Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2710
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Aminosyn II in Dextrose (Injection, Solution)
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The total daily dose of Aminosyn II 3.5% M or 4.25% M in
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 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 thedaily 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% M or 4.25%
M in Dextrose Injection by means of a Y-connector located near the infusion
site, using separate flow controls for each solution. Aminosyn II 3.5% M or
4.25% M in Dextrose Injection may be premixed with fat emulsion, but only
in the 2000 mL Nutrimix II container. 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. Adult
Patients 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 takeninto 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. The
infusion rate for central vein admixtures of Aminosyn II 4.25% M in 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 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, phosphorus,
magnesium and calcium. With the exception of calcium, all of the aforementioned
electrolytes are contained in the Aminosyn II 3.5% M or 4.25% M. A calcium
supplement is recommended for central vein nutritional admixtures. 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. 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. 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.<br/>Pediatric: Due to their concentration, these solutions are not recommended
for use in pediatric patients less than 1 year old. Pediatric requirements
for parenteral nutrition are constrained by the greater relative fluid requirements
of the infant and greater caloric requirements per kilogram. Pediatric patients
greater than 1 year old generally receive a 2 to 2.5% amino acid solution,
but older pediatric patients can tolerate amino acids in concentrations of
up to 5%. Dosage is usually prescribed on a g/kg body weight/day basisand
patient age as follows: 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 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.<br/>Drug Interactions: Additives may be incompatible. Consult with pharmacist, if
available. When introducing additives, use aseptic technique, mix thoroughly
and do not store.
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Upper Chamber: Contains
500 mL of Aminosyn II 3.5% M or 4.25% M (an amino acid injection with maintenance
electrolytes)���a sterile, nonpyrogenic solution for intravenous infusion.
Formulations are described below. Lower
Chamber: Contains 500 mL of 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. 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. After admixture, the formulation contains the following
added ingredients per 100 mL: Aminosyn II 3.5% M in
5% Dextrose Injection Aminosyn II 4.25% M in 10% Dextrose
Injection Sodium chloride, 120 mg; potassium chloride,
97 mg; magnesium chloride (hexahydrate), 30 mg; dibasic sodium phosphate (anhydrous),
49.3 mg; and sodium hydrosulfite added, 30 mg. Sodium
Chloride, USP is chemically designated NaCl, a white crystalline compound
freely soluble in water. Potassium Chloride, USP is
chemically designated KCl, a white granular powder freely soluble in water. Magnesium
Chloride, USP (hexahydrate) is chemically designated MgCl���6HO, deliquescent crystals very soluble in water. Dibasic
Potassium Phosphate, USP (anhydrous) is chemically designated KHPO,
white granules very soluble in water. Dibasic Sodium
Phosphate, USP (anhydrous) is chemically designated NaHPO,
colorless or white granular salt freely soluble in water. Dextrose,
USP is chemically designated D-glucose, monohydrate (CHO���HO), a hexose sugar freely soluble in water. The
formulas for the individual amino acids are as follows: 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 accordingto USP biological standards
for plastic containers.
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Aminosyn II 3.5% M or 4.25% M in 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 or peripheral venous
line should be considered to approximate the protein and calorie requirements
for patients receivingtotal 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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The Nutrimix dual-chamber flexible container
provides 500 mL of Aminosyn II 3.5% M or 4.25% M in the upper chamber and
500 mL of Dextrose Injection, USP in the lower chamber. Concentrations provided
in the separate chambers and in the combined 1000 mL volume after release
of the clamp and mixing are shown below. 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. 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 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).<br/>Pregnancy Category C.: Animal reproduction studies have not been conducted with
Aminosyn II with maintenance electrolytes in 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% M or
4.25% M in Dextrose Injection should be given to pregnant women only if clearly
needed.<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.<br/>Geriatric Use: Clinical Studies of Aminosyn II 3.5% M or 4.25% M 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. 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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Special care must be taken when administering 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.
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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, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, Aspartic Acid, Glutamic Acid, histidine, proline, serine, tyrosine, glycine, dextrose, sodium chloride, potassium chloride, magnesium chloride, sodium phosphate and dextrose
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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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Aminosyn II 4.25% M in 10% Dextrose Injection is hypertonic,
but it may be delivered by peripheral vein only if lipid emulsion is administered
simultaneously. 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. Solutions of Aminosyn
II 3.5% M or 4.25% M in Dextrose Injection contain 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. (Admixtures
of Aminosyn II 3.5% M or 4.25% M in Dextrose Injection with an amino acid
concentration greater than 2.5% are 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 3.5% M or 4.25% M in Dextrose Injection is indicated
for intravenous 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 such as trace metal additives, or multivitamin
additives will be in accordance with the prescription of the attending physician.
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Aminosyn II in Dextrose
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