Amino acid keto analogues film coated tablet is indicated for chronic renal insufficiency with the following conditions: Given with high calorie, low protein food <40 g daily; Compensated or decompensated retention; Glomerular filtration rate (GFR) of 5-50 mL/minute.

Amino Acid Ketoanalogue used for nutrition therapy in chronic kidney disease. In absorption process, the keto- and hydroxy-analogues are transaminated to the corresponding essential amino acids by taking nitrogen from non-essential amino acids, thereby decreasing the formation of urea by re-using the amino group. Hence, the accumulation of uraemic toxins is reduced. Amino Acid Ketoanalogue do not induce hyperfiltration of the residual nephrons. Amino Acid Ketoanalogue containing supplements exert a positive effect on renal hyperphosphataemia and secondary hyperparathyroidism. Moreover, renal osteodystrophy may be improved. The use of Amino Acid Ketoanalogue in combination with a very low protein diet allows to reduce nitrogen intake while preventing the deleterious consequences of inadequate dietary protein intake and malnutrition.

The plasma kinetics of essential amino acids and their integration in the metabolic pathways are well established. It should nevertheless be noted that in uraemic patients, the cause of the changed plasma levels, which occur frequently in these patients, does not seem to be the absorption of the supplied amino acids, i. e. the absorption itself is not disturbed. The changed plasma levels seem to be due to impaired post-absorptive kinetics, which can be detected in a very early stage of the disease. Gastrointestinal absorption is thus very rapid. The simultaneous increases in the levels of the Amino Acid Ketoanalogue and the corresponding amino acids show that the Amino Acid Ketoanalogue are transaminated very rapidly. Due to the physiological utilisation pathways of Amino Acid Ketoanalogue in the body it is likely that exogenously supplied Amino Acid Ketoanalogue are very rapidly integrated into the metabolic cycles. Ketoacids follow the same catabolic pathways as classical amino acids. No specific study on Amino Acid Ketoanalogue excretion has been performed to date.

For oral administration. Swallow whole, do not chew/crush. This dosage is for adults with Body Weight (BW) >70 kg.

• Chronic renal insufficiency: Unless otherwise prescribed, 4-8 tablets 3 times daily, taken during meals.
• Compensated retention: Unless otherwise prescribed, 4-8 tablets 3 times daily, along with low protein (500-600 mg protein/kg BW per day close to 35-45 grams) and high calorie nutrition [150-170 KJ (35-40 kcal)/kg BW per day].
• Decompensated retention: Unless otherwise prescribed, 4-8 tablets 3 times daily, along with low protein (300-400 mg protein/kg BW per day close to 20-30 grams) and high calorie nutrition [150-170 KJ (35-40 kcal)/kg BW per day].

With the alleviation of uremic symptoms by Amino Acid Ketoanalogue, reduce the use of Aluminium hydroxide. Observe the reduction of serum phosphate. Concomitant use with drugs forming poor dissolution compound in calcium (e.g. Tetracycline) can inhibit Amino Acid Ketoanalogue absorption.

Hypercalcemia, disorder of amino acid metabolism.

May cause hypercalcemia, therefore monitor the serum calcium level periodically.

Give enough calories to the patient. Concomitant use with other calcium containing drugs must be given with attention, as it may cause hypercalcemia. Therefore, the serum calcium level must be monitored periodically. Not to be given along with drugs which are slightly soluble in calcium (e.g. Tetracycline). There is no report about usage on pregnancy and children.

No specific information is available on the treatment of overdose with Amino Acid Ketoanalogue Film Coated Tablet

Other genito-urinary preparations

Store at a temperature not exceeding 30°C. Store in a dry place. Protect from heat and moisture.