Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3198
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Aminosyn, Sulfite-Free (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 Diluted
solutions containing 3.5 to 5% 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. Aminosyn 10% (pH 6) solution 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 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
solutions without electrolytes are intended for patients requiring individualized
electrolyte therapy. Sodium, chloride, potassium, phosphate, calcium and magnesium
are major electrolytes which should be added to Aminosyn as required. 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 phosphate
added to a liter of TPN solution (containing 25% dextrose) is 12mM. 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 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 10% solution is used in equal volume with
50% dextrose to provide an admixture containing 5% 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
10% (pH 6) 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 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 requirementsmay 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 500 mL or less. 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 10% (pH 6), Sulfite-Free, (an amino
acid injection) is a sterile, nonpyrogenic solution for intravenous infusion.
Aminosyn 10% (pH 6) is oxygen sensitive. *Amount cited is for L-lysine alone and does not include
the acetate salt. Adjusted with acetic acid. The
formulas for the individual amino acids present in Aminosyn 10% (pH 6) 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 10% (pH 6), Sulfite-Free, (an amino acid injection)
provides amino acids to promote protein synthesis and wound healing, and to
reduce the rate of endogenous protein catabolism. Aminosyn 10% (pH 6), given
by central venous infusion in combination with concentrated dextrose, electrolytes,
vitamins, trace metals, and ancillary fat supplements, constitutes total parenteral
nutrition (TPN). Aminosyn 10% (pH 6) can also beadministered 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 10% (pH 6).
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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 until use. Rev: August,
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. Do
not withdraw venous blood for blood chemistries through the peripheral infusion
site, as interference with estimations of nitrogen containing substances may
occur. Intravenous 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. 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.) 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 10% (pH 6), Sulfite-Free, (an amino acid injection). It is not known
whether Aminosyn 10% (pH 6) can cause fetal harm when administered to a pregnant
woman or can affect reproduction capacity. Aminosyn 10% (pH 6) should
be given to a pregnant woman only if clearly needed.<br/>Geriatric Use: Clinical studies of Aminosyn 10% (pH 6) 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. 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 10% (pH 6) 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, and glycine
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Aminosyn, Sulfite-Free (Injection, Solution)
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Peripheral Infusions Aminosyn
10% (pH 6), Sulfite-Free, (an amino acid injection) is hypertonic and must
be diluted prior to administration by peripheral vein. 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. Simultaneous
administration of Aminosyn/dextrose admixtures with intravenous lipid emulsion
may reduce the likelihood of peripheral vein irritation. Electrolyte additives
should be spread throughout the day. 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 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. 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
10% (pH 6), Sulfite-Free, (an amino acid injection) 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 10% (pH 6), 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 with adequate stores of
body fat, in whom, for short periods of time, oral nutrition cannot be tolerated,
is undesirable, or inadequate. SUPPLEMENTAL ELECTROLYTES,
IN ACCORDANCE WITH THE PRESCRIPTION OF THE ATTENDING PHYSICIAN, MUST BE ADDED
TO AMINOSYN SOLUTIONS WITHOUT ELECTROLYTES. Aminosyn
10% (pH 6) can be administered peripherally with dilute (5% to 10%) dextrose
solution and I.V. fat emulsion as a source of nutritional support in patients
who, while not hypermetabolic, cannot be satisfactorily maintained on peripheral
intravenous nutrition. 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 solutions with or without fat emulsions,
Aminosyn 10% (pH 6) 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 maybe reduced by replacing amino acids
lost from tissue breakdown, thereby preserving tissue reserves, as in acute
renal failure.
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Aminosyn, Sulfite-Free
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