Aminosyn-HBC

Flexible Plastic Container

Rx only

Aminosyn-HBC 7%, Sulfite-Free, (an amino acid injection high branched chain) provides a mixture of biologically utilizable essential and nonessential crystalline amino acids in concentrated form for protein synthesis. The solution contains a high (45%) concentration of the branched chain amino acids (isoleucine, leucine and valine) relative to other general purpose amino acid injections. Aminosyn-HBC 7%, when mixed with a concentrated source of calories such as hypertonic dextrose, supplemented with appropriate electrolytes, vitamins and trace metals and infused by central vein with or without fat emulsion, provides total parenteral nutrition (TPN) for the severely compromised patient.

Aminosyn-HBC 7% may also be administered peripherally with minimal caloric supplementation in order to conserve lean body mass in the well-nourished, mildly catabolic patient.

A high concentration of the branched chain amino acids is present in Aminosyn-HBC 7% because these amino acids have been reported to be metabolically active in the compromised patient.

The acetate content of the solution, under conditions of parenteral nutrition, would not be expected to affect acid-base status adversely when renal and respiratory functions are normal; confirmatory clinical/experimental evidence is not available. The amount of sodium present is not clinically significant. The concentration of chloride present is typical for TPN regimens.

Parenteral nutrition with Aminosyn-HBC 7%, Sulfite-Free, (an amino acid injection high branched chain) is indicated to prevent nitrogen loss or treat negative nitrogen balance in adults where (1) the alimentary tract, by the 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) nitrogen homeostasis is substantially impaired as with severe trauma or sepsis. Dosage, route of administration and concomitant infusion of nonprotein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutrition support, and vein tolerance. See DOSAGE AND ADMINISTRATION for additional information.

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, or those requiring long-term parenteral nutrition. See SPECIAL PRECAUTIONS FOR CENTRAL INFUSIONS.

Peripheral Parenteral Nutrition: For moderately catabolic or depleted patients in whom the central venous route is not indicated, diluted amino acid solutions with minimal caloric supplementation may be infused by peripheral vein, supplemented, if desired, with fat emulsion.

Aminosyn-HBC 7%, Sulfite-Free, (an amino acid injection high branched chain) is contraindicated in patients with anuria, hepatic coma, inborn errors of amino acid metabolism (especially those involving branched chain amino acid metabolism such as Maple Syrup Urine Disease and Isovaleric Acidemia), severe or uncorrected electrolyte or acid-base imbalance, hyperammonemia or other disorders involving impaired nitrogen utilization, or hypersensitivity to one or more amino acids present in the solution.

Special care must be taken when administering hypertonic glucose to provide calories in diabetic or prediabetic patients.

Do not withdraw venous blood for blood chemistries through the peripheral infusion site, as interference with estimations of nitrogen-containing substances may occur.

Intravenously administered amino acids should be used with caution in patients with history of renal disease, pulmonary disease, or with cardiac insufficiency so as to avoid excessive fluid accumulation.

The effect of infusion of amino acids, without dextrose, upon carbohydrate metabolism of children is not known at this time.

Nitrogen intake should be carefully monitored in patients with impaired renal function.

Aminosyn-HBC 7%, Sulfite -Free, (an amino acid injection high branched chain) contains no added phosphorus. Patients, especially those with hypophosphatemia, may require the addition of phosphate. To prevent hypocalcemia, calcium supplementation should always accompany phosphate administration. To assure adequate intake, serum levels should be monitored frequently.

For long-term total nutrition, or if a patient has inadequate fat stores, it is essential to provide adequate exogenous calories concurrently with the amino acids. Concentrated dextrose solutions are an effective source of such calories. Such strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.

Aminosyn-HBC contains no more than 25 mcg/L of aluminum.

SPECIAL PRECAUTIONS FOR

CENTRAL INFUSIONS

ADMINISTRATION BY CENTRAL VENOUS CATHETER SHOULD BE USED ONLY

BY THOSE FAMILIAR WITH THIS TECHNIQUE AND ITS COMPLICATIONS.

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 (See also Current Medical Literature).

1. 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.

2. 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 bottle and set should never exceed 24 hours.

3. Metabolic

   The following metabolic complications have been reported with TPN administration: Metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, hyperglycemia, and 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.

Pregnancy:

Teratogenic effects.

Pregnancy Category C: Animal reproduction studies have not been performed with Aminosyn-HBC 7%. It is not known whether Aminosyn-HBC 7% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminosyn-HBC 7% should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Safety and effectiveness in children have not been established.

Geriatric Use:

Clinical studies of Aminosyn-HBC 7% did not include sufficient numbers of subjects aged 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 dosage range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Drug Interactions

Because of its antianabolic activity, concurrent administration of tetracycline may reduce the potential anabolic effects of amino acids infused with dextrose as part of a parenteral feeding regimen.

Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

In the event of fluid, electrolyte or metabolic imbalances re-evaluate the patient and institute appropriate corrective measures; see WARNINGS and PRECAUTIONS.