Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3083
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Aminosyn II in Dextrose (Injection, Solution)
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The total daily dose of Aminosyn II 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 areabruptly 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. 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 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 5% 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 amino acid/dextrosesolution 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 (or 1.0 to 1.5 g amino acids/kg/day)
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 5% in 25% Dextrose Injection will provide 7.7 grams of nitrogen and 850
calories. The infusion rate of Aminosyn II 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: 57.2 sodium, 42 potassium, 35 chloride, 5 magnesium,
4.5 calcium, 65.4 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 to 15 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 5% amino acid solution is too
concentrated for use in pediatric patients less than one year old, who generally
receive a 2 to 2.5% amino acid solution. However, older pediatric patients
can tolerate amino acids in concentrations of up to 5%. Dosage is usually
prescribed on a g/kg body weight/day basis and patient age as follows: infants,
2 to 3 g/kg/day; ages 1 to 3 years, 2 to 2.5 g/kg/day; ages 4 to 12 years,
2 g/kg/day; ages 13 to 15 years, 1.7 g/kg/day; ages 16 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 necessaryby 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: Additives may be incompatible.
See DOSAGE AND ADMINISTRATION. Preparation for Administration (Use aseptic technique) WARNING: Do not use flexible container
in series connections.
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Upper Chamber: Contains
500 mL of Aminosyn II 10% (an amino acid injection)���a sterile, nonpyrogenic
solution for intravenous infusion. The formulation is described in the table
below. Lower Chamber: Contains
500 mL of 50% Dextrose Injection, USP���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 lower chamber contains 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
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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Aminosyn II 5% in 25% Dextrose Injection, 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 5% in 25% Dextrose Injection is supplied in a
1000 mL volume dual-chamber flexible container (List No. 7744). Aminosyn II
5% in 25% Dextrose Injection is obtained by removing the divider clamp and
mixing the contents of the upper chamber, 500 mL of Aminosyn II 10%, with
the lower chamber, 500 mL of 50% Dextrose Injection. 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��to 8��C) co-polyester
(CR3) containers with care. Rev: May,
2004 ��Hospira 2004 EN-0131 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 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 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 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 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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dailymed-instance:genericMe... |
Isoleucine, Leucine, Lysine, Methionine, Phenylalanine,
Threonine, Tryptophan, Valine, Alanine, Arginine, Aspartic Acid, Glutamic
Acid, Glycine, Histidine, Proline, Serine, N-Acetyl-L-Tyrosine and Dextrose monohydrate
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Aminosyn II in 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 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 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 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. (This solution
(Aminosyn II 5% in 25% Dextrose Injection) 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 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 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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