Aminosyn-RF

Name: Aminosyn-RF

Indications and Usage for Aminosyn-RF

Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection renal formula) is indicated only as an adjunct to management of patients with potentially reversible acute renal failure who are unable to eat. When infused with hypertonic dextrose as a source of calories and with added appropriate electrolytes and vitamins, Aminosyn-RF 5.2% is suitable as an intravenous source of protein in a parenteral nutritional regimen for such patients.

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.

Adverse Reactions

Adverse effects include metabolic, fluid, electrolyte and acid-base imbalances unless appropriate monitoring and corrective management are accomplished during Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection renal formula) therapy.

Aminosyn-RF Dosage and Administration

Dosage

Fat emulsion coadministration should be considered when prolonged (more than 5 days) 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.

Adults: The objective of nutritional management of renal decompensation is to provide sufficient amino acid and caloric support for protein synthesis without exceeding the renal capacity to excrete metabolic wastes.

A dosage of 2.4 to 4.7 grams of nitrogen per day (from essential amino acids) with adequate calories will maintain nitrogen equilibrium in patients with uremia. If more nitrogen and calories are required in severely stressed patients in acute renal failure who cannot eat, higher dosages may be administered provided great care is taken to avoid exceeding limits of fluid intake or glucose tolerance.

In general, dosage should be guided by fluid, glucose and nitrogen tolerances, as well as the metabolic and clinical response. The rate of rise in BUN generally diminishes with infusion of essential amino acids. However, excessive intake of protein or increased protein catabolism may alter this response.

The usual daily dose ranges from 300 to 600 mL of Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection renal formula) equivalent to 2.4 to 4.7 grams of nitrogen in 15.7 to 31 grams of essential amino acids. Adequate calories should be administered simultaneously. Each 500 mL of Aminosyn-RF 5.2% mixed under sterile conditions with 832 mL of Dextrose 70% will provide a solution of 1.95% of Aminosyn-RF 5.2% in 44% dextrose. This mixture provides a calorie-to-nitrogen ratio of 504:1.

Electrolyte supplementation may be required.

Elevated phosphorus, potassium and magnesium levels generally decrease during treatment with Aminosyn-RF 5.2%. Particular care should be taken in the presence of cardiac arrhythmias or digitalis toxicity to assure that sufficient quantities of these electrolytes are provided when necessary.

Compatibility of electrolyte additives to the mixtures of Aminosyn-RF 5.2% and hypertonic dextrose must be considered and potentially incompatible ions (calcium, phosphate) may be added to alternate infusion bottles to avoid precipitation.

Children: Pediatric requirements for Aminosyn-RF 5.2% vary greatly depending upon growth, nutritional state and degree of renal insufficiency. A dosage of 0.5 to 1 gram of essential amino acids per kilogram of body weight per day will meet the requirements of the majority of pediatric patients. Initial daily dosage of Aminosyn-RF 5.2% should be low and increased slowly; more than one gram of essential amino acids per kilogram of body weight per day is not recommended. The total volume of nutritional solution and the rate at which it is administered will vary with the child’s age, nutritional and growth state, as well as the degree of renal failure. See Special Precautions in Pediatric Patients for additional information.

Administration

Aminosyn-RF 5.2% admixed with sufficient dextrose to provide caloric energy requirements may be safely administered via a central venous catheter with the tip located in the vena cava.

Initial infusion rates should be slow, generally 20 to 30 mL/hour for the first 6 to 8 hours. Increments of 10 mL/hour for each hour are suggested up to a maximum rate of 60 to 100 mL/hour. If administration rates fall behind the scheduled 24 hour dosage, no attempt should be made to catch up to the planned intake. The patient’s fluid, nitrogen and glucose tolerance should be the governing factor of the rate of administration. Uremic patients are frequently glucose intolerant especially in association with peritoneal dialysis; insulin may be required to prevent hyperglycemia. When hypertonic dextrose infusion is abruptly discontinued, rebound hypoglycemia may be prevented by administering 5% dextrose.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. COLOR VARIATION FROM PALE YELLOW TO YELLOW IS NORMAL AND DOES NOT ALTER EFFICACY.

WARNING: Do not use flexible container in series connections.

How is Aminosyn-RF Supplied

Aminosyn-RF 5.2%, Sulfite-Free, (an amino acid injection renal formula) is supplied in 500 mL single-dose containers (NDC No. 0409–4166–03).

Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Avoid exposure to light.

Revised: June, 2008

EN-1813

Printed in USA

Hospira, Inc., Lake Forest, IL 60045 USA

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if you have any side effects that bother you or do not go away.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of Aminosyn-RF may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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