Ketoamynol^® (Tablets) Instructions for Use

Marketing Authorization Holder

Pharmfirma Sotex, CJSC (Russia)

Manufactured By

Nanjing Baijingyu Pharmaceutical, Co. Ltd. (China)

Or

Pharmfirma Sotex, CJSC (Russia)

Packaging and Quality Control Release

Pharmfirma Sotex, CJSC (Russia)

ATC Code

V06DD (Amino acids, including combinations with polypeptides)

Dosage Form

Ketoamynol®

Film-coated tablets: 100 pcs.

Dosage Form, Packaging, and Composition

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

* calculated on the dry substance.

Excipients : povidone K30 – 44 mg, starch – 20 mg, microcrystalline cellulose – 10 mg, macrogol 6000 – 10 mg, crospovidone – 10 mg, magnesium stearate – 10 mg, talc – 10 mg, silicon dioxide – 4 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.

20 pcs. – contour cell packs (5) – bags (1) – cardboard packs.

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

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

After absorption, 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. Keto and hydroxy acids do not cause hyperfiltration in the remaining nephrons. Ketone-containing supplements have a positive effect on renal hyperphosphatemia and secondary hyperparathyroidism. Furthermore, 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 adverse events due to malnutrition and insufficient dietary protein intake.

Pharmacokinetics

The absorption processes in uremic patients taking amino acids apparently do not lead to impaired 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 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 rapidly 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 daily amount of protein 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.

Adhere strictly to a concomitant low-protein diet.

Determine the total daily dose individually based on patient’s body weight and dietary protein intake.

Divide the total daily dose into three equal administrations, taken with main meals.

For adults, the typical daily dose is 4 to 8 tablets per 10 kg of body weight.

For children aged 3 years and older, calculate the dose based on 1 to 2 tablets per 5 kg of body weight daily.

Adjust the final dosage based on clinical response and laboratory parameters, including serum calcium and phosphate levels.

Swallow tablets whole with a sufficient amount of liquid; do not crush or chew.

Regularly monitor serum calcium concentration to prevent hypercalcemia.

Ensure adequate caloric intake is maintained throughout therapy.

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. Use with caution during pregnancy.

There is no experience of use during breastfeeding. If the use of the agent is necessary during breastfeeding, 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

Serum calcium concentration should be monitored regularly.

Adequate caloric intake must be ensured.

When used concomitantly with aluminum hydroxide, plasma phosphate concentrations should be monitored.

Drug Interactions

Concomitant use with calcium medications may lead to or exacerbate hypercalcemia.

To avoid impairing intestinal absorption, 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 preparations). 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 plasma calcium concentration increases.

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

Against the background of the use of this agent, plasma phosphate concentrations should be monitored.

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.