Aminosyn Ii With Electrolytes
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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 if BUN levels exceed normal postprandial limits and continue to rise. It should be noted that a modest rise in BUN normally occurs as a result of increased protein intake.
Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, metabolic alkalosis, prerenal azotemia, hyperammonemia, stupor and coma.
Administration of amino acid solutions in the presence of impaired renal function may augment an increasing BUN, as does any protein dietary component.
Solutions containing sodium ion should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency and in clinical states in which there exists edema with sodium retention.
Solutions which contain potassium ion should be used with great care, if at all, in patients with hyperkalemia, severe renal failure and in conditions in which potassium retention is present.
Solutions containing acetate ion should be used with great care in patients with metabolic or respiratory alkalosis. Acetate should be administered with great care in those conditions in which there is an increased level or an impaired utilization of this ion, such as severe hepatic insufficiency.
Aminosyn II 8.5% WITH ELECTROLYTES, Sulfite-Free, (an amino acid injection) may not be suitable for use in infants who require individualized electrolyte therapy.
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.
Instances of asymptomatic hyperammonemia have been reported in patients without overt liver dysfunction. The mechanisms of this reaction are not clearly defined, but may involve genetic defects and immature or subclinically impaired liver function.
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.
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Manufacturer Warnings
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FDA Labeling Changes
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Uses
Aminosyn II 8.5% WITH ELECTROLYTES, Sulfite-Free, (an amino acid injection) infused with dextrose by peripheral vein infusion 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.
Aminosyn II 8.5% WITH ELECTROLYTES can be administered peripherally with dilute (5 to 10%) dextrose solution and I.V. fat emulsion as a source of nutritional support. This form of nutritional support can help to preserve protein and reduce catabolism in stress conditions where oral intake is inadequate.
When administered with concentrated dextrose solution with or without fat emulsions, Aminosyn II 8.5% WITH ELECTROLYTES is also indicated for central vein infusion to prevent or reverse negative nitrogen balance in patients where: (a) the alimentary tract, by the oral, gastrostomy or jejunostomy route cannot or should not be used; (b) gastrointestinal absorption of protein is impaired; (c) metabolic requirements for protein 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.
History
There is currently no drug history available for this drug.
Other Information
Aminosyn® II 8.5% WITH ELECTROLYTES, Sulfite-Free, (an amino acid injection with electrolytes) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn II 8.5% WITH ELECTROLYTES is oxygen sensitive. The following formulation is available:
| Essential Amino Acids (mg/100 mL) |
||
|---|---|---|
| Isoleucine |
561 |
|
| Leucine |
850 |
|
| Lysine (acetate)* |
893 |
|
| Methionine |
146 |
|
| Phenylalanine |
253 |
|
| Threonine |
340 |
|
| Tryptophan |
170 |
|
| Valine |
425 |
|
| * Amount cited is for lysine alone and does not include the acetate salt. |
||
| Nonessential Amino Acids (mg/100 mL) |
|
|---|---|
| Alanine |
844 |
| Arginine |
865 |
| L-Aspartic Acid |
595 |
| L-Glutamic Acid |
627 |
| Histidine |
255 |
| Proline |
614 |
| Serine |
450 |
| N-Acetyl-L-Tyrosine |
230 |
| Glycine |
425 |
| Product Characteristics |
|
|---|---|
| Protein Equivalent (approx. g/liter) |
85 |
| Total Nitrogen (g/liter) |
13.0 |
| Osmolarity (mOsmol/L) |
920 |
| pHa |
5.8 |
| range |
5.0 - 6.5 |
| a Contains sodium hydroxide for pH adjustment. |
|
| Electrolytes (mEq/liter) |
|
|---|---|
| Sodium (Na+)b |
78 |
| Potassium (K+) |
66 |
| Magnesium (Mg++) |
10 |
| Phosphorus mMc |
30 |
| Chloride (Cl¯) |
86 |
| Acetate (C2H3O2‾) |
61d |
| b Includes sodium from the pH adjustor. c mM = millimoles; one mM of phosphorus = 31 mg P. d Includes acetate from lysine acetate. |
|
| Electrolytes (mg/100 mL) |
|
|---|---|
| Sodium Chloridee |
60 mg |
| Magnesium Chloride hexahydratef |
102 mg |
| Sodium Phosphate, dibasicg |
425 mg |
| Potassium Chlorideh |
492 mg |
| e Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water. f Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate, MgCl2 • 6H2O, deliquescent crystals very soluble in water. g Sodium Phosphate, dibasic, USP is chemically designated Na2HPO4, white granules very soluble in water. h Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water. |
|
The formulas for the individual amino acids present in Aminosyn II 8.5% WITH ELECTROLYTES 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 |
|
|---|---|
| Alanine, USP |
C3H7NO2 |
| Arginine, USP |
C6H14N4O2 |
| L-Aspartic Acid |
C4H7NO4 |
| |
HO2CCH2CH(NH2)CO2H |
| L-Glutamic Acid |
C5H9NO4 |
| |
HO2CCH2CH2CH(NH2)CO2H |
| Glycine, USP |
C2H5NO2 |
| Histidine, USP |
C6H9N3O2 |
| Proline, USP |
C5H9NO2 |
| Serine, USP |
C3H7NO3 |
| N-Acetyl-L-Tyrosine |
C11H13NO4 |
| |
|
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 Ii With Electrolytes Manufacturers
-
Hospira, Inc.
![Aminosyn Ii With Electrolytes (Isoleucine, Leucine, Lysine Acetate, Methionine, Phenylalanine, Threonine, Tryptophan, Alanine, Arginine, Histidine, Proline, Serine, Glycine, Valine, Aspartic Acid, N-acetyl-tyrosine, Glutamic Acid, Magnesium Chloride, Sodium Phosphate, Dibasic, Sodium Chloride, And Potassium Chloride) Injection, Solution [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Aminosyn Ii With Electrolytes | Hospira, Inc.
The total daily dose of the solution depends on the daily protein 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.
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.
Central Vein Total Parenteral Nutrition
For central vein infusion with concentrated dextrose solution, alone or with I.V. lipid, the total daily dose of the amino acid solution depends upon daily protein requirements and the patient’s metabolic and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual protein requirements.
Adults
Admixtures of 3.5 to 4.25% amino acids with 5 to 10% dextrose may be infused with a fat emulsion by peripheral vein to provide approximately 1400 to 2000 kcal/day. Fat emulsion administration should be considered when prolonged parenteral nutrition is required in order to prevent essential fatty acid deficiency (E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D. in patients maintained on fat-free TPN.
Aminosyn II 8.5% WITH ELECTROLYTES, Sulfite-Free, (an amino acid injection) should only be infused via a central vein when admixed with sufficient dextrose to provide full caloric requirements in patients who require prolonged total parenteral nutrition. I.V. lipid may be administered to provide part of the calories, if desired. Serum lipids should be monitored for evidence of essential fatty acid deficiency in patients maintained on fat-free TPN.
Total parenteral nutrition (TPN) may be started with 10% dextrose added to the calculated daily requirement of amino acids (1.5 g/kg for a metabolically stable patient). Dextrose content is gradually increased over the next few days to the estimated daily caloric need as the patient adapts to the increasing amounts of dextrose. Each gram of dextrose provides approximately 3.4 kcal. Each gram of fat provides 9 kcal.
The average depleted major surgical patient with complications requires between 2500 and 4000 kcal and between 12 and 24 grams of nitrogen per day. An adult patient in an acceptable weight range with restricted activity who is not hypermetabolic, requires about 30 kcal/kg of body weight/day. Average daily adult fluid requirements are between 2500 and 3000 mL and may be much higher with losses from fistula drainage or in severe burns. Typically, a hospitalized patient may lose 12 to 18 grams of nitrogen a day, and in severe trauma the daily loss may be 20 to 25 grams or more.
Aminosyn II 8.5% WITH ELECTROLYTES is designed to supply necessary electrolytes to patients in a stable metabolic state (about three-fourths of all patients on total parenteral nutrition). Other patients may require more or less of the electrolytes present, e.g., cardiac patients who should not receive sodium. Aminosyn II 8.5% WITH ELECTROLYTES does not contain calcium, and this should be added as indicated.
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.
Calcium and phosphorus are added to the solution as indicated. The usual dose of phosphorus 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 phosphorus additives are potentially incompatible when added to the TPN admixture. However, if one additive is added to the amino acid container, and the other to the container of concentrated dextrose, and if the contents of both containers are swirled 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. Typically, the 8.5% solution is used in equal volume with 50% or 70% dextrose to provide an admixture containing 4.25% amino acids and 25% or 35% dextrose respectively.
The rate of intravenous infusion initially should be 2 mL/min and may be increased gradually. If administration should fall behind schedule, no attempt to “catch up” to planned intake should be made. In addition to meeting protein needs, the rate of administration is governed by the patient’s glucose tolerance estimated by glucose levels in blood and urine.
Aminosyn II 8.5% WITH ELECTROLYTES solution, when mixed with an appropriate volume of concentrated dextrose, offers a higher concentration of calories and nitrogen per unit volume. This solution is indicated for patients requiring larger amounts of nitrogen than could otherwise be provided or where total fluid load must be kept to a minimum, for example, patients with renal failure.
Provision of adequate calories in the form of hypertonic dextrose may require exogenous insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia, do not abruptly discontinue administration of nutritional solutions.
Pediatric
Aminosyn II 8.5% WITH ELECTROLYTES may not be suitable for use in infants whose electrolyte requirements must be “custom tailored” based on serial blood chemistry determinations.
Pediatric requirements for parenteral nutrition are constrained by the greater relative fluid requirements of the infant and greater caloric requirements per kilogram. Amino acids are probably best administered in a 2.5% concentration. For most pediatric patients on intravenous nutrition, 2.5 grams amino acids/kg/day with dextrose alone or with I.V. lipid calories of 100 to 130 kcal/kg/day is recommended. In cases of malnutrition or stress, these requirements may be increased. It is acceptable in pediatrics to start with a nutritional solution of half strength at a rate of about 60 to 70 mL/kg/day. Within 24 to 48 hours the volume and concentration of the solution can be increased until the full strength pediatric solution (amino acids and dextrose) is given at a rate of 125 to 150 mL/kg/day.
Supplemental electrolytes and vitamin additives should be administered as deemed necessary by careful monitoring of blood chemistries and nutritional status. Addition of iron is more critical in the infant than the adult because of the increasing red cell mass required for the growing infant. 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 infants, accurately calibrated and reliable infusion systems should be used.
A basic solution for pediatric use should contain 25 grams of amino acids and 200 to 250 grams of glucose per 1000 mL, administered from containers containing 250 or 500 mL. Such a solution given at the rate of 145 mL/kg/day provides 130 kcal/kg/day.
WARNING: Do not use flexible container in series connections.
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