Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/154
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Aminosyn II (Injection, Solution)
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Each 100 mL of Aminosyn II contains: 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. Some
opacity of the plastic due to moisture absorption during the sterilization
process may be observed. This is normal and does not affect the solution
quality or safety. The opacity will diminish gradually. Aminosyn II in the 2000 mL flexible Pharmacy Bulk Package
is designed for use with manual, gravity flow operations and automated
gravimetric compounding devices for preparing intravenous nutritional
admixtures. Admixtures must be stored under refrigeration and used
within 24 hours of admixing. 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 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
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 2500 and 3000 mL and may be much higher with losses from
fistula drainage orsevere 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. 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. 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,
each liter of central vein TPN solution for adults contains 42.5 to
50 g of Aminosyn II with approximately 250��100 g of dextrose;
supplementary nonprotein calories from intravenous fat emulsion may
be prescribed, at the discretion of the physician. 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 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 rateof 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
250 or 500 mL. Such a solution given at the rate of 145 mL/kg/day
provides 130 kcal/kg/day. Recommended Directions for Use of the Pharmacy Bulk Package Use Aseptic Technique WARNING: Do not use flexible
container in series connections.
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dailymed-instance:descripti... |
Aminosyn II (an amino acid injection)
is a sterile, nonpyrogenic solution for intravenous infusion. Aminosyn
II is oxygen sensitive. The Pharmacy Bulk Package is a sterile dosage
form which contains multiple single doses for use only in a pharmacy
bulk admixture program. The formulations are described below: 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 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. The formulas
for the individual amino acids are as follows: The Pharmacy Bulk Package is designed for
use with manual, gravity flow operations and automated compounding
devices for preparing sterile parenteral nutrient admixtures; it contains
no bacteriostat. Multiple single doses may be dispensed during continual
aliquoting operations. Withdrawal of container contents should be
promptly completed within 4 hours after initial closure puncture.
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dailymed-instance:clinicalP... |
Aminosyn II (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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dailymed-instance:supply |
Aminosyn II is supplied as a Pharmacy Bulk
Package in a 2000 mL flexible container for continuous admixture compounding
procedures. Two concentrations are available: 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. November, 2004
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Pharmacy Bulk Package���Not For Direct Infusion.
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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 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).<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Studies with solutions from flexible plastic containers
have not been performed to evaluate carcinogenic potential, mutagenic
potential or effects on fertility.<br/>Pregnancy Category C.: Animal reproduction studies have not been conducted
with Aminosyn II (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/>Nursing Mothers:: Caution should be exercised when solutions from flexible
plastic containers are administered to a nursing mother.<br/>Geriatric Use: Clinical Studies of Aminosyn II have not been
performed to determine whether patients over 65 years of age 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 an elderly patient should
be cautious, reflecting the greater frequency of decreased hepatic,
renal, or cardiac function, andof concomitant disease or other drug
therapy. This drug is known to be substantially excreted by kidney,
and the risk for 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 function.<br/>Pediatric Use:: Safety and effectiveness of solutions from flexible
plastic containers in pediatric patients have not been well established. 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.<br/>Drug Interactions: Because of its antianabolic activity, concurrent
administration of tetracycline may reduce the potential effects of
amino acids infused with dextrose as part of a parenteral feeding
regimen.
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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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dailymed-instance:genericMe... |
Isoleucine, Leucine, Lysine, Methionine, Phenylalanine, Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid, Histidine, Proline, Serine, N-Acetyl-L-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. 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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dailymed-instance:warning |
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 II
(an amino acid 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. 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 largeamounts 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 even at lower rates of administration.
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Aminosyn II (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. Aminosyn II is also indicated for central vein infusion to
prevent or reverse negative nitrogen balance in patients where the
alimentary tract, by the oral, gastrostomy or jejunostomy route cannot
or should not be used and gastrointestinal absorption of protein is
impaired.
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Aminosyn II
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