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Aminosyn II 4.25

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Aminosyn II 4.25% in 25% Dextrose

INDICATIONS

Aminosyn II 4.25% in 25% Dextrose Injection is indicated for central vein infusion in the prevention of nitrogen loss and negative nitrogen balance in cases where (a) the gastrointestinal tract by the oral, gastrostomy or jejunostomy route cannot or should not be used, (b) gastrointestinal absorption of nutrients is impaired or (c) metabolic requirements for protein and calories 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. In such patients intravenous feeding for more than a few days would be expected.

The addition of supplemental electrolytes will be required in accordance with the prescription of the attending physician.

DOSAGE AND ADMINISTRATION

The total daily dose of Aminosyn II 4.25% in 25% Dextrose Injection to be infused depends on daily protein and caloric 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.

As reported in the literature, the dosage and constant infusion rate of intravenous dextrose must be selected with caution in pediatric patients, particularly neonates and low birth weight infants, because of the increased risk of hyperglycemia/ hypoglycemia.

As with all intravenous fluid therapy, the parenteral administration of a solution of amino acids and dextrose requires an accurate estimate of the total fluid and electrolytes needed to compensate for the patient's measurable urinary and other (i.e., nasogastric suction, fistula drainage, diarrhea) daily losses. After estimating the total daily fluid (water) requirements, the appropriate volume to be infused to meet the daily protein requirement of the patient, can be determined. The balance of fluid needed beyond the volume of the amino acid/dextrose solution can be provided by other solutions suitable for intravenous infusion. Lipid emulsion can be administered to provide up to 3 g fat/kg/day, infused simultaneously with Aminosyn II 4.25% in 25% Dextrose Injection by means of a Y-connector located near the infusion site, using separate flow controls for each solution. Aminosyn II 4.25% in 25% Dextrose Injection should not be premixed with fat emulsion. Vitamins and trace minerals may be added to the amino acid/dextrose solution as needed.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

The total daily dose of the amino acid/dextrose solution to be infused depends on daily protein requirements and on the patient's metabolic and clinical response. The daily determination of nitrogen balance and accurate body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements.

Adults

The daily nutrient requirements of an average adult patient, not hypermetabolic, in an acceptable weight range and with restricted physical activity, are about 30 kcal/kg of body weight, 12 to 18 grams of nitrogen and between 2500 and 3000 mL of fluids. In depleted and severely traumatized patients such as burned patients or patients who have received major surgery with complications, the requirements for nutrients and fluids may be significantly higher. In such cases, 4000 calories and 25 grams of nitrogen or more may be required daily to achieve nitrogen balance. The fluid losses through drainages and wound surface must be taken into account in calculating the fluid requirements of these patients.

Fat emulsion administration 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 TPN.

Each gram of dextrose provides approximately 3.4 calories — 1000 mL of Aminosyn II 4.25% in 25% Dextrose Injection will provide 6.5 grams of nitrogen and 850 calories. The infusion rate of Aminosyn II 4.25% in 25% Dextrose Injection should be 2 mL/min initially and may be gradually increased to deliver the required amounts of amino acids and calories. If nutrient administration falls behind schedule, under no circumstances should an attempt to “catch up” to planned intake be made. The rate of nutrient infusion is governed by the protein requirements and by the patient's glucose tolerance estimated by glucose levels in plasma and urine. The maximum rate at which dextrose can be infused without producing glycosuria is 0.5 g/kg/hour; at a rate of 0.8 g/kg/hour, about 95% of the infused dextrose is retained. Administration of exogenous insulin may be required in order to control hyperglycemia and glycosuria which may occur upon infusion of concentrated glucose solutions. When concentrated dextrose infusion is abruptly interrupted rebound hypoglycemia may occur, which can be prevented by the administration of 5% or 10% dextrose solutions. Part of the caloric requirements may be met by the infusion of I.V. fat emulsions.

SERUM ELECTROLYTES SHOULD BE MONITORED AS INDICATED.

Electrolytes should 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, phosphate, magnesium and calcium. Adding 20 mL of TPN Electrolytes (List 5779) to the amino acid chamber and 5 mL of Potassium Phosphate (List 7296) to the dextrose chamber will result in final admixture concentrations (in mEq/L) as follows: 54 sodium, 42 potassium, 35 chloride, 5 magnesium, 4.5 calcium, 60.1 acetate, and 15 (mM) phosphate. Alternate electrolyte additives may be used at the clinician's discretion.

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 phosphate 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 phosphate additives are potentially incompatible when added to the TPN admixture. However, if one additive is added to the amino acid solution, and the other to the concentrated dextrose solution, and if the contents of both chambers are mixed 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.

Pediatric

Pediatric requirements for parenteral nutrition are constrained by the greater relative fluid requirements of the infant and greater caloric requirements per kilogram. A 4.25% amino acid solution is too concentrated for use in pediatric patients less than one year old, who generally receive a 2.5% amino acid solution. However, older pediatric patients can receive Aminosyn II 4.25% in 25% Dextrose Injection. The suggested amino acid dosage level for children between 4 and 12 years of age is 2 g/kg/day; for 13 to 15 years of age, 1.7 g/kg/day; and for 16 years of age and above, 1.5 g/kg/day. Energy requirements for children between 1 and 7 years of age are approximately 75 to 90 kcal/kg/day; for children 7 to 12 years of age, 60 to 75 kcal/kg/day; and for ages 12 to 18 years, 30 to 60 kcal/kg/day. Energy intake may be supplemented with intravenous fat emulsion. In cases of malnutrition or stress, these requirements may be increased.

Supplemental electrolytes and vitamin additives should be administered as deemed necessary by careful monitoring of blood chemistries and nutritional status. Iron supplementation is more critical in the child than the adult because of the increasing red cell mass required by the growing child. 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 children, accurately calibrated and reliable infusion systems should be used.

Instructions for Use

DO NOT USE IF AMINOSYN II IS DISCOLORED OR IF CLAMP IS OPEN OR MISSING. COLOR VARIATION IN THE DEXTROSE INJECTION FROM PALE YELLOW TO YELLOW IS NORMAL AND DOES NOT ALTER EFFICACY.

To Open

Tear outer wrap at notch. After removing the overwrap, check for minute leaks by squeezing the container firmly. If leaks are found, discard solution as sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration.

To Add Medication
  1. Prepare the appropriate additive port.
  2. Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area through inner diaphragm and inject. Withdraw needle after injecting medication.
  3. The additive ports should be protected by covering with additive caps.
  4. Mix container contents thoroughly.
Preparation for Administration

(Use aseptic technique)

  1. Open clamp between the two chambers. Completely drain all the solution and air into the lower chamber. To achieve this, stretch the side wall of the emptied top chamber.
  2. Close flow control clamp of administration set.
  3. Remove cover from outlet port at bottom of container.
  4. Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton.
  5. Suspend from hanger at top of container.
  6. Squeeze and release drip chamber to establish proper fluid level in chamber.
  7. Open flow control clamp to expel air from set. Close flow control clamp.
  8. Connect to central infusion catheter.
  9. Regulate rate of administration with flow control clamp. Ensure that all solution and air are in the lower chamber when reading fluid levels.

WARNING: Do not use flexible container in series connections.

HOW SUPPLIED

Aminosyn® II 4.25% in 25% Dextrose Injection is supplied in a 1000 mL volume dual-chamber flexible container (List No. 7702). Aminosyn II 4.25% in 25% Dextrose Injection is obtained by opening the clamp separating the two chambers and mixing the contents of the upper chamber, 500 mL of Aminosyn II 8.5% and the lower chamber, 500 mL of 50% Dextrose Injection, USP.

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); however, brief exposure up to 40°C does not adversely affect the product.

Avoid exposure to light.

To prevent breakage, handle cold or refrigerated (2°C to 8°C) co-polyester (CR3) containers with care.

Hospira, Inc., Lake Forest, IL 60045 USA. Revised: May, 2004. FDA revision date: 2/19/2003

Last reviewed on RxList: 1/14/2009
This monograph has been modified to include the generic and brand name in many instances.

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