Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1253
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Aminosyn II (Injection, Solution)
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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. Adults Solutions
containing 3.5 to 5% amino acids with 5 to 10% glucose 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 7%, 8.5% and
10% solutions 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 2500and 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
II 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 II 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 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
B, 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 7%, 8.5% or 10% solution is used in equal
volume with 50% dextrose to provide an admixture containing 3.5%, 4.25% or
5% amino acids and 25% 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 10% 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 thevolume 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 bemonitored
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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Aminosyn II, Sulfite-Free, (an amino acid
injection) is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn
II is oxygen sensitive. The following formulations are available: *Amount cited is for lysine alone and does not include
the acetate. Contains sodium hydroxide for pH adjustment. Nafrom pH adjustor. Includes
acetate from lysine acetate. The formulas for the individual
amino acids present in Aminosyn II, 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.
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Aminosyn II, Sulfite-Free, (an amino acid injection) provides
crystalline amino acids to promote protein synthesis and wound healing, and
to reduce the rate of endogenous protein catabolism. Aminosyn II, given by
central venous infusion in combination with concentrated dextrose, electrolytes,
vitamins, trace metals, and ancillary fat supplements, constitutes total parenteral
nutrition (TPN). Aminosyn II can also be administered by peripheral vein with
dextrose and maintenance electrolytes. Intravenous fat emulsion may be substituted
for part of the carbohydrate calories during either TPN or peripheral vein
administration of Aminosyn II.
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This preparation should not be used in patients with hepatic
coma or metabolic disorders involving impaired nitrogen utilization.
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Exposure of pharmaceutical products
to heat should be minimized. Avoid excessive heat. Protect from freezing.
Store at 20 to 25��C (68 to 77��F). [See USP Controlled Room Temperature.]Avoid exposure to light. HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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SPECIAL PRECAUTIONS FOR CENTRAL VENOUS INFUSIONS ADMINISTRATION
BY CENTRAL VENOUS CATHETER SHOULD BE USED ONLY BY THOSE
FAMILIAR WITH THIS TECHNIQUE AND ITS COMPLICATIONS.
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Special care must be taken when administering glucose toprovide calories in diabetic or prediabetic patients. 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. SPECIAL PRECAUTIONS FOR CENTRAL VENOUS INFUSIONS ADMINISTRATION
BY CENTRAL VENOUS CATHETER SHOULD BE USED ONLY BY THOSE
FAMILIAR WITH THIS TECHNIQUE AND ITS COMPLICATIONS. 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).<br/>Pregnancy Category C: Animal reproduction studies have not been conducted with
Aminosyn II, Sulfite-Free, (an amino acid injection). It is not known whether
Aminosyn II can cause fetal harm when administered to a pregnant woman or
can affect reproduction capacity. Aminosyn II should be given to a pregnant
woman only if clearly needed.<br/>Geriatric Use: Clinical studies of Aminosyn II 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 adverse 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. Do
not withdraw venous blood for blood chemistries through the peripheral infusion
site, as interference with estimations of nitrogen containing substances may
occur. 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 II contains no more
than 25 mcg/L of aluminum.<br/>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.
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In the event of overhydration or solute overload, re-evaluate
the patient and institute appropriate corrective measures. See WARNINGS and
PRECAUTIONS.
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Isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, Aspartic Acid, Glutamic Acid, histidine, proline, serine, tyrosine and glycine
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Aminosyn II (Injection, Solution)
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Peripheral Infusions A
3.5% to 5% solution of amino acids (without additives) is slightly hypertonic.
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. Electrolyte additives should be spread throughout the day.
Irritating additive medications may need to be infused at another venous site. Generalized
flushing, fever and nausea also have been reported during peripheral infusions
of amino acid solutions.
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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. 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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Aminosyn II, 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
II SOLUTIONS WITHOUT ELECTROLYTES. Aminosyn II 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 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 proteinare 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.
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Aminosyn II
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