Aminosyn Rf
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Questions & Answers
Side Effects & Adverse Reactions
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.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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.
History
There is currently no drug history available for this drug.
Other Information
Aminosyn®-RF 5.2%, Sulfite-Free, (an amino acid injection — renal formula) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn-RF 5.2% is oxygen sensitive. The solution contains the following crystalline amino acids:
| mg/100 mL |
Min. Daily Need (mg**) |
|
| Essential Amino Acids |
||
| Isoleucine |
462 |
700 |
| Leucine |
726 |
1100 |
| Lysine Acetate* |
535 |
800 |
| Methionine |
726 |
1100 |
| Phenylalanine |
726 |
1100 |
| Threonine |
330 |
500 |
| Tryptophan |
165 |
250 |
| Valine |
528 |
800 |
| Nonessential Amino Acids |
||
| Arginine |
600 |
__ |
| Histidine*** |
429 |
__ |
*Amount cited is for Lysine alone and does not include the acetate salt.
**The minimum daily quantities needed to maintain nitrogen balance in the healthy adult. (Rose, W.C., The Sequence of Events Leading to the Establishment of the Amino Acid Needs of Man, Am J. Public Health, 58:2020, 1968.)
***Histidine is considered essential for patients in renal failure.
Electrolytes and Product Characteristics
| Aminosyn |
5.2% |
| Acetate (C2H3O2−)a (mEq/Liter) |
113 |
| Protein Equivalent (approx. grams/liter) |
52.27 |
| Total Nitrogen (grams/liter) |
7.93 |
| Osmolarity (mOsmol/liter) |
427 |
| pH (Range) |
5.2 (4.5 to 6.0b) |
a Includes acetate from acetic acid used in processing and from Lysine acetate.
b Adjusted with acetic acid.
Each 500 mL represents three Rose Units of essential amino acids plus arginine and histidine.
The formulas for the individual amino acids present in Aminosyn-RF 5.2% are as follows:
| Essential Amino Acids |
|
| Isoleucine, USP |
(C6H13NO2) |
| Leucine, USP |
(C6H13NO2) |
| Lysine Acetate, USP |
(C6H14N2O2 • CH3COOH) |
| Methionine, USP |
(C5H11NO2S) |
| Phenylalanine, USP |
(C9H11NO2) |
| Threonine, USP |
(C4H9NO3) |
| Tryptophan, USP |
(C11H12N2O2) |
| Valine, USP |
(C5H11NO2) |
| Nonessential Amino Acids |
|
| Arginine, USP |
(C6H14N4O2) |
| Histidine, USP |
(C6H9N3O2) |
The flexible plastic container is fabricated from a specially formulated polyvinylchloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly.
Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.
Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
Sources
Aminosyn Rf Manufacturers
-
Hospira, Inc.
![Aminosyn Rf (Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Arginine, And Histidine) Injection, Solution [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Aminosyn Rf | Hospira, Inc.
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.
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