Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/191
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Hepatasol (Injection)
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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 8% Hepatasol (Amino Acid) Injection 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 80-120 grams of amino acids (12-18 grams of nitrogen) as 8%
Hepatasol (Amino Acid) Injection per day. Typically, 500
mL of 8% Hepatasol (Amino Acid) Injection appropriately
mixed with 500 mL of 50% dextrose supplemented with electrolytes and
vitamins is administered over an 8-12 hour period. This results in a
total daily fluid intake of approximately 2-3 liters. Patients with
fluid restrictions may only tolerate 1-2 liters. Although nitrogen
requirements may be higher in severely hypercatabolic or depleted
patients, provision of additional nitrogen may not be possible due to
fluid intake limits, nitrogen, or glucose intolerance.<br/>Pediatric Use:: Use of 8%
Hepatasol (Amino Acid) Injection in pediatric patients is governed by the same considerations that affect the
use of any amino acid solution in pediatrics. The amount
administered is dosed on the basis of grams of amino acids/kg of
body weight/day. Two to three g/kg of body weight for infants
with adequate calories are generally sufficient to satisfy
protein needsand promote positive nitrogen balance. Solutions
administered by peripheral vein should not exceed twice normal
serum osmolarity (718 m0smol/L). 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 coadministration should be considered when prolonged
(more than 5 days) 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. 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 60-160 mEq of
potassium, 10-30 mEq of magnesium, and 10-40 mmoles of phosphate
per day appear necessary to achieve optimum metabolic response.
In addition, sufficient quantitiesof 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 8%
Hepatasol (Amino Acid) Injection must be
considered when calculating daily electrolyte intake. Serum
electrolytes, including magnesium and phosphorus, should be monitored frequently. 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 superior vena cava. Initial infusion
rates should be slow, and gradually increased to the recommended
60-125 mL/hr. If 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 firstfew 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, 8%
Hepatasol (Amino Acid) Injection may be administered
by peripheral vein with or without parenteral carbohydrate
calories. Such infusates can be prepared by dilution of 8%
Hepatasol (Amino Acid) Injection with Sterile
Water for Injection or 5%-10% dextrose to prepare isotonic or slightly hypertonic solutions for peripheral infusion. It is
essential that peripheral infusion be accompanied by adequate
caloric supplementation. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718
mOsmol/L). 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.
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8%
Hepatasol (Amino Acid) Injection is a sterile, nonpyrogenic,
hypertonic solution containing crystalline amino acids. Each 100 mL
contains: Essential Amino Acids Nonessential Amino Acids Electrolyte profile mEq per liter* Sodium 10, Chloride
less than 3, Phosphate (as HPO=) 20 (10 mmoles/Liter),
Acetate 63 (provided as glacial acetic acid and lysine acetate). 0.1 g/100 mL (10
mEq/L) sodium bisulfite added as stabilizer.
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8%
Hepatasol (Amino Acid) Injection 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 been specifically formulated to provide a
well tolerated nitrogensource for nutritional support and therapy of
patients with liver disease who have hepatic encephalopathy. The precise
mechanisms which produce the therapeutic effects of this amino acid
formulation are not known. The etiopathology of hepatic encephalopathy
is also unknown and is thought to be of multifactorial origin. The
rationale for this amino acid formulation is based on observations of
plasma amino acid imbalances in patients with liver disease and 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 the infusion of this
amino acid formulation 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 trendtoward
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 as this amino acid injection. When infused with
hypertonic dextrose as a calorie source, supplemented with electrolytes,
vitamins, and minerals, this amino acid formulation 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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8%
Hepatasol (Amino Acid) Injection 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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8%
Hepatasol (Amino Acid) Injection is supplied sterile and
nonpyrogenic in glass containers packaged as follows: Exposure of
pharmaceutical products to heat should be minimized. Avoid excessive
heat. Protect from freezing. It is recommended the product be stored at
room temperature (25��C/77��F): brief exposure up to 40��C/104��F does not
adversely affect the product. Protect from light
until use. Caution: Federal (USA) law prohibits
dispensing without prescription. 071905013 Baxter Healthcare Corporation Clintec Nutrition
Division Deerfield, IL 60015
USA Printed in USA Copyright 1997,
1999, 2000, Baxter Healthcare Corporation. All rights reserved. 07-19-05-013
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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 8% Hepatasol (Amino
Acid) Injection 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
this amino acid formulation 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. 8%
Hepatasol (Amino Acid) Injection contains less
than 3 mEq chloride per liter. 8%
Hepatasol (Amino Acid) Injection contains 10
mmoles/Liter of phosphate. 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. 8%
Hepatasol (Amino Acid) Injection 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 8%
Hepatasol (Amino Acid) Injection only if
solution is clear, the seal unbroken, and vacuum is present. Carcinogenesis, mutagenesis, impairment of fertility: Studies
with 8% Hepatasol (Amino Acid) have not been
performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.<br/>Usage in Pregnancy:<br/>Pregnancy
Category C.: Animal reproduction studies have not been conducted
with 8% Hepatasol (Amino Acid) Injection. It
is also not known whether 8% Hepatasol
(Amino Acid) Injection can cause fetal harm when
administered to a pregnant woman or can affect
reproduction capacity. 8% Hepatasol (Amino
Acid) Injection should be given to a pregnant woman only
if clearly needed.<br/>Nursing Mothers:: Caution
should be exercised when 8% Hepatasol (Amino Acid)
is administered to a nursing woman.<br/>Pediatric Use:: Safety and
effectiveness of 8% Hepatasol (Amino Acid) Injection
in pediatric patients have not been established by adequate and
well-controlled studies. However, the use of amino acid
injections in pediatric patients as an adjunct in the offsetting
of nitrogen loss or in the treatment of negative nitrogen
balance is referenced in the medical literature. See DOSAGE AND
ADMINISTRATION.<br/>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.<br/>Technical.: The
placement of a central venous catheter should be regarded as a surgical procedure. One should be fully acquainted with various techniques of catheter insertion
as well as recognition and treatment of complications.
For details of techniques and placement sites, consult
the medical literature. X-ray is the best means of
verifying catheter placement. Complications known to
occur from the placement of central venous catheters are
pneumothorax, hemothorax, hydrothorax, artery puncture
and transection, injury to the brachial plexus,
malposition of the catheter, formation of arterio-venous
fistula, phlebitis, thrombosis, pericardial tamponade,
and air and catheter embolus.<br/>Septic.: The
constant risk of sepsis is present during total
parenteral nutrition. Since contaminated solutions and
infusion catheters are potential sources of infection, it is imperative that the preparation of solutions and
the placement and care of catheters be accomplished under controlled aseptic conditions. Solutions should ideally be prepared in the hospital
pharmacy in a laminar flow hood. The key factor in their
preparation is careful aseptic technique to avoid
inadvertent touch contamination during mixing of
solutions and subsequent admixtures. Solutions should be used promptly after mixing. Any
storage should be under refrigeration for as brief a
time as possible. Administration time for a single
bottle and set should never exceed 24 hours. Consult the medical literature for a discussion of the
management of sepsis. In brief, typical management
includes replacing the solution being administered with
a fresh container and set, and culturing the contents
for bacterial or fungal contamination. If sepsis
persists and another source of infection is not identified, the catheter is removed, the proximal tip
cultured, and a new catheter reinserted when the fever
has subsided. Non-specific, prophylactic antibiotic
treatment is not recommended. Clinical experience indicates that the catheter is
likely to be the prime source of infection as opposed to
aseptically prepared and properly stored
solutions.<br/>Metabolic.: The
following metabolic complications have been reported
during the use of central venous nutrition: metabolic
acidosis, hypophosphatemia, alkalosis, hyperglycemia and
glycosuria, osmotic diuresis and dehydration, rebound
hypoglycemia, elevated liver enzymes, hypo- and
hyper-vitaminosis, electrolyte imbalances and hyperammonemia in children. Frequent clinical evaluation
and laboratory determinations are necessary, especially
during the first few days of therapy to prevent or
minimize these complications.
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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.
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Leucine, Isoleucine, Valine, Lysine, Threonine, Methionine, Phenylalanine, Tryptophan, Glycine, Proline, Alanine, Arginine, Serine, Histidine and Cysteine
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Hepatasol (Injection)
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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 this amino acid formulation. 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. 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.
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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 bisulfite, a 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 complications
which 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.
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8%
Hepatasol (Amino Acid) Injection is indicated for the
treatment of hepatic encephalopathy in patients with cirrhosis or
hepatitis. 8% Hepatasol (Amino Acid) Injection 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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Hepatasol
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