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Overview
What is Aminosyn Sulfite Free?
Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn 10% (pH 6) is oxygen sensitive.
The formulas for the individual amino acids present in Aminosyn 10% (pH 6) are as follows:
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.
What does Aminosyn Sulfite Free look like?
What are the available doses of Aminosyn Sulfite Free?
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What should I talk to my health care provider before I take Aminosyn Sulfite Free?
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How should I use Aminosyn Sulfite Free?
Aminosyn 10% (pH 6), 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 with
adequate stores of body fat, in whom, for short periods of time, oral
nutrition cannot be tolerated, is undesirable, or inadequate.
SUPPLEMENTAL ELECTROLYTES, IN ACCORDANCE WITH THE PRESCRIPTION
OF THE ATTENDING PHYSICIAN, MUST BE ADDED TO AMINOSYN SOLUTIONS WITHOUT
ELECTROLYTES.
Aminosyn 10% (pH 6) can be administered
peripherally with dilute (5% to 10%) dextrose solution and I.V. fat
emulsion as a source of nutritional support in patients who, while
not hypermetabolic, cannot be satisfactorily maintained on peripheral
intravenous nutrition. 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 solutions with or without fat emulsions,
Aminosyn 10% (pH 6) 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.
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.
1. Peripheral Vein Nutritional
Maintenance
Aminosyn 10% (pH 6), Sulfite-Free,
(an amino acid injection) may be diluted with 5% to 10% Dextrose Injection
to achieve a final amino acid concentration of 3.5, 4.25 or 5% for
peripheral administration.
For peripheral intravenous
infusion, 1.0 to 1.5 g/kg/day of total amino acids will achieve optimal
fat mobilization and reduce protein catabolism. Infusion or ingestion
of carbohydrate or lipid will not reduce the nitrogen sparing effect
of intravenous amino acid infusions at this dose.
As with all intravenous fluid therapy, the primary aim is to provide
sufficient water to compensate for insensible, urinary and other (nasogastric
suction, fistula drainage, diarrhea) fluid losses. Total fluid requirements,
as well as electrolyte and acid-base needs, should be estimated and
appropriately administered.
For an amino acid
solution of specified total concentration, the volume required to
meet amino acid requirements per 24 hours can be calculated. After
making an estimate of the total daily fluid (water) requirement, the
balance of fluid needed beyond the volume of amino acid solution required
can be provided either as a noncarbohydrate or a carbohydrate-containing
electrolyte solution. I.V. lipid emulsion may be substituted for part
of the carbohydrate containing solution. Vitamins and additional electrolytes
as needed for maintenance or to correct imbalances may be added to
the amino acid solution.
If desired, only one-half
of an estimated daily amino acid requirement of 1.5 g/kg can be given
on the first day. Amino acids together with dextrose in concentrations
of 5% to 10%, infused into a peripheral vein can be continued while
oral nutrition is impaired. However, if a patient is unable to take
oral nourishment for a prolonged period of time, institution of total
parenteral nutrition with exogenous calories should be considered.
2. 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
Diluted solutions
containing 3.5 to 5% amino acids with 5 to 10% glucose may be coinfused
with a fat emulsion by peripheral vein to provide approximately 1400
to 2000 kcal/day.
Aminosyn 10% (pH 6) solution
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
separately to provide part of the calories, if desired.
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 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 solutions without electrolytes
are intended for patients requiring individualized electrolyte therapy.
Sodium, chloride, potassium, phosphate, calcium and magnesium are
major electrolytes which should be added to Aminosyn as required.
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 phosphate added to a liter of TPN solution (containing 25% dextrose)
is 12mM. This requirement is related to the carbohydrate calories
delivered. Iron is added to the solution or given intramuscularly
in depot form as indicated. Vitamin B, vitamin K and
folic acid are given intramuscularly or added to the solution as desired.
Calcium and phosphate 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 10% solution is used in equal volume with 50% dextrose to provide
an admixture containing 5% amino acids and 25% dextrose.
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 10% (pH 6) 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
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 500 mL or less. Such a solution given at
the rate of 145 mL/kg/day provides 130 kcal/kg/day.
WARNING:
What interacts with Aminosyn Sulfite Free?
This preparation should not be used in patients with hepatic coma or metabolic disorders involving impaired nitrogen utilization.
What are the warnings of Aminosyn Sulfite Free?
Misoprostol should not be used for reducing the risk of NSAID-induced ulcers in women of childbearing potential unless the patient is at high risk of complications from gastric ulcers associated with use of the NSAID, or is at high risk of developing gastric ulceration. In such patients, misoprostol may be prescribed if the patient
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.
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.
Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection)
can be infused simultaneously with fat emulsion by means of a Y-connector
located near the infusion site using separate flow rate controls for
each solution.
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.
What are the precautions of Aminosyn Sulfite Free?
Special care must be taken when administering glucose to provide calories in diabetic or prediabetic patients.
Do not withdraw venous blood for blood chemistries through the peripheral infusion site, as interference with estimations of nitrogen containing substances may occur.
Intravenous 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.
The effect of infusion of amino acids, without dextrose, upon carbohydrate metabolism of children is not known at this time.
Nitrogen intake should be carefully monitored in patients with impaired renal function. For long-term total nutrition, or if a patient has inadequate fat stores, it is essential to provide adequate exogenous calories concurrently with the amino acids. Concentrated dextrose solutions are an effective source of such calories. Such strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.
Central vein infusion (with added concentrated 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 (consult 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 ideally be prepared in the hospital pharmacy in 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.
Administration time for a single container and set should never exceed 24 hours.
3. Metabolic
The following metabolic complications have been reported with TPN administration: metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, glycosuria, hyperglycemia, hyperosmolar nonketotic states and dehydration, 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.
Pregnancy Category C
Animal reproduction studies have not been conducted with Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection). It is not known whether Aminosyn 10% (pH 6) can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Aminosyn 10% (pH 6) should be given to a pregnant woman only if clearly needed.
Geriatric Use
Clinical studies of Aminosyn 10% (pH 6) 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 toxic 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.
CLINICAL EVALUATION 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, ammonia, cholesterol, acid-base balance, serum proteins, kidney and liver function tests, osmolarity and hemogram. White blood count and blood cultures are to be determined if indicated. Urinary osmolality and glucose should be determined as necessary.
Aminosyn 10% (pH 6) contains no more than 25 mcg/L of aluminum.
Drug Interactions
Because of its antianabolic activity, concurrent administration of tetracycline may reduce the potential anabolic effects of amino acids infused with dextrose as part of a parenteral feeding regimen.
Additives may be incompatible. Consult with pharmacist if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
What are the side effects of Aminosyn Sulfite Free?
Peripheral Infusions
Aminosyn 10% (pH 6), Sulfite-Free, (an amino
acid injection) is hypertonic and must be diluted prior to administration
by peripheral vein. Local reactions consisting of a warm sensation,
erythema, phlebitis and thrombosis at the infusion site have occurred
with peripheral intravenous infusion of amino acids particularly if
other substances, such as antibiotics, are also administered through
the same site. In such cases the infusion site should be changed promptly
to another vein. Use of large peripheral veins, inline filters, and
slowing the rate of infusion may reduce the incidence of local venous
irritation. Simultaneous administration of Aminosyn/dextrose admixtures
with intravenous lipid emulsion may reduce the likelihood of peripheral
vein irritation. Electrolyte additives should be spread throughout
the day. Irritating additive medications may need to be injected at
another venous site.
Generalized flushing, fever
and nausea also have been reported during peripheral infusions of
amino acid solutions.
What should I look out for while using Aminosyn Sulfite Free?
This preparation should not be used in patients with
hepatic coma or metabolic disorders involving impaired nitrogen utilization.
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.
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.
Aminosyn 10% (pH 6), Sulfite-Free, (an amino acid injection)
can be infused simultaneously with fat emulsion by means of a Y-connector
located near the infusion site using separate flow rate controls for
each solution.
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.
What might happen if I take too much Aminosyn Sulfite Free?
In the event of overhydration or solute overload, re-evaluate the patient and institute appropriate corrective measures. See and .
How should I store and handle Aminosyn Sulfite Free?
Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).Storage and HandlingStore at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) (see USP Controlled Room Temperature).Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Revised: June, 2008Printed in USA EN-1818Hospira, Inc., Lake Forest, IL 60045 USAStore at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Revised: June, 2008Printed in USA EN-1818Hospira, Inc., Lake Forest, IL 60045 USAStore at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Revised: June, 2008Printed in USA EN-1818Hospira, Inc., Lake Forest, IL 60045 USAStore at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. Revised: June, 2008Printed in USA EN-1818Hospira, Inc., Lake Forest, IL 60045 USA
