Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/66
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Aminosyn-HF (Injection, Solution)
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The objective of nutritional management of patients with
liver disease is the provision of sufficient amino acid and caloric support
for protein synthesis without exacerbating hepatic encephalopathy. The
total daily dose of Aminosyn-HF 8% (amino acid injection 8%) depends on daily
protein requirements and on 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. Dosage should also be guided by the patient's fluid intake
limits and glucose and nitrogen tolerances, as well as by metabolic and clinical
response. The recommended dosage is 80 to 120 g of amino
acids (12 to 18 g of nitrogen) as Aminosyn-HF 8% per day. Typically, 500 mL
of Aminosyn-HF 8% appropriately mixed with 500 mL of 50% dextrose supplemented
with electrolytes and vitamins is administered over an 8 to 12 hour period.
This results in a total daily fluid intake of approximately 2 to 3 liters.
Patients with fluid restrictions may only tolerate 1 to 2 liters. Although
nitrogen requirements may be higher in severely hypercatabolic ordepleted
patients, provision of additional nitrogen may not be possible due to fluid
intake limits, nitrogen, or glucose intolerance. 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 solutions are abruptly
discontinued. Fat emulsion co-administration should
be considered when prolonged (more than 5 days) 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.
Caution should be exercised in administering fat emulsions to patients with
severe liver damage. Fat emulsion may obscure the presence of precipitate
formation. The provision of sufficient intracellular
electrolytes, principally potassium, magnesium, and phosphate, is required
for optimum utilization of amino acids. Approximately 60 to 180 mEq of potassium,
10 to 30 mEq of magnesium, and 10 to 40 mMol of phosphorus per 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 hyperchloremic or other metabolic acidoses, sodium
and potassium may be added as the acetate salts to provide bicarbonate precursor.
The electrolyte content of Aminosyn-HF 8% must be considered when calculating
daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus,
should be monitored frequently. Hypertonic mixtures
of amino acid and dextrose may be safely administered by continuous infusion
through a central venous catheter with the tip located in the superior vena
cava. Initial infusion rates should be slow, and gradually increased to the
recommended 60 to 125 mL/hour. If the administration rate 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, particularly during
the first few days of therapy, is governed by the patient's glucose
tolerance. Daily intake of amino acids and dextrose should be increased gradually
to the maximum required dose as indicated by frequent determinations of glucose
levels in blood and urine. For patients in whom the
central venous route is not indicated and who can consume adequate calories
enterally, Aminosyn-HF 8% may be administered by peripheral vein with or without
parenteral carbohydrate calories. Such infusates can be prepared by dilutions
of Aminosyn-HF 8% with Sterile Water for Injection, USP or 5% to 10% dextrose
to prepare isotonic or slightly hypertonic solutions for peripheral infusion.
It is essential that peripheral infusion be accompanied by adequate caloric
supplementation. Parenteral drug products should be
inspected visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. Care must be
taken to avoid incompatible admixtures. Consult with pharmacist. WARNING: Do not use flexible container in series connections.
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| dailymed-instance:descripti... |
Aminosyn-HF 8% (amino acid injection 8%) is a sterile, nonpyrogenic,
hypertonic solution for intravenous infusion. The formulation is described
below: The formulas for the individual amino acids present in
Aminosyn���HF 8% 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 can leach out certain of its chemical
components in very small amounts within the expiration period, e.g., di-2-ethylhexyl
phthlate (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. 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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| dailymed-instance:clinicalP... |
Aminosyn-HF 8% (amino acid injection 8%) provides a mixture
of essential and nonessential amino acids with high concentrations of the
branched chain amino acids (isoleucine, leucine, and valine) and low concentrations
of methionine and the aromatic amino acids (phenylalanine and tryptophan)
relative to general purpose amino acid injections. This amino acid composition
has beenspecifically formulated to provide a well tolerated nitrogen source
for nutritional support and therapy of patients with liver disease who have
hepatic encephalopathy. The precise mechanisms which
produce the therapeutic effects of Aminosyn-HF 8% are not known. The etiopathology
of hepatic encephalopathy is also unknown and is thought to be of multifactorial
origin. The rationale for Aminosyn-HF 8% is based on observations of plasma
amino acid imbalances in patients with liver diseaseand on theories which
postulate that these abnormal patterns are causally related to the development
of hepatic encephalopathy. Clinical studies in patients
with hepatic encephalopathy showed that infusion of a solution identical to
Aminosyn-HF 8% reversed the abnormal plasma amino acid pattern characterized
by decreased levels of branched chain amino acids and elevated levels of aromatic
amino acids and methionine. The trend toward normalization of these amino
acids was generally associated with an improvement in mental status and EEG
patterns. This clinical response was observed in the majority of patients
studied. Nitrogen balance was significantly improved and mortality reduced
in these typically protein-intolerant patients who received substantial amounts
of protein equivalent from the amino acid solution. When
infused with hypertonic dextrose as a calorie source, supplemented with electrolytes,
vitamins, and minerals, Aminosyn-HF 8% provides total parenteral nutrition
in patients with liver disease, with the exception of essential fatty acids. Phosphate
is a major intracellular anion which participates in providing energy for
metabolism of substrates and contributes to significant metabolic and enzymatic
reactions in all organs and tissues. It exerts a modifying influence on calcium
levels, a buffering effect on acid-base equilibrium, and has a primary role
in the renal excretion of hydrogen ions. It is thought
that the acetate from lysine acetate and acetic acid, under the conditions
of parenteral nutrition, does not impact net acid-base balance when renal
and respiratory functions are normal. Clinical evidence seems to support this
thinking; however, confirmatory experimental evidence is not available. The
amounts of sodium and chloride present are not of clinical significance.
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Aminosyn-HF 8% (amino acid injection 8%) is contraindicated
in patients with anuria, inborn errors of amino acid metabolism, especially
those involving branched chain amino acid metabolism such as Maple Syrup Urine
Disease and Isovaleric Acidemia, or hypersensitivity to one or more amino
acids present in the solution.
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Aminosyn-HF 8% (amino acid injection 8%) is supplied in a
500 mL single-dose flexible plastic container List 4167. 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.] However, brief exposure up to 40��C does
not adversely affect the product. Avoid
exposure to light. HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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SPECIAL PRECAUTIONS FOR CENTRAL
VENOUS NUTRITION ADMINISTRATION BY CENTRAL
VENOUS CATHETER SHOULD BE USED ONLY BY THOSE FAMILIAR WITH THIS TECHNIQUE
AND ITS COMPLICATIONS.
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General: Clinical evaluation and periodic laboratory
determinations are necessary to monitor changes in fluid balance, electrolyte
concentrations, and acid-base balance during prolonged parenteral therapy
or whenever the condition of the patient warrants such evaluation. Significant
deviations from normal concentrations may require the use of additional electrolyte
supplements. Strongly hypertonic nutrient solutions
should be administered through an indwelling intravenous catheter with the
tip located in the superior vena cava. Special care
must be taken when giving hypertonic dextrose to a diabetic or prediabetic
patient. To prevent severe hyperglycemia in such patients, insulin may be
required. Peripheral intravenous administration of Aminosyn-HF
8% (amino acid injection 8%) requires appropriate dilution and provision of
adequate calories. Care should be taken to assure proper placement of the
needle within the lumen of the vein. The venipuncture site should be inspected
frequently for signs of infiltration. If venous thrombosis or phlebitis occurs,discontinue infusions or change infusion site and initiate appropriate treatment. Care
should be taken to avoid circulatory overload, particularly in patients with
cardiac insufficiency. In patients with myocardial infarct,
infusion of amino acids should always be accompanied by dextrose since in
anoxia, free fatty acids cannot be utilized by the myocardium, and energy
must be produced anaerobically from glycogen or glucose. Infusion
of Aminosyn-HF 8% may not affect the clinical course of patients with fulminant
hepatitis who have a poor prognosis and are generally unresponsive to treatment.
It has been shown that the abnormal plasma amino acid pattern in fulminant
hepatitis differs from that in chronic liver disease. Extraordinary
electrolyte losses such as may occur during protracted nasogastric suction,
vomiting, diarrhea, or gastrointestinal fistula drainage may necessitate additional
electrolyte supplementation. Administration of glucose
at a rate exceeding the patient's utilization rate may lead to hyperglycemia,
coma, and death. Metabolic acidosis can be prevented
or readily controlled by adding a portion of the cations in the electrolyte
mixture as acetate salts and in the case of hyperchloremic acidosis, by keeping
the total chloride content of the infusate to a minimum. Aminosyn-HF
8% contains no more than 25 mcg/L of aluminum. Aminosyn-HF
8% contains less than 3 mEq chloride per liter. Aminosyn-HF
8% contains 10 mMol of phosphate/liter. Some patients, especially those with
hypophosphatemia, may require additional phosphate. To prevent hypocalcemia,
calcium supplementation should always accompany phosphate administration.
To assure adequate intake, serum levels should be monitored frequently. Aminosyn-HF
8% has not been adequately studied in pregnant women and children; therefore,
its safe use in such patients has not been demonstrated. To
minimize the risk of possible incompatibilities arising from mixing this solution
with other additives that may be prescribed, the final infusate should be
inspected for cloudiness or precipitation immediately after mixing, prior
to administration, and periodically during administration. Use
only if solution is clear and container is undamaged. Must not be used in
series connections.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Studies with Aminosyn-HF 8% have not been performed to evaluate
carcinogenic potential, mutagenic potential, or effects on fertility.<br/>Pregnancy:: Teratogenic Effects: Pregnancy
Category C: Animal reproduction studies have not been conducted
with Aminosyn���HF 8%. It is also not known whether Aminosyn���HF
8% can cause fetal harm when administered to a pregnant woman or can affect
reproduction capacity. Aminosyn���HF 8% should be given to a pregnant
woman only if clearly needed.<br/>Nursing Mothers: Caution should be exercised when Aminosyn���HF 8% is
administered to a nursing woman.<br/>Pediatric Use: Safety and effectiveness in pediatric patients have not been
established.<br/>Geriatric Use: Clinical studies of Aminosyn���HF 8% 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 renalfunction. 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. SPECIAL PRECAUTIONS FOR CENTRAL
VENOUS NUTRITION ADMINISTRATION BY CENTRAL
VENOUS CATHETER SHOULD BE USED ONLY BY THOSE FAMILIAR WITH THIS TECHNIQUE
AND ITS COMPLICATIONS. Central venous nutrition may be associated with complications
which can be prevented or minimized by careful attention to all aspects of
the procedure, including 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. Although
a detailed discussion of the complications is beyond the scope of this insert,
the following summary lists those based on current literature.
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In the event of a fluid or solute overload during parenteral
therapy, re-evaluate the patient's condition and institute appropriate
corrective treatment. See WARNINGS and PRECAUTIONS.
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Isoleucine, leucine, lysine, methionine, phenylalanine, threonine, tryptophan, valine, alanine, arginine, glycine, histidine, proline, serine and cysteine hydrochloride
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Aminosyn-HF (Injection, Solution)
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| dailymed-instance:adverseRe... |
See WARNINGS and SPECIAL PRECAUTIONS FOR CENTRAL VENOUS NUTRITION. Reactions
reported in clinical studies as a result of infusion of the parenteral fluid
were water weight gain, edema, increase in BUN, and dilutional hyponatremia.
Asterixis was reported to have worsened in one patient during infusion of
the amino acid solution. 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. 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. 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. Ifan 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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Additives may be incompatible. Consult with pharmacist, if
available. When introducing additives, use aseptic techniques. Mix thoroughly.
Do not store. Because of the potential for life-threatening
events, caution should be taken to ensure that precipitates have not formed
in any parenteral nutrient admixture. This product contains
sodium hydrosulfite, a form of 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. Safe,
effective use of parenteral nutrition requires a knowledge of nutrition as
well as clinical expertise in recognition and treatment of the complicationswhich can occur. FREQUENT EVALUATIONS 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 intravenous solutions can cause fluid and/or solute overload resulting
in dilution of serum electrolyte concentrations, over-hydration, 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.
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| dailymed-instance:indicatio... |
Aminosyn-HF 8% (amino acid injection 8%) is indicated for
the treatment of hepatic encephalopathy in patients with cirrhosis or hepatitis.
Aminosyn-HF 8% provides nutritional support for patients with these diseases
of the liver who require parenteral nutrition and are intolerant of general
purpose amino acid injections, which are contraindicated in patients with
hepatic coma.
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Aminosyn-HF
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