Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1073
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Hepatasol (Injection)
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dailymed-instance:dosage |
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 - sulfite-free (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 - sulfite-free (Amino Acid)
Injection per day. Typically, 500 mL of 8% HEPATASOL - sulfite-free (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 - sulfite-free (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 needs and 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 60-180 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 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 8% HEPATASOL - sulfite-free (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 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, 8% HEPATASOL -
sulfite-free (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 - sulfite-free (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. Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate
(DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers.
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dailymed-instance:descripti... |
8% HEPATASOL - sulfite-free (Amino Acid) Injection is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino
acids. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride (PL
146 Plastic). 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. The amount of water that can permeate from inside the container into the
overwrap is insufficient 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 phthalate, DEHP, at not more than 0.2 part 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. Intravenous fat emulsion should not be administered in polyvinyl chloride (PVC) containers that use di-2-ethylhexyl phthalate
(DEHP) as a plasticizer, because the fat emulsion facilitates the leaching of DEHP from these containers.
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dailymed-instance:clinicalP... |
8% HEPATASOL - sulfite-free (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 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 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 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 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 amount of chloride present is not of clinical significance.
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8% HEPATASOL - sulfite-free (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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dailymed-instance:supply |
8% HEPATASOL - sulfite-free (Amino Acid) Injection is supplied sterile and nonpyrogenic in single dose VIAFLEX plastic 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. Do not remove container from overpouch until ready to use. Do not use if overpouch has been previously opened or damaged. 071939789 Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA Printed in USA BAXTER, HEPATASOL, VIAFLEX, and PL 146 are trademarks of Baxter International Inc. 07-19-39-789
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dailymed-instance:precautio... |
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 - sulfite-free (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 - sulfite-free (Amino Acid) Injection contains less than 3 mEq chloride per liter. 8% HEPATASOL - sulfite-free (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 - sulfite-free (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 - sulfite-free (Amino Acid) Injection only if solution is clear, and the seal is intact. Drug product contains no more than 25��g/L of aluminum.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility: Studies with 8% HEPATASOL - sulfite-free (Amino Acid) have not been performed to evaluate carcinogenic potential, mutagenic
potential, or effects on fertility.<br/>Pregnancy:<br/>Teratogenic Effects:<br/>Nursing Mothers:: Caution should be exercised when 8% HEPATASOL - sulfite-free (Amino Acid) Injection is administered to a nursing
woman.<br/>Pediatric Use:: Safety and effectiveness of 8% HEPATASOL - sulfite-free (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 container 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. It 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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dailymed-instance:genericMe... |
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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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 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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dailymed-instance:warning |
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. 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. 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��g/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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8% HEPATASOL - sulfite-free (Amino Acid) Injection is indicated for the treatment of hepatic encephalopathy in patients with cirrhosis or hepatitis. 8% HEPATASOL - sulfite-free (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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