n.
Phosphate is a major intracellular anion which participates in providing energy for metabolism ofsubstrates and contributes to significant metabolic and enzymatic reactions in all organs and tissues.
Itexerts a modifying influence on calcium levels, a buffering effect on acid-base equilibrium and has aprimary role in the renal excretion of hydrogen ions.
It is thought that the acetate from lysine acetate and acetic acid, under the condition of parenteralnutrition, does not impact net acid-base balance when renal and respiratory functions are normal. Clinicalevidence seems to support this thinking; however, confirmatory experimental evidence is not available.
The amounts of sodium and chloride present are not of clinical significance.
INDICATIONS AND USAGE
Parenteral nutrition with 10% FreAmine® III (Amino Acid Injection) is indicated to prevent nitrogenloss or treat negative nitrogen balance in adults and pediatric patients where (1) the alimentary tract, bythe oral, gastrostomy, or jejunostomy route, cannot or should not be used, or adequate protein intake is
not feasible by these routes; (2) gastrointestinal absorption of protein is impaired; or (3) proteinrequirements are substantially increased as with extensive burns. Dosage, route of administration, andconcomitant infusion of nonprotein calories are dependent on various factors, such as nutritional andmetabolic status of the patient, anticipated duration of parenteral nutritional support, and vein tolerance.
See WARNINGS, PRECAUTIONS, Pediatric Use, and DOSAGE AND ADMINISTRATION.
Central Venous Nutrition
Central venous infusion should be considered when amino acid solutions are to be admixed with
hypertonic dextrose to promote protein synthesis in hypercatabolic or severely depleted patients, orthose requiring long-term parenteral nutrition.
Peripheral Parenteral Nutrition
For moderately catabolic or depleted patients in whom the central venous route is not indicated, dilutedamino acid solutions mixed with 5% dextrose solutions may be infused by peripheral vein,supplemented, if desired, with fat emulsion. In pediatric patients, the final solution should not exceedtwice normal serum osmolarity (718 mOsmol/L).
Protein Sparing
In well-nourished, mildly catabolic patients such as routine postsurgical patients who require onlyshort-term parenteral nutrition, protein sparing can be achieved by peripheral infusion of amino acidsolutions with or without dextrose.
CONTRAINDICATIONS
10% FreAmine® III is contraindicated in patients with anuria, hepatic coma, inborn errors of amino acidmetabolism, or hypersensitivity to one or more amino acids present in the solution.
WARNINGS
This product contains sodium bisulfite, a sulfite that may cause allergic-type reactions includinganaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptiblepeople. The overall preva lence of sulfite sensitivity in the general population is unknown and probablylow. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels withprolonged parenteral administration if kidney function is impaired. Premature neonates are particularly atrisk because their kidneys are immature, and they require large amounts of calcium and phosphatesolutions, which contain alumin |