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 supplements.
Strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.
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.
Peripheral intravenous administration of HepatAmine® (amino acid) (8% Amino Acid Injection) requires appropriate dilution and provision of adequate calories. Care should be taken to assure proper placement of the needle 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.
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.
Infusion of HepatAmine (amino acid) may not affect the clinical course of patients with fulminant hepatitis who have a poor prognosis and are generally unresponsive to treatment. It has been shown that the abnormal plasma amino acid pattern in fulminant hepatitis differs from that in chronic liver disease.
Extraordinary electrolyte losses such as may occur during protracted nasogastric suction, vomiting, diarrhea, or gastrointestinal fistula drainage may necessitate additional electrolyte supplementation.
Administration of glucose at a rate exceeding the patient's utilization rate may lead to hyperglycemia, coma, and death.
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.
HepatAmine (amino acid) contains less than 3 mEq chloride per liter.
HepatAmine (amino acid) contains 10 mmole/liter of phosphate. Some 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.
HepatAmine (amino acid) has not been adequately studied in pregnant women and pediatric patients; therefore, its safe use in such patients has not been demonstrated.
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 HepatAmine (amino acid) only if solution is clear, the seal unbroken, and vacuum is present.
Drug product contains no more than 25 Âµg/L of aluminum.
Frequent clinical evaluation and laboratory determinations are necessary
for proper monitoring during administration.
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 HepatAmine® (8% Amino Acid Injection).
Pregnancy - Teratogenic Effects - Pregnancy Category C.
Pregnancy Category C. Animal reproduction studies have not been conducted
with HepatAmine (8% Amino Acid Injection). It is also not known whether HepatAmine (amino acid)
can cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. HepatAmine (amino acid) 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 HepatAmine (amino acid) is administered to a nursing woman.
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 WARNINGS and DOSAGE
Clinical studies of HepatAmine (amino acid) did not include sufficient numbers of subjects age 65 years 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 is beyond the scope of this insert, the following summary lists those based on current 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 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 arterio-venous fistula, phlebitis,
thrombosis, pericardial tamponade, and air and catheter embolus.
Septic. The constant risk of sepsis is present during total parenteral
nutrition. Since contaminated solutions and infusion catheters are potential
sources of infection, it is imperative that the preparation of solutions and
the placement and care of catheters be accomplished under controlled aseptic
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.
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 24 hours.
Consult the medical literature for a discussion of the management of sepsis. In brief, typical management includes replacing the solution being administered with a fresh container and set, and culturing the contents 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.
Metabolic. The following metabolic complications have been reported
during the use of central venous nutrition; metabolic acidosis, hypophosphatemia,
alkalosis, hyperglycemia and glycosuria, osmotic diuresis and dehydration, rebound
hypoglycemia, elevated liver enzymes, hypo- and hyper-vitaminosis, electrolyte
imbalances and hyperammonemia in pediatric patients. Frequent clinical evaluation
and laboratory determinations are necessary, especially during the first few
days of therapy to prevent or minimize these complications.