HepatAmine
From Standard of Care
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| Provides a well tolerated nitrogen source for nutritional support and therapy of patients with liver disease with hepatic encephalopathy. | Provides a well tolerated nitrogen source for nutritional support and therapy of patients with liver disease with hepatic encephalopathy. | ||
| + | |||
| + | Mnagement of patients with liver disease is to provide nutrition with sufficient amino acid and caloric support for protein synthesis without exacerbating hepatic encephalopathy. | ||
| Infusion reverses the abnormal plasma amino acid pattern characterized by decreased levels of branched chain amino acids and elevated levels of aromatic amino acids and methionine present in hepatic encephalopathy. | Infusion reverses the abnormal plasma amino acid pattern characterized by decreased levels of branched chain amino acids and elevated levels of aromatic amino acids and methionine present in hepatic encephalopathy. | ||
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| HepatAmine contains less than 3 mEq chloride per liter, and 10 mmole/liter of phosphate, contains no more than 25 µg/L of aluminum. | HepatAmine contains less than 3 mEq chloride per liter, and 10 mmole/liter of phosphate, contains no more than 25 µg/L of aluminum. | ||
| + | Substantially excreted by the kidney. | ||
| - | Laboratory tests should include measurement of blood sugar, electrolyte, and serum protein concentrations; kidney and liver function tests; and evaluation of acid-base balance and fluid balance. Other laboratory tests may be suggested by the patient's condition. | ||
| - | Drug Interactions | ||
| - | |||
| - | Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. | ||
| - | Carcinogenesis, Mutagenesis, Impairment of Fertility | ||
| - | |||
| - | No in vitro or in vivo carcinogenesis, mutagenesis, or fertility studies have been conducted with HepatAmine® (8% Amino Acid Injection). | ||
| - | Pregnancy | ||
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| - | Teratogenic Effects - Pregnancy Category C. | ||
| - | Pregnancy Category C. Animal reproduction studies have not been conducted with HepatAmine (8% Amino Acid Injection). It is also not known whether HepatAmine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. HepatAmine should be given to a pregnant woman only if clearly needed. | ||
| - | Labor and Delivery | ||
| - | |||
| - | Information is unknown. | ||
| - | Nursing Mothers | ||
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| - | It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when HepatAmine is administered to a nursing woman. | ||
| - | Pediatric Use | ||
| - | |||
| - | Safety and effectiveness of amino acid injections 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 well established in the medical literature. | ||
| - | See WARNINGS and DOSAGE AND ADMINISTRATION. | ||
| - | Geriatric Use | ||
| - | |||
| - | Clinical studies of HepatAmine did not include sufficient numbers of subjects age 65 years 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 of the dosing range, 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 function. | ||
| - | See WARNINGS. | ||
| - | Special Precautions for Central Venous Nutrition | ||
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| - | 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. | ||
| - | 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. | ||
| - | 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. | ||
| - | 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 pediatric patients. Frequent clinical evaluation and laboratory determinations are necessary, especially during the first few days of therapy to prevent or minimize these complications. | ||
| - | Adverse Reactions | ||
| - | 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 HepatAmine® (8% Amino Acid Injection). | ||
| - | 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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| - | Overdosage | ||
| - | In the event of a fluid or solute overload during parenteral therapy, reevaluate the patient's condition, and institute appropriate corrective treatment. | ||
| - | HepatAmine Dosage and Administration | ||
| - | 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 HepatAmine 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 total daily dose of HepatAmine 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 HepatAmine® (8% Amino Acid Injection) per day. Typically, 500 mL of 8% HepatAmine 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. | The recommended dosage is 80–120 grams of amino acids (12–18 grams of nitrogen) as HepatAmine® (8% Amino Acid Injection) per day. Typically, 500 mL of 8% HepatAmine 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. | ||
Revision as of 00:50, 7 May 2012
An 8% Amino Acid Injection which is a sterile, nonpyrogenic, hypertonic solution containing crystalline amino acids.
A 500 mL unit provides a total of 40 g of amino acids and 6 g of nitrogen (38 g of protein equivalent).
Each 100 mL contains:
Essential Amino Acids
Isoleucine USP..............................................0.90 g
Leucine USP.................................................1.10 g
Lysine...........................................................0.61 g (added as Lysine Acetate USP.....0.86 g)
Methionine USP............................................0.10 g
Phenylalanine USP.........................................0.10 g
Threonine USP..............................................0.45 g
Tryptophan USP.........................................0.066 g
Valine USP...................................................0.84 g
Nonessential Amino Acids
Alanine USP..................................................0.77 g
Arginine USP.................................................0.60 g
Histidine USP.................................................0.24 g
Proline USP...................................................0.80 g
Serine USP....................................................0.50 g
Glycine USP..................................................0.90 g
Cysteine....................................................<0.014 g (as Cysteine HCl•H2O USP.................<0.020 g)
Phosphoric Acid NF....................................0.115 g
Sodium Bisulfite (as an antioxidant)................<0.1 g
Water for Injection USP......................................qs
pH adjusted with Glacial Acetic Acid USP
pH: 6.5 (6.0–6.8)
Calculated Osmolarity: 785 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 10; Chloride <3
Phosphate (HPO) 20 (10 mmole P/liter); Acetate Approx. 62 (provided as acetic acid and Iysine acetate)
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, compared to general purpose amino acid infusions.
Provides a well tolerated nitrogen source for nutritional support and therapy of patients with liver disease with hepatic encephalopathy.
Mnagement of patients with liver disease is to provide nutrition with sufficient amino acid and caloric support for protein synthesis without exacerbating hepatic encephalopathy.
Infusion reverses the abnormal plasma amino acid pattern characterized by decreased levels of branched chain amino acids and elevated levels of aromatic amino acids and methionine present in hepatic encephalopathy.
Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration.
When utilized with hypertonic dextrose, electrolytes, vitamins, and minerals provides total parenteral nutrition in patients with liver disease, with the exception of essential fatty acids.
Indicated for the treatment of hepatic encephalopathy in patients with cirrhosis or hepatitis.
Use 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 amino acids present in the solution.
Contains sodium bisulfite, that may cause allergic-type reactions in susceptible individuals.
Contains aluminum that may reach toxic levels with prolonged parenteral administration if kidney function is impaired, and premature neonates are particularly at risk because their kidneys are immature.
HepatAmine contains less than 3 mEq chloride per liter, and 10 mmole/liter of phosphate, contains no more than 25 µg/L of aluminum.
Substantially excreted by the kidney.
The total daily dose of HepatAmine 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 HepatAmine® (8% Amino Acid Injection) per day. Typically, 500 mL of 8% HepatAmine 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. 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. 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 mmole 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 HepatAmine must be considered when calculating daily electrolyte intake. Serum electrolytes, including magnesium and phosphorus, should be monitored frequently. Pediatric Use
Use of HepatAmine 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 mOsmol/L). 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% HepatAmine may be administered by peripheral vein with or without parenteral carbohydrate calories. Such infusates can be prepared by dilution of 8% HepatAmine 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).
