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Aminosyn II 3.5

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Aminosyn II 3.5% in 5% Dextrose

INDICATIONS

Aminosyn II 3.5% in 5% Dextrose (amino acid injection in dextrose injection) Injection infused through a peripheral vein is indicated as a source of nitrogen in the nutritional support of patients in whom for short periods of time oral nutrition cannot be tolerated, is undesirable or inadequate.

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 3.5% in 5% Dextrose (amino acid injection in dextrose injection) Injection to be infused depends on the daily protein requirements and on the patient's metabolic and clinical response.

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 II 3.5% in 5% Dextrose (amino acid injection in dextrose injection) Injection is suitable for administration by peripheral vein. The solution is not intended for central vein infusion since it does not contain adequate amounts of amino acids or electrolytes 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 fluid losses (nasogastric suction, fistula drainage, and diarrhea). Aminosyn II 3.5% in 5% Dextrose (amino acid injection in dextrose injection) infused at a rate of 45 mL/kg/day, will meet the fluid and amino acid requirements of the stable adult patient.

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.

The daily requirements of the stable, nonhypermetabolic adult patient in an acceptable weight range with restricted physical activity are approximately 30 kcal/kg of body weight, 1 to 1.5 g amino acid/kg, and 2500 to 3000 mL of fluids. Each gram of infused dextrose provides 3.4 kcal; each gram of infused fat provides 9 kcal. A 10% lipid emulsion contains 1.1 kcal/mL. Lipid emulsion can be administered to provide up to 3 g fat/kg/day, infused simultaneously with Aminosyn II 3.5% in 5% Dextrose (amino acid injection in dextrose injection) Injection by means of a Y-connector located near the infusion site, using separate flow controls for each solution. Aminosyn II 3.5% in 5% Dextrose Injection should not be premixed with fat emulsion. If it is anticipated that re-institution of oral feedings cannot occur for a prolonged period of time, consideration should be given to starting a central venous feeding regimen.

Electrolytes and vitamins must be added to the solution, per the physician's prescription, to meet individual patient requirements.

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, phosphate, 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.

Pediatric

Pediatric requirements for parenteral nutrition are constrained by the greater relative fluid requirements of the infant and greater caloric requirements per kilogram. A 3.5% amino acid solution is too concentrated for use in pediatric patients less than 1 year old, who generally require a 2.5% amino acid solution. However, older pediatric patients can receive Aminosyn II 3.5% in 5% Dextrose (amino acid injection in dextrose injection) 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 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 3.5% (amino acid injection in dextrose injection) in 5% Dextrose Injection is supplied in a 1000 mL volume dual-chamber flexible container (List No. 7701). Aminosyn II 3.5% in 5% Dextrose (amino acid injection in dextrose injection) Injection is obtained by opening the clamp separating the two chambers and mixing the contents of the upper chamber, 500 mL of Aminosyn II 7% and the lower chamber, 500 mL of 10% 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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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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