Clinical evaluation and periodic laboratory
determinations are necessary to monitor changes in fluid balance, electrolyte
concentrations, and acid-base balance during prolonged parenteral therapy or whenever
the condition of the patient warrants such evaluation. Significant deviations
from normal concentrations may require the use of additional electrolyte
Strongly hypertonic nutrient solutions should be
administered through an indwelling intravenous catheter with the tip located in
the superior vena cava.
Care should be taken to avoid circulatory overload,
particularly in patients with cardiac insufficiency.
In patients with myocardial infarct, infusion of amino
acids should always be accompanied by dextrose, since in anoxia, free fatty
acids cannot be utilized by the myocardium, and energy must be produced anaerobically
from glycogen or glucose.
Special care must be taken when giving hypertonic
dextrose to a diabetic or prediabetic patient. To prevent severe hyperglycemia
in such patients, insulin may be required.
Administration of glucose at a rate exceeding the
patient's utilization may lead to hyperglycemia, coma, and death.
Administration of amino acids without carbohydrates may
result in the accumulation of ketone bodies in the blood. Correction of this
ketonemia may be achieved by the administration of carbohydrate.
After appropriate dilution, if 10% FreAmine® III (Amino
Acid Injection) is to be administered by peripheral vein, care should be taken
to assure proper placement of the infusion device within the lumen of the vein.
The venipuncture site should be inspected frequently for signs of infiltration.
If venous thrombosis or phlebitis occurs, discontinue
infusions or change infusion site and initiate appropriate treatment.
Extraordinary electrolyte losses such as may occur during
protracted nasogastric suction, vomiting, diarrhea or gastrointestinal fistula
drainage may necessitate additional electrolyte supplementation.
Metabolic acidosis can be prevented or readily controlled
by adding a portion of the cations in the electrolyte mixture as acetate salts
and in the case of hyperchloremic acidosis, by keeping the total chloride
content of the infusate to a minimum. 10% FreAmine® III contains less than 3
mEq chloride per liter.
10% FreAmine® III contains phosphorus. Patients,
especially those with hypophosphatemia, may require additional phosphate. To
prevent hypocalcemia, calcium supplementation should always accompany phosphate
administration. To assure adequate intake, serum levels should be monitored frequently.
To minimize the risk of possible incompatibilities
arising from mixing this solution with other additives that may be prescribed,
the final infusate should be inspected for cloudiness or precipitation immediately
after mixing, prior to administration, and periodically during administration.
Use only if solution is clear and vacuum is present.
Drug product contains no more than 25 μg/L of
Frequent clinical evaluation and laboratory
determinations are necessary for proper monitoring of central venous nutrition.
Laboratory tests should include measurement of blood
sugar, electrolyte, and serum protein concentrations; kidney and liver function
tests; and evaluation of acid-base balance and fluid balance. Other laboratory
tests may be suggested by the patient's condition.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
No in vitro or in vivo carcinogenesis, mutagenesis, or
fertility studies have been conducted with 10% FreAmine® III (Amino Acid
Pregnancy Category C
Animal reproduction studies have not been conducted with
10% FreAmine® III (Amino Acid Injection). It is also not known whether 10%
FreAmine® III can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. 10% FreAmine® III should be given to a pregnant
woman only if clearly needed.
Labor And Delivery
Information is unknown.
It is not known whether this drug is excreted in human
milk. Because many drugs are excreted in human milk, caution should be
exercised when 10% FreAmine® III (Amino Acid Injection) is administered to a nursing
Safety and effectiveness of amino acid injections in
pediatric patients have not been established by adequate and well-controlled
studies. However, the use of amino acid injections in pediatric patients as an
adjunct in the offsetting of nitrogen loss or in the treatment of negative
nitrogen balance is well established in the medical literature. See INDICATIONS AND USAGE, WARNINGS, and DOSAGE AND ADMINISTRATION.
Clinical studies of 10% FreAmine® III (Amino Acid
Injection) did not include sufficient numbers of subjects age 65 and over to
determine whether they respond differently from younger subjects. Other reported
clinical experience has not identified differences in responses between the
elderly and younger patients. In general, dose selection for an elderly patient
should be cautious, usually starting at the low end of the dosing range,
reflecting the greater frequency of decreased hepatic, renal, or cardiac function,
and of concomitant disease or other drug therapy.
This drug is known to be substantially excreted by the
kidney, and the risk of toxic reactions to this drug may be greater in patients
with impaired renal function. Because elderly patients are more likely to have decreased
renal function, care should be taken in dose selection, and it may be useful to
monitor renal function. See WARNINGS.
Special Precautions For Central Venous Nutrition
Administration by central venous catheter should be used
only by those familiar with this technique and its complications .
Central venous nutrition may be associated with
complications which can be prevented or minimized by careful attention to all
aspects of the procedure including 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.
Although a detailed discussion of the complications of
central venous nutrition is beyond the scope of this insert, the following
summary lists those based on current literature:
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 as well as recognition and treatment of complications.
For details of techniques 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 embolus.
The constant risk of sepsis is present during central
venous nutrition. Since contaminated solutions and infusion catheters are
potential sources of infection, it is imperative that the preparation of
parenteral nutrition solutions and the placement and care of catheters be
accomplished under controlled aseptic conditions.
Solutions should ideally be prepared in the hospital
pharmacy in a laminar flow hood. The key factor in their preparation is careful
aseptic technique to avoid inadvertent touch contamination during mixing of solutions
and subsequent admixtures.
Parenteral nutrition solutions should be used promptly
after mixing. Any storage should be under refrigeration for as brief a time as
possible. Administration time for a single bottle and set should never exceed
Consult the medical literature for a discussion of the
management of sepsis during central venous nutrition. In brief, typical
management includes replacing the solution being administered with a fresh container
and set, and the remaining contents are cultured for bacterial or fungal
contamination. If sepsis persists and another source of infection is not
identified, the catheter is removed, the proximal tip cultured, and a new
catheter reinserted when the fever has subsided. Non-specific, prophylactic antibiotic
treatment is not recommended. Clinical experience indicates that the catheter
is likely to be the prime source of infection as opposed to aseptically
prepared and properly stored solutions.
The following metabolic complications have been reported:
metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia and glycosuria,
osmotic diuresis and dehydration, rebound hypoglycemia, elevated liver enzymes,
hypo- and hypervitaminosis, electrolyte imbalances, and hyperammonemia in pediatric
patients. Frequent clinical evaluation and laboratory determinations are
necessary, especially during the first few days of central venous nutrition, to
prevent or minimize these complications.