
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.
There is currently no manufacturer warning information available for this drug.
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.
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.