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Aminosyn RF 5.2

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Aminosyn RF 5.2% Sulfite Free

Warnings
Precautions

WARNINGS

Intravenous infusion of amino acids may induce a rise in blood urea nitrogen (BUN), especially in patients with impaired hepatic or renal function. Appropriate laboratory tests should be performed periodically and infusion discontinued or nitrogen content reduced if BUN levels continue to rise inappropriately.

Administration of nitrogen in any form to patients with marked hepatic insufficiency may result in serum amino acid imbalances or CNS complications. Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula), therefore, should be used with caution in such patients.

Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis.

Hyperammonemia is of special significance in infants, as it can result in mental retardation. Therefore, it is essential that blood ammonia levels be measured frequently in infants.

Aminosyn-RF 5.2% does not replace dialysis and conventional supportive therapy in patients with renal failure.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

CLINICAL EVALUATIONS AND LABORATORY DETERMINATIONS, AT THE DISCRETION OF THE ATTENDING PHYSICIAN, ARE NECESSARY FOR PROPER MONITORING DURING ADMINISTRATION. Blood studies should include glucose, urea nitrogen, serum electrolytes, acid-base balance, blood ammonia levels, serum proteins, kidney and liver function tests, serum osmolality and hemogram. Circulating blood volume should be determined if indicated. If sepsis is suspected, blood cultures should be taken.

Clinically significant hypocalcemia, hypophosphatemia or hypomagnesemia may occur as a result of therapy with Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) and hypertonic dextrose; electrolyte replacement may become necessary.

In order to promote urea nitrogen reutilization in patients with renal failure, it is essential to provide adequate calories with minimal amounts of the essential amino acids and to restrict the intake of nonessential nitrogen. Hypertonic dextrose solutions are a convenient and metabolically effective source of concentrated calories. Special care must be taken when giving hypertonic glucose to provide calories in diabetic or prediabetic patients. Hypertonic solutions should be administered through an indwelling catheter with the tip located in the superior vena cava. When abrupt cessation of hypertonic dextrose is required, monitoring for rebound hypoglycemia should be instituted. Essential fatty acid deficiency (EFAD) is becoming increasingly recognized in patients on long term TPN (more than 5 days). The use of fat emulsion to provide 4–10% of total caloric intake as linoleic acid may prevent EFAD.

Fluid balance should be carefully monitored in patients with renal failure to avoid excessive fluid overload, especially in relation to cardiac insufficiency.

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 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

(Also see Current Medical Literature)

1. Technical

The placement of a central venous catheter should be regarded as a surgical procedure. 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 risk of sepsis is present constantly 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.

3. Metabolic

A wide variety of metabolic complications can occur during total parenteral nutrition and frequent evaluations are necessary, especially during the first few days of administration.

Pregnancy Category C

Animal reproduction studies have not been conducted with Aminosyn-RF 5.2%. It is also not known whether Aminosyn-RF 5.2% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminosyn-RF 5.2% should be given to a pregnant woman only if clearly needed.

Geriatric Use

Clinical studies of Aminosyn-RF have not been performed to determine whether patients over 65 years respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for elderly patients should be cautious, 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 adverse 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 functions.

Aminosyn 5.2% contains no more than 25 mcg/L of aluminum.

Special Precautions In Patients With Renal Insufficiency

Frequent laboratory studies are necessary in patients with renal insufficiency. In renal failure hyperglycemia may not be reflected by glycosuria. Blood glucose must be determined frequently, often every six hours to guide dosage of dextrose, and insulin should be given, if required.

Special Precautions In Pediatric Patients

Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) should be used with special caution in pediatric patients with acute renal failure, especially low birth weight infants. Laboratory and clinical monitoring of pediatric patients, especially those who are nutritionally depleted, must be extensive and frequent. See Children section under DOSAGE AND ADMINISTRATION for additional information.

Frequent monitoring of blood glucose is required in low birth weight or septic infants as hypertonic dextrose infusion involves a greater risk of hyperglycemia in such patients.

Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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