DOSAGE AND ADMINISTRATION
The total daily dose of the solution depends on the daily protein requirements and on the patient's metabolic and clinical response. In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, a solution containing 5% dextrose should be administered when hypertonic dextrose infusions are abruptly discontinued.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Peripheral Vein Nutritional Maintenance
Aminosyn 3.5% M*, Sulfite-Free, (a crystalline amino acid solution* with maintenance electrolytes) together with dextrose in concentrations of 5% to 10% is suitable for administration by peripheral vein. This solution is not intended for central vein infusion since it does not contain adequate amounts of amino acids or electrolytes appropriate for administration with high concentrations of dextrose.
For peripheral intravenous infusion, 1 to 1.5 g/kg/day of total amino acids will reduce protein catabolism. Infusion or ingestion of carbohydrate or lipid will not reduce the nitrogen sparing effect of intravenous amino acid infusions at this dose.
As with all intravenous fluid therapy, the primary aim is to provide sufficient water to compensate for insensible, urinary and other (nasogastric suction, fistula drainage, diarrhea) fluid losses. Total fluid requirements, as well as electrolyte and acid-base needs, should be estimated and appropriately administered.
For an amino acid solution of specified total concentration, the volume required to meet amino acid requirements per 24 hours can be calculated. After making an estimate of the total daily fluid (water) requirement, the balance of fluid needed beyond the volume of amino acid solution required can be provided either as a noncarbohydrate or a carbohydrate-containing electrolyte solution. I.V. lipid emulsion may be substituted for part of the carbohydrate-containing solution. Vitamins and additional electrolytes as needed for maintenance or to correct imbalances may be added to the amino acid solution.
A patient given the recommended maintenance fluid requirement of 35 mL/kg/day in the form of Aminosyn 3.5% M* will receive the average daily requirements for sodium, potassium, magnesium, phosphorus and chloride, along with an optimal amount of amino acids for preservation of nitrogen balance.
If desired, only one-half of an estimated daily amino acid requirement of 1.5 g/kg can be given on the first day. Amino acids together with dextrose in concentrations of 5% to 10% infused into a peripheral vein can be continued while oral nutrition is impaired. However, if a patient is unable to take oral nourishment for a prolonged period of time, institution of total parenteral nutrition with exogenous calories should be considered.
Central Vein Total Parenteral Nutrition
For central vein infusion with concentrated dextrose solution, alone or with I.V. lipid, the total daily dose of the amino acid solution depends upon daily protein requirements and the patient's metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements.
Admixtures of 3.5 to 4.25% amino acids with 5 to 10% glucose may be coinfused with a fat emulsion by peripheral vein to provide approximately 1400 to 2000 kcal/day. Fat emulsion coadministration should be considered when prolonged parenteral nutrition is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat-free total parenteral nutrition.
Aminosyn 7% or 8.5% WITH ELECTROLYTES should only be infused via a central vein when admixed with sufficient dextrose to provide full caloric requirements in patients who require prolonged total parenteral nutrition. I.V. lipid may be administered separately to provide part of the calories, if desired.
Total parenteral nutrition (TPN) may be started with 10% dextrose added to the calculated daily requirement of amino acids (1.5 g/kg for a metabolically stable patient). Dextrose content is gradually increased over the next few days to the estimated daily caloric need as the patient adapts to the increasing amounts of dextrose. Each gram of dextrose provides approximately 3.4 kcal. Each gram of fat provides 9 kcal.
The average depleted major surgical patient with complications requires between 2500 and 4000 kcal and between 12 and 24 grams of nitrogen per day. An adult patient in an acceptable weight range with restricted activity who is not hypermetabolic, requires about 30 kcal/kg of body weight/day. Average daily adult fluid requirements are between 2500 and 3000 mL and may be much higher with losses from fistula drainage or in severe burns. Typically, a hospitalized patient may lose 12 to 18 grams of nitrogen a day, and in severe trauma the daily loss may be 20 to 25 grams or more.
Aminosyn 7% and 8.5% WITH ELECTROLYTES are designed to supply necessary electrolytes to patients in a stable metabolic state (about three-fourths of all patients on total parenteral nutrition). Other patients may require more or less of the electrolytes present, e.g., cardiac patients who should not receive sodium. Aminosyn 7% and 8.5% WITH ELECTROLYTES do not contain calcium, and this should be added as indicated.
SERUM ELECTROLYTES SHOULD BE MONITORED AS INDICATED. Electrolytes may
be added to the nutrient solution as indicated by the patient's clinical condition
and laboratory determinations of plasma values. Major electrolytes are sodium,
chloride, potassium, phosphorus, magnesium and calcium. Vitamins, including
folic acid and vitamin K are required additives. The trace element supplements
should be given when long-term parenteral nutrition is undertaken.
Calcium and phosphorus are added to the solution as indicated. The usual dose
of phosphorus added to a liter of TPN solution (containing 25% dextrose) is
12 mM. This requirement is related to the carbohydrate calories delivered. Iron
is added to the solution or given intramuscularly in depot form as indicated.
Vitamin B12, vitamin K and folic acid are given intramuscularly or
added to the solution as desired.
Calcium and phosphorus additives are potentially incompatible when added to the TPN admixture. However, if one additive is added to the amino acid bottle, and the other to the bottle of concentrated dextrose, and if the contents of both bottles are swirled before they are combined, then the likelihood of physical incompatibility is reduced.
In patients with hyperchloremic or other metabolic acidosis, sodium and potassium may be added as the acetate or lactate salts to provide bicarbonate alternates.
In adults, hypertonic mixtures of amino acids and dextrose may be safely administered by continuous infusion through a central venous catheter with the tip located in the vena cava. Typically, the 7% or 8.5% solution is used in equal volume with 50% dextrose to provide an admixture containing 3.5% or 4.25% amino acids and 25% dextrose.
The rate of intravenous infusion initially should be 2 mL/min and may be increased gradually. If administration should fall behind schedule, no attempt to ''catch up'' to planned intake should be made. In addition to meeting protein needs, the rate of administration is governed by the patient's glucose tolerance estimated by glucose levels in blood and urine.
Aminosyn WITH ELECTROLYTES, when mixed with an appropriate volume of concentrated dextrose, offers a higher concentration of calories and nitrogen per unit volume. This solution is indicated for patients requiring larger amounts of nitrogen than could otherwise be provided or where total fluid load must be kept to a minimum, for example, patients with renal failure. Provision of adequate calories in the form of hypertonic dextrose may require exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, do not abruptly discontinue administration of nutritional solutions.
Aminosyn 7% or 8.5% WITH ELECTROLYTES may not be suitable for use in infants whose electrolyte requirements must be ''custom tailored'' based on serial blood chemistry determinations.
Pediatric requirements for parenteral nutrition are constrained by the greater relative fluid requirements of the infant and greater caloric requirements per kilogram. Amino acids are probably best administered in a 2.5% concentration. For most pediatric patients on intravenous nutrition,2.5 grams amino acids/kg/day with dextrose alone or with I.V. lipid calories of 100 to 130 kcal/kg/day is recommended. In cases of malnutrition or stress, these requirements may be increased. It is acceptable in pediatrics to start with a nutritional solution of half strength at a rate of about 60 to70 mL/kg/day. Within 24 to 48 hours the volume and concentration of the solution can be increased until the full strength pediatric solution (amino acids and dextrose) is given at a rate of 125 to 150 mL/kg/day.
Supplemental electrolytes and vitamin additives should be administered as deemed
necessary by careful monitoring of blood chemistries and nutritional status.
Addition of iron is more critical in the infant than the adult because of the
increasing red cell mass required for the growing infant. Serum lipids should
be monitored for evidence of essential fatty acid deficiency in patients maintained
on fat-free TPN. Bicarbonate should not be administered during infusion of the
nutritional solution unless deemed absolutely necessary.
To ensure the precise delivery of the small volumes of fluid necessary for total parenteral nutrition in infants, accurately calibrated and reliable infusion systems should be used.
A basic solution for pediatric use should contain 25 grams of amino acids and 200 to 250 grams of glucose per 1000 mL, administered from bottles containing 250 or 500 mL. Such a solution given at the rate of 145 mL/kg/day provides 130 kcal/kg/day.
WARNING: Do not use flexible container in series connections.
| List No.
|| Container (mL)
|| Aminosyn 3.5% M,* Sulfite-Free, (a crystalline amino acid solution* with
|| Aminosyn 7% WITH ELECTROLYTES, Sulfite-Free, (a crystalline amino acid
solution with electrolytes)
|| Aminosyn 8.5% WITH ELECTROLYTES, Sulfite-Free, (a crystalline amino acid
solution with electrolytes)
| *Contains maintenance electrolytes.
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive
heat. Protect from freezing. It is recommended that the product be stored at
room temperature (25° C). Avoid exposure to light.
Revised: September, 2004. Hospira, Inc., Lake Forest, IL 60045
USA. FDA Rev date: 3/9/2004