Package Insert and Label Information: Aminosyn II in Dextrose
AMINOSYN II IN DEXTROSE- dextrose monohydrate, isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, n-acetyl-l-tyrosine and glycine injection, solution
Hospira, Inc.
NOTE: These solutions are hypertonic. See WARNINGS and PRECAUTIONS.
Nutrimix ® Dual-chamber Flexible Container
The Upper Chamber Contains 500 mL of Aminosyn II 7%
(An Amino Acid Injection)
The Lower Chamber Contains 500 mL of 50% Dextrose Injection, USP
Rx only
DESCRIPTION
Upper Chamber: Aminosyn II 7%, an amino acid injection, 500 mL.
Aminosyn II 7% is a sterile, nonpyrogenic solution for intravenous infusion. The formulation is described in the table below.
Lower Chamber: 50% Dextrose Injection, USP, 500 mL.
50% Dextrose Injection, USP (concentrated dextrose in water) is a sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in water for injection. The table below indicates the characteristics of this concentrated solution.
The container must be used only after removing the clamp and thoroughly mixing the contents of the two chambers. The solution resulting from mixing the contents of the upper and the lower chamber will be 3.5% amino acids in 25% dextrose. Mixing the contents of the upper and lower chambers yields a concentrated source of amino acids and carbohydrate calories for intravenous infusion. Headspace contains Nitrogen gas. The composition of this admixture is described in the table below.
| Solution Composition per 100 mL | |||
| Upper Chamber | Lower Chamber | Admixture | |
| Dextrose, hydrous (g) | 50 | 25 | |
| Essential Amino Acids (mg) | |||
| Isoleucine | 462 | 231 | |
| Leucine | 700 | 350 | |
| Lysine (as acetate salt)* | 735 | 368 | |
| Methionine | 120 | 60 | |
| Phenylalanine | 209 | 104 | |
| Threonine | 280 | 140 | |
| Tryptophan | 140 | 70 | |
| Valine | 350 | 175 | |
| Nonessential Amino Acids (mg) | |||
| Alanine | 695 | 348 | |
| Arginine | 713 | 356 | |
| L-Aspartic Acid | 490 | 245 | |
| L-Glutamic Acid | 517 | 258 | |
| Histidine | 210 | 105 | |
| Proline | 505 | 252 | |
| Serine | 371 | 186 | |
| N-Acetyl-L-Tyrosine | 189 | 94 | |
| Glycine | 350 | 175 | |
| Total Amino Acids (g) | 7 | 3.5 | |
| Protein Equivalent (g) | 7 | 3.5 | |
| Total Nitrogen (g) | 1.07 | 0.54 | |
| *Amount cited is for lysine alone and does not include the acetate salt. | |||
| Upper Chamber | Lower Chamber | Admixture | |
| Electrolytes (mEq/liter) | |||
| Sodium a (Na+) | 36 | 18 | |
| Acetate b (C2 H3 O2 −) | 50.3 | 25.2 | |
| Sodium hydrosulfite (mg/100 mL) | 60 | 30 | |
| Osmolarity mOsmol/liter (actual) | 647 | 1997 | 1515 |
| pH | 5.8 | 4.3 | 5.8 |
| range | 5.0 to 6.5 c | 3.2 to 6.5 | 5.0 to 6.5 |
The formulas for the individual amino acids present are as follows:
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|
| _______________________________________________________________________________ |
| aIncludes sodium from the pH adjustor sodium hydroxide and the antioxidant, sodium hydrosulfite. |
| bIncludes acetate from lysine acetate. |
| cMay contain sodium hydroxide for pH adjustment. |
Dextrose, USP is chemically designated D-glucose, monohydrate (C6 H12 O6 • H2 0), a hexose sugar freely soluble in water.
The flexible plastic container is fabricated from a specially formulated nonplasticized thermoplastic co-polyester (CR3). Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions inside the plastic container also can leach out certain of its chemical components in very small amounts before the expiration period is attained. However, the safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers.
CLINICAL PHARMACOLOGY
The Aminosyn II 3.5% in 25% Dextrose Injection admixture, obtained upon mixing thoroughly the contents of the two chambers, provides carbohydrate calories and crystalline amino acids to stimulate protein synthesis, to limit protein catabolism, to minimize liver glycogen depletion and to promote wound healing. The infusion of this mixture through a central venous line should be considered to meet protein and calorie requirements for patients requiring prolonged total parenteral nutrition. I.V. lipids may be infused simultaneously to provide adequate calories, if desired.
Aminosyn II in Dextrose Indications and Usage
Aminosyn II 3.5% in 25% Dextrose Injection is indicated for central vein infusion in the prevention of nitrogen loss and negative nitrogen balance in cases where (a) the gastrointestinal tract by the oral, gastrostomy or jejunostomy route cannot or should not be used, (b) gastrointestinal absorption of nutrients is impaired or (c) metabolic requirements for protein and calories 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. In such patients intravenous feeding for more than a few days would be expected.
The addition of supplemental electrolytes, will be required in accordance with the prescription of the attending physician.
CONTRAINDICATIONS
This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.
WARNINGS
The Aminosyn II 3.5% in 25% Dextrose Injection admixture is hypertonic and may not be administered by peripheral vein.
Concentrated dextrose solutions, if administered too rapidly, may result in significant hyperglycemia and possible hyperosmolar syndrome, characterized by mental confusion and loss of consciousness.
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 solution 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 containing potassium ions 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 3.5% in 25% Dextrose Injection contains sodium hydrosulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
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.
Hyperammonemia is of special significance in infants, as it can result in mental retardation. Therefore, it is essential that blood ammonia levels be monitored frequently in infants.
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
Special care must be taken when administering concentrated glucose to diabetic or prediabetic patients. To control and minimize hyperglycemia and consequent glycosuria, it is desirable to monitor blood and urine glucose and, if necessary, add insulin.
Because of its antianabolic activity, concurrent administration of tetracycline may reduce the nitrogen sparing effects of infused amino acids.
Feeding regimens which include amino acids should be used with caution in patients with history of renal disease, pulmonary disease, or with cardiac insufficiency so as to avoid excessive fluid accumulation.
Nitrogen intake should be carefully monitored in patients with impaired renal function.
Aminosyn II 3.5% in 25% Dextrose Injection is indicated for long-term total parenteral nutrition and whenever it is essential to provide, together with amino acids, adequate amounts of exogenous calories. Concentrated dextrose is an effective source of such calories. Such strongly hypertonic nutrient solutions should be administered only through an indwelling catheter with the tip located in a large vein: i.e., the superior vena cava.
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 of nutrient 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 (See also Current Medical Literature).
1. Technical:
The placement of a central venous catheter should be regarded as a surgical procedure. One should be fully acquainted with various techniques of catheter insertion. For details of technique and placement sites, consult the medical literature. 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 constant risk of sepsis is present 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 be used promptly after mixing. Storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours.
Administration time for a single container and set should never exceed 24 hours.
3. Metabolic:
The following metabolic complications have been reported: Metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, hyperglycemia, hyperosmolar nonketotic states and dehydration, glycosuria, rebound hypoglycemia, osmotic diuresis and dehydration, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances and hyperammonemia in children. Frequent evaluations are necessary especially during the first few days of therapy to prevent or minimize these complications.
Administration of glucose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma and death.
