renal failure and during dietary protein restriction (in adults and children aged 3 years and older).

Primarily for patients with a GFR <25 ml/min, which does not exclude use at GFR ≥25 ml/min.

ICD codes

Dosage Regimen

Tablets

Orally, usually 3 times/day with meals.

Adults and children aged 3 years and older are prescribed 1 tablet/5 kg of body weight/day or 100 mg/kg of body weight/day. For adults with a body weight of 70 kg, the dose is usually 4-8 tablets 3 times/day.

It is used throughout the period when the GFR is less than 25 ml/min.

In the pre-dialysis period, it is recommended that the dietary protein content does not exceed 40 g/day, depending on the degree of chronic renal failure.

In patients on dialysis, protein intake should comply with accepted recommendations.

The recommended dietary protein content for children 3-10 years old is 1.4-0.8 g/kg/day, for children over 10 years old – 1-0.6 g/kg/day.

Adverse Reactions

Metabolism in individual cases – hypercalcemia.

Contraindications

Hypercalcemia; disorders of amino acid metabolism; hypersensitivity to the components included in the dosage form of the drug used.

In hereditary phenylketonuria, it should be taken into account that the dosage form of the drug used may contain phenylalanine.

Use in Pregnancy and Lactation

Clinical experience with use during pregnancy and breastfeeding is insufficient.

Use in Renal Impairment

Primarily for patients with a glomerular filtration rate of less than 25 ml/min (however, use at a glomerular filtration rate of more than 25 ml/min is not excluded).

Pediatric Use

Can be used in children aged 3 years and older according to indications and in doses taking into account the age of the patients.

Special Precautions

In case of hypercalcemia, it is recommended to reduce the dose of vitamin D taken. If hypercalcemia persists, the dose of this medicinal product, as well as other sources of calcium, should be reduced.

It is necessary to regularly monitor the calcium content and control the decrease in phosphate levels in the blood serum.

To improve its absorption and conversion into the corresponding amino acids, this medicinal product should be taken with meals.

Sufficient caloric intake from food must be ensured.

Drug Interactions

With the simultaneous administration of medicinal products containing calcium, an increase in serum calcium levels is possible.

As uremic symptoms decrease under the influence of this medicinal product, the dose of simultaneously used aluminum hydroxide should be reduced accordingly.

A decrease in serum phosphate levels should be monitored.

In order not to impair intestinal absorption, medicinal products that form poorly soluble compounds with calcium (for example, tetracyclines, quinolones, preparations containing iron, fluoride, and estramustine) should not be taken simultaneously. The interval between doses should be at least 2 hours.

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.