Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2008
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Aminosyn II with Electrolytes in Dextrose with Calcium (Injection, Solution)
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| dailymed-instance:dosage |
The total daily dose of Aminosyn II with Electrolytes in
Dextrose Injection with Calcium 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 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 daily determinationof nitrogen balance and accurate body weights, corrected for fluid balance,
are probably the best means of assessing individual protein requirements.
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 with Electrolytesin Dextrose Injection with
Calcium by means of a Y-connector located near the infusion site, using separate
flow controls for each solution. 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. 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 ormore 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. The infusion rate for central vein admixtures
of Aminosyn II with Electrolytes in Dextrose Injection with Calcium 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 hypoglycemiamay 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. All of the aforementioned electrolytes are contained
in the Aminosyn II with Electrolytes in Dextrose Injection with Calcium. Supplemental
electrolyte additives may be used at the clinician's discretion. Vitamins,
including folic acid and vitamin K, are required additives. Vitamin K(Phytonadione
Injection, USP) is given intramuscularly or added to the solution as desired.
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. In patients with hyperchloremic or
other metabolic acidosis, supplemental 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
Patients Pediatric requirements for parenteral
nutrition are constrained by the greater relative fluid requirements of the
child and greater caloric requirements per kilogram. These solutions are too
concentrated for use in infants, 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 basis and 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. 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 and remove solution container. 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: (Use Aseptic Technique) 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 with Electrolytes (an amino acid injection with electrolytes)���a sterile, nonpyrogenic solution for intravenous infusion. Formulations
are described below. Lower
Chamber: Contains 500 mL of Dextrose Injection with 5 mEq Calcium���a sterile, nonpyrogenic, hypertonic solution of Dextrose, USP in
water for injection with added Calcium Chloride, USP dihydrate. 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. The composition
of this admixture is described in the table below. The electrolyte content (in mg/100 mL) of each admixed
formulation (not including ions for pH adjustment) is listed as follows: Aminosyn
II 3.5% with Electrolytes in 25% Dextrose Injection with Calcium Aminosyn
II 4.25% with Electrolytes in 20% Dextrose Injection with Calcium Aminosyn
II 4.25% with Electrolytes in 25% Dextrose Injection with Calcium Sodium
chloride, 205 mg; potassium chloride, 22.4 mg; calcium chloride, dihydrate,
36.8 mg; magnesium chloride, hexahydrate, 51 mg; potassium phosphate, dibasic,
261 mg; and sodium hydrosulfite added, 30 mg. Sodium
Chloride, USP is chemically designated NaCl, a white, crystalline powder freely
soluble in water. Potassium Chloride, USP is chemically
designated KCl, a white granular powder freely soluble in water. Calcium
Chloride, USP (dihydrate) is chemically designated CaCl���2HO, deliquescent, white granules 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. 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 in contact with the container
ports can leach out certain of their chemical components in very small amounts
within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to
5 parts per million. However, the safety of the plastic has been confirmed
in tests in animals according to USP biological tests for plastic containers
as well as by tissue culture toxicity studies.
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Aminosyn II with Electrolytes in Dextrose Injection with
Calcium, 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 admixture 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. These
solutions are too concentrated for use in infants.
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The Nutrimix dual-chamber flexible
container provides 500 mL of Aminosyn II with Electrolytes in the upper chamber
and 500 mL of Dextrose Injection with 5 mEq Calcium 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. Store at 20 to 25��C (68
to 77��F). [See USP Controlled Room Temperature.] Avoid exposure to light. To prevent breakage, handle cold or refrigerated (2��C
to 8��C) co-polyester (CR3) containers with care. Rev: October, 2004 ��Hospira 2004 EN-0693 Printed in
USA HOSPIRA, INC., LAKE
FOREST, IL 60045 USA
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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. Aminosyn
II with Electrolytes in 20% or 25% Dextrose Injection with Calcium are 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).<br/>Pregnancy Category C.: Animal reproduction studies have not been conducted with
Aminosyn II with Electrolytes in Dextrose Injection with Calcium. It is not
known whether this admixture can cause fetal harm when administered to a pregnant
woman or can affect reproductive capacity. Aminosyn II with Electrolytes in
Dextrose Injection with Calcium should be given to pregnant women only if
clearly needed. Not for use in infants. See CONTRAINDICATIONS and DOSAGE AND
ADMINISTRATION.<br/>Geriatric Use: Clinical studies of Aminosyn II with Electrolytes in Dextrose
Injection with Calcium have not been performed to determine whether patients
over 65 years 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 elderly patients 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 the risk of toxic
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
functions. 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, triglycerides, 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. This product contains no more than 25 mcg/L
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, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, aspartic acid, glutamic acid, histidine, proline, serine, tyrosine, glycine, dextrose monohydrate, sodium chloride, potassium chloride, calcium chloride, magnesium chloride and potassium phosphate, dibasic
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Aminosyn II with Electrolytes in Dextrose with Calcium (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. Also see WARNINGS and PRECAUTIONS. 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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Solutions of Aminosyn II in dextrose with a final concentration
of 20% or 25% are 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 with Electrolytes
in Dextrose Injection with Calcium 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. Admixtures of
Aminosyn II with Electrolytes 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 with Electrolytes in Dextrose Injection with
Calcium 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
trace metal additives and multivitamin additives will be in accordance with
the prescription of the attending physician.
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Aminosyn II with Electrolytes in Dextrose with Calcium
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