Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3032
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Aminosyn II in Dextrose (Injection, Solution)
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The total daily dose of Aminosyn II 3.5% 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, electrolytes and acid-base 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.
I.V. lipid emulsions may also be infused to deliver additional calories
if required. Lipid emulsion can be administered to provide up to 3
g fat/kg/day, infused simultaneously with Aminosyn II 3.5% in 25%
Dextrose Injection by means of a Y-connector located near the infusion
site, using separate flow controls for each solution. Aminosyn II
3.5% in 25% Dextrose Injection should not be premixed with fat emulsions.
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 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 3.5% in 25% Dextrose Injection will provide 5.6 grams
of nitrogen and 850 calories. The infusion rate of Aminosyn II 3.5%
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 dextrose
is 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: 53
sodium, 42 potassium, 35 chloride, 5 magnesium, 4.5 calcium,
54.7 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 3.5% amino acid solution is too concentrated for use
in pediatric patients less than 1 year old, who generally require
a 2.5% amino acid solution. However, older pediatric patients can
receive Aminosyn II 3.5% in 25% Dextrose Injection. The
suggested amino acid dosage level for children between 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. Energyintake 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 7%, an amino acid injection, 500 mL. Aminosyn II 7% 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 3.5% amino acids in 25% dextrose. Mixing the contents
of the upper and lower chambers yields a concentrated source of amino
acids and carbohydrate calories for intravenous infusion. Headspace
containsNitrogen gas. The composition of this admixture is described
in the table below. The formulas for the individual amino acids present
are as follows: Dextrose, USP is chemically designated D-glucose,
monohydrate (CHO���H0), 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 3.5% 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
protein and calorie requirements for patients requiring 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 3.5% in 25% Dextrose
Injection is supplied in a 1000 mL volume dual-chamber flexible container.
(List No. 7700). Aminosyn II 3.5% 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 7% 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. Revised: May,
2004 ��Hospira 2004EN-0127Printed
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. 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. Nitrogen
intake should be carefully monitored in patients with impaired renal
function. Aminosyn II 3.5% 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 3.5% 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 3.5% 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 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 shouldbe 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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Isoleucine, Leucine, Lysine acetate, Methionine, Phenylalanine, Threonine,
Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic Acid,
Histidine, Proline, Serine, N-Acetyl-L-Tyrosine, Glycine and Dextrose monohydrate
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Aminosyn II in Dextrose (Injection, Solution)
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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 3.5% 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 inBUN 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 solution 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 3.5% 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. 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. Hyperammonemia
is of special significance in infants, as it can result in mental
retardation. Therefore, it is essential that blood ammonia levels
be monitored frequently in infants. 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 3.5% 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 in Dextrose
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