Ketoalfa Tablet

Ketoalfa is indicated for prevention & treatment of damages due to faulty or deficient protein metabolism in chronic kidney disease in connection with a limited dietary protein intake 40 gm/day or less(adult). Usually this applies to patients whose glomerular filtration rate (GFR) is less than 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-hydroxyanalogue to methionine, calcium-salt): 59 mg
• L-lysine acetate USP (eqv. to Lysine 75mg) :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 amino acids, partly in form of there corresponding ketoanalogues, essential for patients with chronic kidney disease. It follows same catabolic pathways as amino acids and works by improving the metabolism of protein in the body, thereby improving the renal function. Amino Acid Ketoanalogues allows the intake of essential amino acids while minimizing the amino-nitrogen intake. 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, and causes absorption to occur.

• 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.

• Concomitant administration of calcium-containing drugs may cause or aggravate elevated serum calcium levels.
• In case of aluminum hydroxide administration, the dose of Ketoalfa has to be reduced if necessary.
• Drugs that form hardly soluble compounds with calcium (e.g., tetracyclines, quinolones such as ciprofloxacin and norfloxacin as well as drugs containing iron, fluoride or estramustine) should not be taken at the same time with Ketoalfa acid keto analogue to avoid disturbed absorption of the active substance. An interval of at least two hours should elapse between the ingestion of Alpha ketoanalogue and these drugs.
• The susceptibility to cardioactive glycosides, and hence the risk for arrhythmia will increase in Alpha ketoanalogue.
• Monitoring of the serum phosphate levels is needed in case of concomitant administration of aluminum hydroxide.

Hypersensitivity to the active substances or to any of the excipients, Hypercalcemia, 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 Ketoalfa Acid Keto Analogues as well as the intake of any other calcium sources has to be reduced.

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.

• 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 Ketoalfa Acid Keto Analogues contains phenylalanine
• Monitoring of the serum phosphate levels is needed in case of concomitant administration of aluminium hydroxide

Other genito-urinary preparations

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