Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/902
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Aminosyn II with Electrolytes (Injection, Solution)
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The total daily dose of the solution depends on the daily
protein 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. Parenteral drug products should be inspected
visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. Central
Vein Total Parenteral Nutrition For central
vein infusion with concentrated dextrose solution, alone or with I.V. lipid,the total daily dose of the amino acid solution depends upon daily protein
requirements and the patient's metabolic and clinical response. The
determination of nitrogen balance and accurate daily body weights, corrected
for fluid balance, are probably the best means of assessing individual protein
requirements. Adults Admixtures
of 3.5 to 4.25% amino acids with 5 to 10% dextrose may be infused with a fat
emulsion by peripheral vein to provide approximately 1400 to 2000 kcal/day.
Fat emulsion administration should be considered when prolonged parenteral
nutrition is required in order to prevent essential fatty acid deficiency
(E.F.A.D.). Serum lipids should be monitored for evidence of E.F.A.D.in patients
maintained on fat-free TPN. Aminosyn II 8.5% WITH ELECTROLYTES,
Sulfite-Free, (an amino acid injection) should only be infused via a central
vein when admixed with sufficient dextrose to provide full caloric requirements
in patients who require prolonged total parenteral nutrition. I.V. lipid may
be administered to provide part of the calories, if desired. Serum lipids
should be monitored for evidence of essential fatty acid deficiency in patients
maintained on fat-free TPN. Total parenteral nutrition
(TPN) may be started with 10% dextrose added to the calculated daily requirement
of amino acids (1.5 g/kg for a metabolically stable patient). Dextrose content
is gradually increased over the next few days to the estimated daily caloric
need as the patient adapts to the increasing amounts of dextrose. Each gram
of dextrose provides approximately 3.4 kcal. Each gram of fat provides 9 kcal. The
average depleted major surgical patient with complications requires between
2500 and 4000 kcal and between 12 and 24 grams of nitrogen per day. An adult
patient in an acceptable weight range with restricted activity who is not
hypermetabolic, requires about 30 kcal/kg of body weight/day. Average daily
adult fluid requirements are between 2500 and 3000 mL and may be much higher
with losses from fistula drainage or in severe burns. Typically, a hospitalized
patient may lose 12 to 18 grams of nitrogen a day, and in severe trauma the
daily loss may be20 to 25 grams or more. Aminosyn
II 8.5% WITH ELECTROLYTES is designed to supply necessary electrolytes to
patients in a stable metabolic state (about three-fourths of all patients
on total parenteral nutrition). Other patients may require more or less of
the electrolytes present, e.g., cardiac patients who should not receive sodium.
Aminosyn II 8.5% WITH ELECTROLYTES does not contain calcium, and this should
be added as indicated. 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, phosphate,
magnesium and calcium. 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 phosphorus 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 phosphorus additives are potentially
incompatible when added to the TPN admixture. However, if one additive is
added to the amino acid container, and the other to the container of concentrated
dextrose, and if the contents of both containers are swirled 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. Typically, the 8.5% solution is used in equal volume with
50% or 70% dextrose to provide an admixture containing 4.25% amino acids and
25% or 35% dextrose respectively. The rate of intravenous
infusion initially should be 2 mL/min and may be increased gradually. If administration
should fall behind schedule, no attempt to���catch up���to planned
intake should be made. In addition to meeting protein needs, the rate of administration
is governed by the patient's glucose tolerance estimated by glucose
levels in blood and urine. Aminosyn II 8.5% WITH ELECTROLYTES
solution, when mixed with an appropriate volume of concentrated dextrose,
offers a higher concentration of calories and nitrogen per unit volume. This
solution is indicated for patients requiring larger amounts of nitrogen than
could otherwise be provided or where total fluid load must be kept to a minimum,
for example, patients with renal failure. Provision
of adequate calories in the form of hypertonic dextrose may require exogenous
insulin to prevent hyperglycemia and glycosuria. To prevent rebound hypoglycemia,
do not abruptly discontinue administration of nutritional solutions. Pediatric Aminosyn II 8.5%
WITH ELECTROLYTES may not be suitable for use in infants whose electrolyte
requirements must be���custom tailored���based on serial blood
chemistry determinations. Pediatric requirements for
parenteral nutrition are constrained by the greater relative fluid requirements
of the infant and greater caloric requirements per kilogram. Amino acids are
probably best administered in a 2.5% concentration. For most pediatric patients
on intravenous nutrition, 2.5 grams amino acids/kg/day with dextrose
alone or with I.V. lipid calories of 100 to130 kcal/kg/day is recommended.
In cases of malnutrition or stress, these requirements may be increased. It
is acceptable in pediatrics to start with a nutritional solution of half strength
at a rate of about 60 to 70 mL/kg/day. Within 24 to 48 hours the volume and
concentration of the solution can be increased until the full strength pediatric
solution (amino acids and dextrose) is given at a rate of 125 to 150 mL/kg/day. Supplemental
electrolytes and vitamin additives should be administered as deemed necessary
by careful monitoring of blood chemistries and nutritional status. Addition
of iron is more critical in the infant than the adult because of the increasing
red cell mass required for the growing infant. 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 infants, accurately calibrated and reliable infusion
systems should be used. A basic solution for pediatric
use should contain 25 grams of amino acids and 200 to 250 grams of glucose
per 1000 mL, administered from containers containing 250 or 500 mL. Such a
solution given at the rate of 145 mL/kg/day provides 130 kcal/kg/day. WARNING: Do not use flexible container in series
connections.
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Aminosyn' II 8.5% WITH ELECTROLYTES, Sulfite-Free, (an
amino acid injection with electrolytes) is a sterile, nonpyrogenic solution
for intravenous infusion. Aminosyn II 8.5% WITH ELECTROLYTES is oxygen sensitive.
The following formulation is available: The formulas for the individual amino acids present in
Aminosyn II 8.5% WITH ELECTROLYTES are as follows: The flexible plastic container is fabricated from a specially
formulated polyvinylchloride. 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 plastic container may leach out certain chemical components
from the plastic in very small amounts; however, biological testing was supportive
of the safety of the plastic container materials. Exposure
to temperatures above 25��C/77��F during transport and storage will
lead to minor losses in moisture content. Higher temperatures lead to greater
losses. It is unlikely that these minor losses will lead to clinically significant
changes within the expiration period.
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Aminosyn II 8.5% WITH ELECTROLYTES, Sulfite-Free, (an amino
acid injection with electrolytes) provides crystalline amino acids to promote
protein synthesis and wound healing, and to reduce the rate of endogenous
protein catabolism. Aminosyn II 8.5% WITH ELECTROLYTES, given by central venous
infusion in combination with concentrated dextrose, electrolytes, vitamins,
trace metals, and ancillary fat supplements, constitutes total parenteral
nutrition (TPN). Aminosyn II 8.5% WITH ELECTROLYTES can also be administered
by peripheral vein with dextrose and maintenance electrolytes. Intravenous
fat emulsion may be substituted for part of the carbohydrate calories during
either TPN or peripheral vein administration of Aminosyn II 8.5% WITH ELECTROLYTES.
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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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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. HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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SPECIAL PRECAUTIONS FOR CENTRAL
VENOUS 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 glucose to
provide calories in diabetic or prediabetic patients. 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. The effect
of infusion of amino acids, without dextrose, upon carbohydrate metabolism
of children is not known at this time. Nitrogen intake
should be carefully monitored in patients with impaired renal function. For
long-term total nutrition, or if a patient has inadequate fat stores, it is
essential to provide adequate exogenous calories concurrently with the amino
acids. Concentrated dextrose solutions are an effective source of such calories.
Such strongly hypertonic nutrient solutions should be administered through
an indwelling intravenous catheter with the tip located in the superior vena
cava.
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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, alanine, arginine, Aspartic Acid, Glutamic Acid, histidine, proline, serine, tyrosine, glycine, valine, sodium choride, magnesium chloride, sodium phosphate dibasic and potassium chloride
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Aminosyn II with Electrolytes (Injection, Solution)
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Peripheral Infusions A
3.5% to 5% solution of amino acids (without additives) is slightly hypertonic.
Local reactions consisting of a warm sensation, erythema, phlebitis and thrombosis
at the infusion site have occurred with peripheral intravenous infusion of
amino acids particularly if other substances, such as antibiotics, are also
administered through the same site. In such cases the infusion site should
be changed promptly to another vein. Use of large peripheral veins, inline
filters, and slowing the rate of infusion may reduce the incidence of local
venous irritation. Electrolyte additives should be spread throughout the day.Irritating additive medications may need to be infused at another venous site. Generalized
flushing, fever and nausea also have been reported during peripheral infusions
of amino acid solutions.
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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 limitsand 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
which contain potassium ion 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 8.5%
WITH ELECTROLYTES, Sulfite-Free, (an amino acid injection) may not be suitable
for use in infants who require individualized electrolyte therapy. Hyperammonemia
is of special significance in infants, as it can result in mental retardation.
Therefore, it is essential that blood ammonia levels be measured frequently
in 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 8.5% WITH ELECTROLYTES, Sulfite-Free, (an amino
acid injection) infused with dextrose by peripheral vein infusion is indicated
as a source of nitrogen in the nutritional support of patients in whom, for
short periods of time, oral nutrition cannot be tolerated, is undesirable,
or inadequate. Aminosyn II 8.5% WITH ELECTROLYTES can
be administered peripherally with dilute (5 to 10%) dextrose solution and
I.V. fat emulsion as a source of nutritional support. This form of nutritional
support can help to preserve protein and reduce catabolism in stress conditions
where oral intake is inadequate. When administered with
concentrated dextrose solution with or without fat emulsions, Aminosyn II
8.5% WITH ELECTROLYTES is also indicated for central vein infusion to prevent
or reverse negative nitrogen balance in patients where: (a) the alimentary
tract, by the oral, gastrostomy or jejunostomy route cannot or should not
be used; (b) gastrointestinal absorption of protein is impaired; (c) metabolic
requirements for protein 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.
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Aminosyn II with Electrolytes
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