Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1877
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Aminosyn II and Dextrose (Injection, Solution)
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The total daily dose of Aminosyn II 4.25% in 25% Dextrose
Injection to be infused depends on daily protein and caloric 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. As
reported in the literature, the dosage and constant infusion rate of intravenous
dextrose must be selected with caution in pediatric patients, particularly
neonates and low birth weight infants, because of the increased risk of hyperglycemia/
hypoglycemia. As with all intravenous fluid therapy,
the parenteral administration of a solution of amino acids and dextrose requires
an accurate estimate of the total fluid and electrolytes needed to compensate
for the patient's measurable urinary and other (i.e., nasogastric suction,
fistula drainage, diarrhea) daily losses. After estimating the total daily
fluid (water) requirements, the appropriate volume to be infused to meet the
daily protein requirement of the patient, can be determined. The balance of
fluid needed beyond the volume of the amino acid/dextrose solution can be
provided by other solutions suitable for intravenous infusion. Lipid emulsion
can be administered to provide up to 3 g fat/kg/day, infused simultaneously
with Aminosyn II 4.25% in 25% Dextrose Injection by means of a Y-connector
located near the infusion site, using separate flow controls for each solution.
Aminosyn II 4.25% in 25% Dextrose Injection should not be premixed with fat
emulsion. Vitamins and trace minerals may be added to the amino acid/dextrose
solution as needed. Parenteral drug products should
be inspected visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. The total daily
dose of the amino acid/dextrose solution to be infused depends on daily protein
requirements and on the patient's metabolic and clinical response.
The daily determination of nitrogen balance and accurate body weights, corrected
for fluid balance, are probably the best means of assessing individual protein
requirements. Adults The
daily nutrient requirements of an average adult patient, not hypermetabolic,
in an acceptable weight range and with restricted physical activity, are about
30 kcal/kg of body weight, 12 to 18 grams of nitrogen and between 2500
and 3000 mL of fluids. In depleted and severely traumatized patients such
as burned patients or patients who have received major surgery with complications,
the requirements for nutrients and fluids may be significantly higher. In
such cases, 4000 calories and 25 grams of nitrogen or more may be required
daily to achieve nitrogen balance. The fluid losses through drainages and
wound surface must be taken into account in calculating the fluid requirements
of these patients. Fat emulsion administration should
be considered when prolonged parenteral nutrition is required in order to
prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored
for evidence of EFAD in patients maintained on fat-free TPN. Each
gram of dextrose provides approximately 3.4 calories���1000 mL of Aminosyn
II 4.25% in 25% Dextrose Injection will provide 6.5 grams of nitrogen and
850 calories. The infusion rate of Aminosyn II 4.25% in 25% Dextrose Injection
should be 2 mL/min initially and may be gradually increased to deliver the
required amounts of amino acids and calories. If nutrient administration falls
behind schedule, under no circumstances should an attempt to���catch
up���to planned intake be made. The rate of nutrient infusion is governed
by the protein requirements and by the patient's glucose tolerance
estimated by glucose levels in plasma and urine. The maximum rate at which
dextrose can be infused without producing glycosuria is 0.5 g/kg/hour; at
a rate of 0.8 g/kg/hour, about 95% of the infused dextroseis retained. Administration
of exogenous insulin may be required in order to control hyperglycemia and
glycosuria which may occur upon infusion of concentrated glucose solutions.
When concentrated dextrose infusion is abruptly interrupted rebound hypoglycemia
may occur, which can be prevented by the administration of 5% or 10% dextrose
solutions. Part of the caloric requirements may be met by the infusion of
I.V. fat emulsions. SERUM ELECTROLYTES SHOULD BE MONITORED
AS INDICATED. Electrolytes should 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. Adding 20 mL of TPN Electrolytes
(List 5779) to the amino acid chamber and 5 mL of Potassium Phosphate (List
7296) to the dextrose chamber will result in final admixture concentrations
(in mEq/L) as follows: 54 sodium, 42 potassium, 35
chloride, 5 magnesium, 4.5 calcium, 60.1 acetate, and 15 (mM) phosphate.
Alternate electrolyte additives may be used at the clinician's discretion. 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 solution, and the other to the concentrated
dextrose solution, and if the contents of both chambers are mixed 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. Pediatric Pediatric requirements for parenteral nutrition
are constrained by the greater relative fluid requirements of the infant and
greater caloric requirements per kilogram. A 4.25% amino acid solution is
too concentrated for use in pediatric patients less than 1 year old, who generally
receive a 2.5% amino acid solution. However, older pediatric patients can
receive Aminosyn II 4.25% in 25% Dextrose Injection. The suggested amino acid
dosage level for childrenbetween 4 and 12 years of
age is 2 g/kg/day; for 13 to 15 years of age, 1.7 g/kg/day; and for 16
years of age and above, 1.5 g/kg/day. Energy requirements for children between
1 and 7 years of age are approximately 75 to 90 kcal/kg/day; for children
7 to 12 years of age, 60 to 75 kcal/kg/day; and for ages 12 to 18 years, 30 to
60 kcal/kg/day. Energy intake may be supplemented with intravenous fat emulsion.
In cases of malnutrition or stress, these requirements may be increased. Supplemental
electrolytes and vitamin additives should be administered as deemed necessary
by careful monitoring of blood chemistries and nutritional status. Iron supplementation
is more critical in the child than the adult because of the increasing red
cell mass required by the growing child. 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 children, accurately calibrated and reliable infusion
systems should be used. Drug
Interactions Additives may be incompatible.
Consult with pharmacist, if available. When introducing additives, use aseptic
technique, mix thoroughly and do not store. INSTRUCTIONS FOR USE DO NOT USE IF AMINOSYN II IS DISCOLORED OR IF CLAMP IS OPEN
OR MISSING. COLOR VARIATION IN THE DEXTROSE INJECTION FROM PALE YELLOW TO
YELLOW IS NORMAL AND DOES NOT ALTER EFFICACY. To Open: Tear outer wrap
at notch. After removing the overwrap, check for minute leaks by squeezing
the container firmly. If leaks are found, discard solution as sterility may
be impaired. If supplemental medication is desired, follow directions below
before preparing for administration. To
Add Medication: Preparation for Administration (Use aseptic technique) WARNING: Do not use flexible container
in series connections.
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Upper Chamber: Aminosyn
II 8.5%, an amino acid injection, 500 mL. Aminosyn II
8.5% 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 4.25% amino acids in 25% dextrose.
Mixing the contents of the upper and lower chambers yields a concentratedsource of amino acids and carbohydrate calories for intravenous infusion.
Headspace contains Nitrogen gas. The composition of this admixture is described
in the table below. The formulas for the individual amino acids are as follows: Dextrose, USP is chemically designated D-glucose, monohydrate
(CHO���HO), 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.
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The Aminosyn II 4.25% 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 the protein and calorie requirements
for patients receiving prolonged total parenteral nutrition. I.V. lipids may
be infused simultaneously to provide adequate calories, if desired.
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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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Aminosyn II 4.25% in 25% Dextrose Injection
is supplied in a 1000 mL volume dual-chamber flexible container (List No.
7702). Aminosyn II 4.25% in 25% Dextrose Injection is obtained by opening
the clamp separating the two chambers and mixing the contents of the upper
chamber, 500 mL of Aminosyn II 8.5% and the lower chamber, 500 mL of
50% Dextrose Injection, USP. Exposure of pharmaceutical
products to heat should be minimized. Avoid excessive heat. Protect from freezing.
It is recommended that the product be stored at room temperature (25��C);
however, brief exposure up to 40��C does not adversely affect the product. Avoid exposure to light. To prevent breakage, handle cold or refrigerated (2��C
to 8��C) co-polyester (CR3) containers with care. Rev:
May, 2004 ��Hospira 2004 EN-0129 Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA
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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 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. Intravenously
administered 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 4.25% 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.<br/>Pregnancy Category C.: Animal reproduction studies have not been conducted with
Aminosyn II 4.25% in 25% Dextrose Injection. It is not known whether this
admixture can cause fetal harm when administered to a pregnant woman or can
affect reproductive capacity. Aminosyn II 4.25% in 25% Dextrose Injection
should be given to pregnant women only if clearly needed.<br/>Geriatric Use: Clinical Studies of Aminosyn II in Dextrose Injection 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, and
of concomitant disease or other drug therapy. This drug is known to be substantially
excreted by the kidney, and therisk 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 Usage: Due to their concentration, these solutions are not recommended
for use in pediatric patients less than 1 year old. Frequent monitoring of
serum glucose concentrations is required when dextrose is prescribed to pediatric
patients, particularly neonates and low birth weight infants. 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 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. Do not use unless the solutions are clear
and container is undamaged. Discard unused portion. Do
not use if solution in either chamber is discolored or if clamp is open or
missing. This product contains no more than 25 mcg/L
of aluminum.
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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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Dextrose monohydrate, 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 and Dextrose (Injection, Solution)
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dailymed-instance:adverseRe... |
Hyperosmolar syndrome, resulting from excessively rapid administration
of concentrated dextrose may cause mental confusion and/or loss of consciousness. Reactions
which may occur because of the solution or the technique of administration
include febrile response, infection at the site of injection, venous thrombosis
or phlebitis extending from the site of injection, extravasation and hypervolemia. Generalized
flushing, fever and nausea also have been reported during peripheral infusions
of amino acid solutions. If an adverse reaction does
occur, discontinue the infusion, evaluate the patient, institute appropriate
therapeutic countermeasures and save the remainder of the fluid for examination
if deemed necessary.
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The Aminosyn II 4.25% 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 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
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 4.25% 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. This solution (4.25% Aminosyn
II) is too concentrated for administration to 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 contains 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 4.25% 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.
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Aminosyn II and Dextrose
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