Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/560
Predicate | Object |
---|---|
rdf:type | |
rdfs:label |
Aminosyn (Injection, Solution)
|
dailymed-instance:dosage |
Aminosyn-HBC 7%, Sulfite-Free, (an amino acid injection���high branched chain) is administered intravenously. The total dose 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, is probably the best means of assessing individual protein
requirements. While Recommended Dietary Allowances for
oral protein are approximately 0.8 g/kg of body weight for the healthy adult,
protein and caloric requirements in traumatized or malnourished patients may
be substantially increased. To satisfy protein needs and promote positive
nitrogen balance, the daily dosage level of amino acids for adult patients
with adequate caloric intake is approximately 1.5 g/kg of body weight. Severely
catabolic states may require higher dosage levels. Such higher doses must
be accompanied by frequent laboratory evaluation. Fat emulsion may be administered
to help meet energy requirements. Fat emulsion coadministration 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 patientsmaintained on fat-free total parenteral
nutrition. For optimum amino acid utilization, sufficient
intracellular electrolytes (sodium, magnesium, and phosphate) should be provided.
Approximately 60 to 180 mEq of potassium, 10 to 30 mEq of magnesium, and 10
to 40 mM of phosphate/day appear necessary to achieve optimum metabolic response.
In addition, sufficient quantities of the major extracellular electrolytes
(sodium, calcium and chloride) must be given. In patients with hyperchloremicor other metabolic acidoses, sodium and potassium may be added as the acetate
or lactate salts to provide bicarbonate precursors. The electrolyte content
of Aminosyn-HBC 7% must be considered when calculating daily electrolyte intake.
Serum electrolytes, including magnesium and phosphorus, should be monitored
frequently. If a patient's nutritional intake is primarily parenteral, trace
metals and vitamins, especially the water-soluble vitamins, should also be
provided. Central Venous Nutrition: For severely catabolic, depleted patients or those who require
long-term parenteral nutrition, central venous nutrition should be considered.
Total parenteral nutrition may be started with admixtures containing lower
concentrations of dextrose; dextrose concentrations may be gradually increased
to approximate estimated energy requirements as the patient's glucose
tolerance increases. In adults, strongly hypertonic
admixtures of amino acids and dextrose may be safely administered only by
continuous infusion through a central venous catheter with the tip located
in the superior vena cava. A mixture containing 500 mL of Aminosyn-HBC 7%
with 500 mL of concentrated dextrose supplemented with electrolytes, trace
metals and vitamins may be administered over a period of approximately 8 hours.
If prescribed administration rates should fall behind schedule, no attemptto���catch up���to planned intake should be made. In addition
to meeting protein requirements, the administration is also governed by the
patient's glucose tolerance, especially during the first few days of
therapy. The daily intake of the amino acid/dextrose admixture should be increased
gradually to the maximum required dose, based on serial determinations of
urine and blood sugar levels. To prevent hyperglycemia and glycosuria, certain
patients may require exogenous insulin in order to receive adequate calories
from hypertonic dextrose. To prevent rebound hypoglycemia, a solution containing
5% dextrose should be administered when hypertonic dextrose infusions are
abruptly discontinued. Peripheral
Parenteral Nutrition: For the moderately catabolic, depleted patient
in whom aggressive central venous nutrition is not necessary, Aminosyn-HBC
7% may be given by peripheral vein with hypocaloric energy supplements. Dextrose
in a final concentration of up to 10% and/or lipid emulsion may be administered. Fat
provides approximately 9 kcal/gram and in long-term therapy (more than 5-7
days) will prevent essential fatty acid deficiency. Parenteral fat emulsion
may be administered simultaneously with amino acid-dextrose admixtures via
a Y-type administration set to supplement caloric intake. Fat, however, should
not provide more than 60% of the total caloric intake. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. WARNING: Do not use flexible container in series
connections.
|
dailymed-instance:descripti... |
Aminosyn-HBC 7%, Sulfite-Free, (an amino
acid injection high branched chain) is a sterile, nonpyrogenic, hypertonic
solution for intravenous infusion. Aminosyn-HBC 7% is oxygen sensitive. The
solution contains the following crystalline amino acids: The formulas for the individual amino acids present in
Aminosyn-HBC 7% 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.
|
dailymed-instance:clinicalP... |
Aminosyn-HBC 7%, Sulfite-Free, (an amino acid injection���high branched chain) provides a mixture of biologically utilizable essential
and nonessential crystalline amino acids in concentrated form for protein
synthesis. The solution contains a high (45%) concentration of the branched
chain amino acids (isoleucine, leucine and valine) relative to other general
purpose amino acid injections. Aminosyn-HBC 7%, when mixed with a concentrated
source of calories such as hypertonic dextrose, supplemented with appropriate
electrolytes, vitamins and trace metals and infused by central vein with or
without fat emulsion, provides total parenteral nutrition (TPN) for the severely
compromised patient. Aminosyn-HBC 7% may also be administered
peripherally with minimal caloric supplementation in order to conserve lean
body mass in the well-nourished, mildly catabolic patient. A
high concentration of the branched chain amino acids is present in Aminosyn-HBC
7% because these amino acids have been reported to be metabolically active
in the compromised patient. The acetate content of the
solution, under conditions of parenteral nutrition, would not be expected
to affect acid-base status adversely when renal and respiratory functions
are normal; confirmatory clinical/experimental evidence is not available.
The amount of sodium present is not clinically significant. The concentration
of chloride present is typical for TPN regimens.
|
dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
Aminosyn-HBC 7%, Sulfite-Free, (an amino acid injection���high branched chain) is contraindicated in patients with anuria, hepatic coma,
inborn errors of amino acid metabolism (especially those involving branched
chain amino acid metabolism such as Maple Syrup Urine Disease and Isovaleric
Acidemia), severe or uncorrected electrolyte or acid-base imbalance, hyperammonemia
or other disorders involving impaired nitrogen utilization, or hypersensitivity
to one or more amino acids present in the solution.
|
dailymed-instance:supply |
Aminosyn-HBC 7%, Sulfite-Free, (an amino acid injection���high branched chain) is supplied in 500 and 1000 mL single-dose containers
(List No. 4168). 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. HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
|
dailymed-instance:boxedWarn... |
SPECIAL PRECAUTIONS FOR CENTRAL INFUSIONS ADMINISTRATION
BY CENTRAL VENOUS CATHETER SHOULD BE USED ONLY BY THOSE
FAMILIAR WITH THIS TECHNIQUE AND ITS COMPLICATIONS.
|
dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
Special care must be taken when administering hypertonic
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. 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. 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. Aminosyn-HBC
7%, Sulfite -Free, (an amino acid injection���high branched chain)
contains no added phosphorus. Patients, especially those with hypophosphatemia,
may require the addition of phosphate. To prevent hypocalcemia, calcium supplementation
should always accompany phosphate administration. To assure adequate intake,
serum levels should be monitored frequently. 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. Aminosyn-HBC contains no more than 25 mcg/L of
aluminum. 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 (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 (See also Current Medical Literature).<br/>Pregnancy:: Teratogenic effects. Pregnancy Category
C: Animal reproduction studies have not been performed with Aminosyn-HBC 7%.
It is not known whether Aminosyn-HBC 7% can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. Aminosyn-HBC 7% should
be given to a pregnant woman only if clearly needed.<br/>Pediatric Use:: Safety and effectiveness in children have not been established.<br/>Geriatric Use:: Clinical studies of Aminosyn-HBC 7% did not include sufficient
numbers of subjects aged 65 and over to determine whether they respond differently
from younger subjects. Other reported clinical experience has not identified
differences in responses between the elderly and younger patients. In general,
dose selection for an elderly patient should be cautious, usually starting
at the low end ofthe dosage range, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease or other drug
therapy.<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.
|
dailymed-instance:overdosag... |
In the event of fluid, electrolyte or metabolic imbalances
re-evaluate the patient and institute appropriate corrective measures; see
WARNINGS and PRECAUTIONS.
|
dailymed-instance:genericMe... |
Isoleucine, leucine, lysine acetate, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, histidine, proline, serine, tyrosine and glycine
|
dailymed-instance:fullName |
Aminosyn (Injection, Solution)
|
dailymed-instance:adverseRe... |
See WARNINGS and SPECIAL PRECAUTIONS FOR CENTRAL VENOUS NUTRITION. Reactions
secondary to the administration technique or the solution include febrile
response, infection at the injection site, venous thrombosis or phlebitis
extending from the site of injection, extravasation, and hypervolemia. Local
reactions at the infusion site, consisting of a warm sensation, erythema,
phlebitis and thrombosis have been reported with peripherally administered
amino acid solutions, especially if other substances are also administered
through the same site. Generalized flushing, fever and
nausea have been reported during peripheral administration of amino acids. Symptoms
may result from an excess or deficit of one or more of the ions present in
the solution; therefore, frequent monitoring of electrolyte levels is essential. If
electrolyte supplements are required during peripheral infusions, it is recommended
that additives be administered throughout the day in order to avoid possible
vein irritation. Irritating additive medications may require injection at
another site and should not be added directly to the amino acid infusate. Phosphorus
deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia.
Relative to calcium, excessive phosphorus intake can precipitate hypocalcemia
with cramps, tetany and muscular hyperexcitability. 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.
|
dailymed-instance:warning |
Safe, effective use of parenteral nutrition requires a knowledge
of nutrition as well as clinical expertise in recognition and treatment of
the complications which can occur. Frequent evaluation
and laboratory determinations are necessary for proper monitoring of parenteral
nutrition. Studies should include blood sugar, serum proteins, kidney
and liver function tests, electrolytes, hemogram, carbon dioxide content,
serum osmolarities, blood cultures, and blood ammonia levels. Administration
of amino acids in the presence of impaired renal function or gastrointestinal
bleeding may augment an already elevated blood urea nitrogen. Patients with
azotemia from any cause should not be infused with amino acids without regard
to total nitrogen intake. Administration of amino acid
solutions that have not been specifically formulated to treat patients with
hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia,
prerenal azotemia, stupor and coma. Conservative doses
of amino acids should be given, dictated by the nutritional status of the
patient. Should symptoms of hyperammonemia develop, amino acid administration
should be discontinued and the patient's clinical status re-evaluated. Administration
of intravenous solutions can cause fluid and/or solute overload resulting
in dilution of serum electrolyte concentrations, overhydration, congested
states, or pulmonary edema. The risk of dilutional states is inversely proportional
to the electrolyte concentrations of the solutions. The risk of solute overload
causing congested states with peripheral and pulmonary edema is directly proportional
to the electrolyte concentrations of the solutions. 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.
|
dailymed-instance:indicatio... |
Parenteral nutrition with Aminosyn-HBC 7%, Sulfite-Free,
(an amino acid injection���high branched chain) is indicated to prevent
nitrogen loss or treat negative nitrogen balance in adults where (1) the alimentary
tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not
be used, or adequate protein intake is not feasible by these routes; (2) gastrointestinal
absorption of protein is impaired; or (3) nitrogen homeostasis is substantially
impaired as with severe trauma or sepsis. Dosage, route of administration
and concomitant infusion of nonprotein calories are dependent on various factors,
such as nutritional and metabolic status of thepatient, anticipated duration
of parenteral nutrition support, and vein tolerance. See DOSAGE AND ADMINISTRATION
for additional information. Central
Venous Nutrition: Central venous infusion should be considered when
amino acid solutions are to be admixed with hypertonic dextrose to promote
protein synthesis in hypercatabolic or severely depleted patients, or those
requiring long-term parenteral nutrition. See SPECIAL PRECAUTIONS FOR CENTRAL
INFUSIONS. Peripheral Parenteral
Nutrition: For moderately catabolic or depleted patients in whom
the central venous route is not indicated, diluted amino acid solutions with
minimal caloric supplementation may be infused by peripheral vein, supplemented,
if desired, with fat emulsion.
|
dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Aminosyn
|