Renalog Max

White to pale yellow granular powder with pleasant flavor.
Each sachet contains: Calcium-4-methyl-2-oxovalerate (α-Ketoanalogue of leucine, Calcium salt) 303 mg, Calcium-3-methyl-2-oxobutyrate (α-Ketoanalogue of valine, Calcium salt) 258 mg, Calcium-2-oxo-3-phenylpropionate (α-Ketoanalogue of phenylalanine, Calcium salt) 204 mg, Calcium-3-methyl-2-oxovalerate (α-Ketoanalogue of isoleucine, Calcium salt) 201 mg, Calcium-DL-2-hydroxy-4-(methylthio)-butyrate (α-Hydroxyanalogue of methionine, Calcium salt) 177 mg, L-Lysine Acetate USP 315 mg, L-Threonine USP 159 mg, L-Histidine USP 114 mg, L-Tyrosine USP 90 mg, L-Tryptophan USP 69 mg, Total Nitrogen content/sachet 108 mg, Calcium/sachet 3.75 mmol⧋150 mg, Excipients q.s.
Colour: Lake of Sunset Yellow.

Pharmacological classification: Renal Nutrition Therapy (Nutrition Therapy in Chronic Kidney Disease).
Pharmacology: Pharmacodynamics: Alpha ketoanalogues + Essential Amino Acids allows the intake of essential amino acids while the intake of the amino nitrogen is minimized.
The alpha keto-analogues are transaminated after ingesting by extracting nitrogen from non-essential amino acids, therefore reducing the formation of urea by reusing the amino group.
The accumulation of uremic toxins are reduced. Hyperfiltration of remaining nephrons is not elicited by keto and/or hydroxyl-acids. Supplements containing ketoacids have a positive effect on renal hyperphosphatemia, and secondary hyperparathyroidism can help to improve renal osteodystrophy.
The usage of Alpha Ketoanalogues + Essential Amino Acids in conjunction with a very low protein diet allows for a reduction in nitrogen intake while avoiding the negative effects of a lack of dietary protein and malnutrition.
Pharmacokinetics: The plasma kinetics of essential amino acids and their integration in the metabolic pathways are well established. It should be noted that the plasma disturbances in uremic patients do not appear to be dependent on digested amino acid intake, and that the post-absorptive kinetics appears to be distributed very early in the disease's development in normal individuals. There is an increase in the plasma level of alpha ketoanalogues 10 minutes after oral ingestion. Peak levels are reached within 20-60 minutes, and normal levels are reached again after 90 minutes. Gastrointestinal absorption is hence very rapid. The simultaneous increases in the levels of Alpha Ketoanalogues + Essential Amino Acids and the corresponding amino acids indicate that the Alpha Ketoanalogues + Essential Amino Acids are very rapidly transaminated. Exogenously supplied Essential Amino Acids are expected to be very rapidly integrated into the metabolic cycle due to the physiological utilization pathways of Essential Amino Acids in the body. Ketoacids follow the same catabolic pathways as classical amino acids. No specific study on Alpha Ketoanalogues + Essential Amino Acids excretion has been performed to date.

Prevention and therapy of damages due to faulty or deficient protein metabolism in chronic renal insufficiency in connection with limited protein in food of 40 g per day (for adults) and less, i.e. generally in patients with a glomerular filtration rate (GFR) below 25 mL/min or between 5 and about 15 mL/min.

As directed by the physician.
Directions for Use: Mix the whole contents of sachet in a sufficient amount of water. Stir well and consume immediately.
Or as advised by healthcare professional.
Duration of Treatment: Formulation is given as long as the glomerular filtration rate is between 5 and about 15 mL/min. Simultaneously, food should contain 40 g/day protein or less in adults.

No specific information is available on the treatment of overdose of Alpha Ketoanalogues + Essential Amino Acids.

Hypercalcemia, disturbed amino acid metabolism. In case of hereditary phenylketonuria, it has to be taken into account that this product contains phenylalanine.

No experience has been made so far with the application in pregnancy and pediatrics. Formulation should be taken during meals to allow proper absorption and metabolism into the corresponding amino acids. The serum calcium level should be monitored regularly. An adequate supply of calories should be ensured.

There are no clinical studies established.

Hypercalcemia may develop. In this case, it is recommended to decrease vitamin D intake. If the hypercalcemia persists, reduce the dosage of formulation, as well as any other source of calcium.

Simultaneous administration of medicinal products that contain calcium (e.g. acetolyte) may trigger, or worsen, a pathological increase in the serum calcium level. As the uremic symptoms improve under therapy with formulation/sachets, the dose of aluminum hydroxide administered should be reduced, as appropriate. The patient should be monitored for reduced levels of serum phosphate. In order not to interfere with absorption, an appropriate interval should be observed between administration of formulation/sachets and medicinal products which form poorly soluble compounds with calcium (e.g. tetracyclines, quinolones such as ciprofloxacin and norfloxacin, preparations that contain iron, fluoride and estramustin). An interval of at least 2 hours should be observed between the intake of formulation/sachets and such preparations. If administration of formulation leads to increased blood levels of calcium, the sensitivity to medicinal products which increase heart action (cardiac glycosides) and thus also the risk of cardiac arrhythmia is increased.

Store at temperatures not exceeding 30°C.
Keep in a cool and dry place.
Shelf Life: 36 months.

Other Drugs Acting on the Genito-Urinary System

A16AA - Amino acids and derivatives ; Used in treatment of alimentary tract and metabolism problems.

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