Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/41
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Aminosyn (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. COLOR VARIATION FROM PALE
YELLOW TO YELLOW IS NORMAL AND DOES NOT ALTER EFFICACY. Adults 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. Fat emulsion coadministration
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 EFAD in patients maintained
on fat-free total parenteral nutrition. Aminosyn
5%, 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 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 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 phosphate additives are potentially incompatible
when added to the TPN admixture. However, if one additive is added
to the amino acid bottle, and the other to the bottle of concentrated
dextrose, and if the contents of both bottles 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. 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% 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.<br/>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 insure 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 bottles 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, Sulfite-Free, (a crystalline
amino acid solution) is a sterile, nonpyrogenic solution for intravenous
infusion. Aminosyn is oxygen sensitive. Five different formulations
are available: The formulas for the individual amino acids present
in Aminosyn 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, Sulfite-Free, (a crystalline amino acid
solution) provides crystalline amino acids to promote protein synthesis
and wound healing, and to reduce the rate of endogenous protein catabolism.
Aminosyn, given by central venous infusion in combination with concentrated
dextrose, electrolytes, vitamins, trace metals, and ancillary fat
supplements, constitutes total parenteral nutrition (TPN). Aminosyn
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.
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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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Protect from freezing. Store at 20 to 25��C
(68 to 77��F). [See USP Controlled Room Temperature.] Avoid exposure to light. Revised: April, 2008
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SPECIAL PRECAUTIONS FOR
CENTRAL 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
to provide 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 indwellingintravenous
catheter with the tip located in 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 (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. It is not known whether Aminosyn, Sulfite-Free, (a
crystalline amino acid solution) can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. Aminosyn
should be given to a pregnant woman only if clearly needed.<br/>Geriatric Use: Clinical studies of Aminosyn 3.5% 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.
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 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 acetate, methionine, phenylalanine, threonine,
tryptophan, valine, alanine, arginine, histidine, proline, serine,
tyrosine, and glycine
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Aminosyn (Injection, Solution)
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Peripheral Infusions A 4.25 or 5% solution of amino acids (without
additives) is slightly hypertonic. A 3.5% concentration 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 injected 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. Aminosyn, Sulfite-Free, (a crystalline amino acid solution)
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.
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Aminosyn, Sulfite-Free, (a crystalline amino acid
solution) 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 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 solutions with or without fat emulsions,
Aminosyn 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.
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Aminosyn
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