Amino Acid Keto Analogues tablets are administered for nutrition therapy in chronic kidney disease. Amino Acid Keto Analogues allow the intake of essential amino acids while minimizing the amino-nitrogen intake. The use of Amino Acid Keto Analogues in combination with a very low protein diet allows reducing nitrogen intake while preventing the deleterious consequences of inadequate dietary protein intake and malnutrition.

One film-coated tablet contains:

• Isoleucine USP 67 mg
• Leucine USP 101 mg
• Phenylalanine USP 68 mg
• Valine USP 86 mg
• Methionine USP 59 mg
• Lysine Hydrochloride USP 93.705 mg eq. to Lysine 75 mg
• Threonine USP 53 mg
• Tryptophan USP 23 mg
• Histidine USP 38 mg
• Tyrosine USP 30 mg

Prevention and treatment of damages due to faulty or deficient protein metabolism in chronic kidney disease in connection with a limited dietary protein intake of 40 g/day or less (adult). Usually, this applies to patients whose glomerular filtration rate (GFR) is less than 25 mL/min.

Adult dose (70 kg body weight): 4 to 8 tablets three times daily during meals. The tablets must not be chewed. Ingestion during meals facilitates proper absorption and the metabolization into the corresponding amino acids.

Pediatric population: No experience has been gained so far with the administration in pediatric patients.

Hypersensitivity to the active substances or to any of the excipients, Hypercalcaemia, Disturbed amino acid metabolism.

Hypercalcaemia (Very Rare), If hypercalcaemia occurs, the intake of vitamin D should be reduced. In case of persisting hypercalcaemia, the dose of Amino Acid Keto Analogues as well as the intake of any other calcium sources has to be reduced.

Pregnancy & Lactation

There are no adequate data from the use of Amino Acid Keto Analogues in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. Caution should be exercised when prescribing to pregnant women. No experience has been made so far with the use during lactation.

Precautions & Warnings

The serum calcium level should be monitored regularly

• Ensure sufficient calorie intake
• In the presence of hereditary phenylketonuria, attention should be given to the fact that Amino Acid Keto Analogues contains phenylalanine
• Monitoring of the serum phosphate levels is needed in case of concomitant administration of aluminium hydroxide