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P.T. Ikapharmindo Putramas
[Natrapharm]
Regulatory Class: Rx
C: Ketoanalogues + essential amino acids: Ca-3-methyl-2-oxo-valerate (α-ketoanalogue to isoleucine, Ca salt) 67 mg, Ca-4-methyl-2-oxo-valerate (α-ketoanalogue to leucine, Ca salt) 101 mg, Ca-2-oxo-3-phenylpropionate (α-ketoanalogue to phenylalanine, Ca salt) 68 mg, Ca-3-methyl-2-oxo-butyrate (α-ketoanalogue to valine, Ca salt) 86 mg, Ca-DL-2-hydroxy-4-(methylthio) butyrate (α-hydroxyanalogue to methionine, Ca salt) 59 mg, L-lysine acetate (equiv to 75 mg L-lysine) 105 mg, L-threonine 53 mg, L-tryptophan 23 mg, L-histidine 38 mg, L-tyrosine 30 mg. Total nitrogen content/tab: 36 mg, Ca/tab: 1.25 mmol equiv to 0.05 g
I: Prevention & therapy of damage due to faulty or deficient protein metabolism in chronic renal insufficiency in connection w/ limited protein in food of ≤40 g/day & in patients w/ GFR <25 mL/min.
D: Adult >70 kg 4-8 tab tid.
CI: Hypersensitivity to ≥1 amino acids or idiosyncratic reaction to ketoanalogues of essential amino acids. Metabolic disorders associated w/ impaired nitrogen utilization; hypercalcemia, disturbed amino acid metabolism. Renal failure, severe liver diseases & hepatic coma.
SP: Patients w/ severe heart disease. Ensure sufficient supply of calories. Regular evaluation of serum Ca level & laboratory determinations. Chronic renal disease. Parenteral regimens should include non-protein calories adequate for wt maintenance if patient requires extended period of nutritional support.
AR: Hypercalcemia; generalized flushing, fever, nausea. Vomiting, abdominal pain, diarrhea & fatigue may occur at the beginning of therapy.
INT: Increase of serum Ca level or intensification w/ Ca-containing medicaments. Interfered absorption w/ sparingly soluble compd w/ Ca (eg, tetracycline).