Amino Acid Ketoanalogues tablets are indicated for the prevention and management of disorders caused by impaired or deficient protein metabolism in patients with chronic kidney disease. They are used in combination with a restricted protein diet (40 g/day or less in adults). This is generally applicable to patients with a glomerular filtration rate (GFR) below 25 ml/min.

Each film-coated tablet contains:

• Calcium-3-methyl-2-oxo-valerate (α-ketoanalogue of isoleucine, calcium salt): 67 mg
• Calcium-4-methyl-2-oxo-valerate (α-ketoanalogue of leucine, calcium salt): 101 mg
• Calcium-2-oxo-3-phenylpropionate (α-ketoanalogue of phenylalanine, calcium salt): 68 mg
• Calcium-3-methyl-2-oxobutyrate (α-ketoanalogue of valine, calcium salt): 86 mg
• Calcium-DL-2-hydroxy-4-(methylthio) butyrate (α-hydroxy analogue of methionine, calcium salt): 59 mg
• L-lysine acetate USP (equivalent to Lysine 75 mg): 105 mg
• L-threonine USP: 53 mg
• L-tryptophan USP: 23 mg
• L-histidine USP (as Histidine Hydrochloride Monohydrate): 38 mg
• L-tyrosine USP: 30 mg

This nutritional supplement contains essential amino acids, partly in the form of their corresponding ketoanalogues, specifically designed for patients with chronic kidney disease. It follows similar metabolic pathways as amino acids and works by improving protein metabolism, thereby supporting kidney function. Amino Acid Ketoanalogues allow the intake of essential amino acids while minimizing nitrogen intake. The keto- and hydroxy-analogues are converted into their corresponding essential amino acids through transamination by utilizing nitrogen from non-essential amino acids. This process reduces urea formation by recycling the amino group and promotes better metabolic balance.

• In general, unless prescribed otherwise, take 4-8 tablets 3 times a day during meals. This dosage applies to adults (with 70 kg body weight).
• Swallow whole. The tablets must not be chewed.
• Food should contain 40 g/day protein or less (adults).
• Ingestion during meals facilitates proper absorption and the metabolisation into the corresponding amino acids.
• These tablets are given as long as the GFR is between 5 and about 25mL/minute.

• Concurrent use of calcium-containing medications may increase or worsen elevated serum calcium levels.
• When aluminum hydroxide is administered, dose adjustment of this product may be required.
• Medicines that form insoluble complexes with calcium—such as tetracyclines, quinolone antibiotics (e.g., ciprofloxacin, norfloxacin), and drugs containing iron, fluoride, or estramustine—should not be taken simultaneously with Amino Acid Ketoanalogues, as this may reduce absorption. A minimum interval of 2 hours should be maintained between these medications.
• Use with cardioactive glycosides may increase sensitivity and raise the risk of cardiac arrhythmias.
• Serum phosphate levels should be monitored when used together with aluminum hydroxide.

Hypersensitivity to the active ingredients or any excipients Hypercalcemia Disorders of amino acid metabolism

Hypercalcemia (very rare) may occur. If this happens, vitamin D intake should be reduced. If hypercalcemia persists, the dose of Amino Acid Ketoanalogues and other calcium sources should also be decreased.

There are no sufficient clinical data regarding the use of Amino Acid Ketoanalogues in pregnant women. Animal studies have not shown harmful effects on pregnancy, fetal development, or postnatal growth. However, caution should be exercised during pregnancy. There is no available data regarding its use during lactation.

• Serum calcium levels should be monitored regularly
• Ensure adequate calorie intake
• In patients with phenylketonuria, consider that this product contains phenylalanine
• Monitor serum phosphate levels when used with aluminum hydroxide

Other genito-urinary preparations

Store below 30°C in a dry place. Protect from light and moisture.