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Basic Drug Info
Drug Name:Aminosyn II with Electrolytes
Manufacturer:HOSPIRA, INC.
Other Info:

Central vein infusion (with added concentrated carbohydrate solutions) of amino acid solutions requires a knowledge of nutrition as well as clinical expertise in recognition and treatment of complications.

Attention must be given to solution preparation, administration and patient monitoring. IT IS ESSENTIAL THAT A CAREFULLY PREPARED PROTOCOL BASED ON CURRENT MEDICAL PRACTICES BE FOLLOWED, PREFERABLY BY AN EXPERIENCED TEAM.

SUMMARY HIGHLIGHTS OF COMPLICATIONS (consult current medical literature).Technical The placement of a central venous catheter should be regarded as a surgical procedure. One  should be fully acquainted with various techniques of catheter insertion. For details of technique  and placement sites, consult the medical literature. X-ray is the best means of verifying catheter  placement.

Complications known to occur from the placement of central venous catheters are  pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formation of arteriovenous fistula, phlebitis, thrombosis and  air and catheter emboli.Septic The constant risk of sepsis is present during administration of total parenteral nutrition.

It is  imperative that the preparation of the solution and the placement and care of catheters be  accomplished under strict aseptic conditions.Solutions should ideally be prepared in the hospital pharmacy under a laminar flow hood using  careful aseptic technique to avoid inadvertent touch contamination.

Solutions should be used promptly after mixing.

Storage should be under refrigeration and limited to a brief period of  time, preferably less than 24 hours.Administration time for a single container and set should never exceed 24 hours.Metabolic The following metabolic complications have been reported with TPN administration: metabolic  acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, hyperglycemia,  hyperosmolar nonketotic states and dehydration, glycosuria, rebound hypoglycemia, osmotic  diuresis and dehydration, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte  imbalances and hyperammonemia in children.

Frequent evaluations are necessary especially  during the first few days of therapy to prevent or minimize these complications.Administration of glucose at a rate exceeding the patient’s utilization rate may lead to  hyperglycemia, coma and death.



Clinical Trials:


Indications and Usage

Aminosyn II 8.5% WITH ELECTROLYTES, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion is indicated as a source of nitrogen in the nutritional support of patients in whom, for short periods of time, oral nutrition cannot be tolerated, is undesirable, or inadequate.Aminosyn II 8.5% WITH ELECTROLYTES can be administered peripherally with dilute (5 to 10%) dextrose solution and I.V.

fat emulsion as a source of nutritional support.

This form of nutritional support can help to preserve protein and reduce catabolism in stress conditions where oral intake is inadequate.When administered with concentrated dextrose solution with or without fat emulsions, Aminosyn II 8.5% WITH ELECTROLYTES is also indicated for central vein infusion to prevent or reverse negative nitrogen balance in patients where: (a) the alimentary tract, by the oral, gastrostomy or jejunostomy route cannot or should not be used; (b) gastrointestinal absorption of protein is impaired; (c) metabolic requirements for protein are substantially increased as with extensive burns and (d) morbidity and mortality may be reduced by replacing amino acids lost from tissue breakdown, thereby preserving tissue reserves, as in acute renal failure.
Kidney Failure, Acute -- A severe stage of acute renal insufficiency, characterized by the sudden decrease in GLOMERULAR FILTRATION RATE to less than 15 ml per min, sometime to less than 1 to 2 ml per min. It is usually associated with OLIGURIA; EDEMA; and increase in BLOOD UREA NITROGEN and serum CREATININE concentrations.

Contraindications
This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.
Hepatic Coma --

Unspecified disorder of metabolism -- Generic term for diseases caused by an abnormal metabolic process. It can be congenital due to inherited enzyme abnormality (METABOLISM, INBORN ERRORS) or acquired due to disease of an endocrine organ or failure of a metabolically important organ such as the liver. (Stedman, 26th ed)

Warnings

Intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN), especially in patients with impaired hepatic or renal function.

Appropriate laboratory tests should be performed periodically and infusion discontinued if BUN levels exceed normal postprandial limitsand continue to rise.

It should be noted that a modest rise in BUN normally occurs as a result of increased protein intake.Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma.Administration of amino acid solutions in the presence of impaired renal function may augment an increasing BUN, as does any protein dietary component.Solutions containing sodium ion should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.Solutions which contain potassium ion should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis.

Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.Aminosyn II 8.5% WITH ELECTROLYTES, Sulfite-Free, (an amino acid injection) may not be suitable for use in infants who require individualized electrolyte therapy.Hyperammonemia is of special significance in infants, as it can result in mental retardation. Therefore, it is essential that blood ammonia levels be measured frequently in infants.Instances of asymptomatic hyperammonemia have been reported in patients without overt liver dysfunction.

The mechanisms of this reaction are not clearly defined, but may involve genetic defects and immature or subclinically impaired liver function. WARNING: This product contains aluminum that may be toxic.

Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired.

Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.

Tissue loading may occur at even lower rates of administration.

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