Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1329
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Aminosyn (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. Adults Admixtures
of 3.5 to 4.25% amino acids with 5 to 10% glucose may be coinfused with a
fat emulsion by peripheral vein to provide approximately 1400 to 2000 kcal/day.
Fat emulsion coadministration 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 total parenteral nutrition. Aminosyn
7% or 8.5% WITH ELECTROLYTES 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
separately to provide part of the calories, if desired. 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 be 20 to 25 grams
or more. Aminosyn 7% and 8.5% WITH ELECTROLYTES are
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 7% and 8.5% WITH
ELECTROLYTES do 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, phosphorus, 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 bottle, and the other to the bottle
of concentrated dextrose, and if the contents of both bottles are swirled
before they are combined, then the likelihood ofphysical 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 7% or 8.5% solution is used in equal volume
with 50% dextrose to provide an admixture containing 3.5% or 4.25% amino acids
and 25% dextrose. 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 WITH ELECTROLYTES,
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 7% or 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 to 130 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 bottles 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 WITH ELECTROLYTES, Sulfite-Free,
(a crystalline amino acid solution with electrolytes) is a sterile, nonpyrogenic
solution for intravenous infusion. Aminosyn WITH ELECTROLYTES is oxygen sensitive.
Three different formulations are available. The formulas for the individual amino acids present in
Aminosyn 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 WITH ELECTROLYTES, Sulfite-Free, (a crystalline
amino acid solution with electrolytes) provides crystalline amino acids to
promote protein synthesis and wound healing, and to reduce the rate of endogenous
protein catabolism. Aminosyn 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 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 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. It is recommended that the product
be stored at room temperature (25��C). Avoid
exposure to light. Rev: September, 2004 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 intravenouscatheter with the tip located in the superior vena
cava. SPECIAL PRECAUTIONS FOR CENTRAL
VENOUS INFUSIONS ADMINISTRATION BY CENTRAL
VENOUS CATHETER SHOULD BE USED ONLY BY THOSE FAMILIAR
WITH THIS TECHNIQUE AND ITS COMPLICATIONS. Central vein infusion (with added concentrated carbohydrate
solutions) of amino acid 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 (consult current medical literature).<br/>Pregnancy Category C: Animal reproduction studies have not been conducted with
Aminosyn WITH ELECTROLYTES, Sulfite-Free, (a crystalline amino acid solution
with electrolytes). It is not known whether Aminosyn WITH ELECTROLYTES, can
cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. Aminosyn WITH ELECTROLYTES, should be given to a pregnant woman
only if clearly needed.<br/>Geriatric Use: Clinical studies of Aminosyn WITH ELECTROLYTES, 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 peripheral 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. Aminosyn WITH ELECTROLYTES
contains no more than 25 mcg/L of aluminum.<br/>Drug Interactions: Because of its antianabolic activity, concurrent administration
of tetracycline may reduce the potential anabolic effects of amino acids infused
with dextrose as part of a parenteral feeding regimen. 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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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,
histidine, proline, serine, tyrosine, glycine, magnesium acetate, phosphoric acid, sodium chloride, and potassium acetate
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Aminosyn (Injection, Solution)
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Peripheral Infusions Aminosyn
3.5% M* Sulfite-Free, (a crystalline amino acid solution* with maintenance
electrolytes) is 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. Irritating additive medications
may need to be injected 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 limits
and continue to rise. It should be noted that a modest rise in BUN normally
occurs asa 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 WITH
ELECTROLYTES, Sulfite-Free, (a crystalline amino acid solution with electrolytes)
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. Aminosyn WITH ELECTROLYTES can be infused
simultaneously with fat emulsion by means of a Y-connector located near the
infusion site using separate flow rate controls for each solution. 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 WITH ELECTROLYTES, Sulfite-Free, (a crystalline
amino acid solution with electrolytes) infused with dextrose by peripheral
vein infusion is indicated as a source of nitrogen in the nutritional support
of patients with adequate stores of body fat, in whom, for short periods of
time, oral nutrition cannot be tolerated, is undesirable, or inadequate. Aminosyn
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 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
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