Drug: Aminosyn HF 8%

Aminosyn-HF 8% (amino acid injection 8%) is a sterile, nonpyrogenic, hypertonic solution for intravenous infusion. The formulation is described below: Aminosyn-HF 8% An Amino Acid Injection–Hepatic Formula Essential Amino Acids (mg/100 mL)
Isoleucine 900 Leucine 1,100 Lysine (acetate)* 610 Methionine 100 Phenylalanine 100 Threonine 450 Tryptophan 66 Valine 840 *Amount cited is for lysine alone and does not include the acetate salt. Nonessential Amino Acids (mg/100 mL)
Alanine 770 Arginine 600 Cysteine HCl • H20 < 20 Glycine 900 Histidine 240 Proline 800 Serine 500 Electrolytes (mEq/Liter)
Sodium (Na+) 11 Phosphate (HPO=4) 20a Acetate (C2H3O2-)b approx. 62c Chloride (Cl-) < 3 a 10 mmoles P/L
b Including ions for pH adjustment
c From lysine acetate Product Characteristics per 100 mL
Nitrogen 1.2gd Sodium Hydrosulfite 100mge Phosphoric Acid 115mg pH 6.4 pH Range 6.0 to 7.0f Osmolarity 768 mOsmol/Liter Specific Gravity 1.02 d 7.6g of protein equivalent
e Added as the antioxidant
f Adjusted with glacial acetic acid The formulas for the individual amino acids present in Aminosyn–HF 8% are as follows: Essential Amino Acids
Isoleucine CH3CH2CH(CH3)CH(NH2)COOH Leucine (CH3)2CHCH2CH(NH2)COOH Lysine (acetate) H2N(CH2)4CH(NH2)COOH • CH3COOH Methionine CH3S(CH2)2CH(NH2)COOH Phenylalanine CH2CH(NH2)COOH Threonine CH3CH(OH)CH(NH2)COOH Tryptophan CH2CH(NH2)COOH Valine (CH3)2CHCH(NH2)COOH Nonessential Amino Acids
Alanine CH3CH(NH2)COOH Arginine H2NC(NH)NH(CH2)3CH(NH2)COOH Cysteine HCl • H20 HSCH2CH(NH2)COOH • HCl • H20 Glycine H2NCH2COOH Histidine CH2CH(NH2)COOH Proline Serine HOCH2CH(NH2)COOH 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. Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

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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 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. 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. Read the Aminosyn HF 8% (amino acid injection hepatic formula) Side Effects Center for a complete guide to possible side effectsLearn More »

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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 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 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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No information provided. Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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 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. Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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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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. Revised August, 2005. Hospira, Inc., Lake Forest, IL 60045 USA. FDA Rev date: 4/1/1998 Last reviewed on RxList: 1/13/2009
This monograph has been modified to include the generic and brand name in many instances.

Source: http://www.rxlist.com

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. Carcinogenesis, Mutagenesis, Impairment of Fertility Studies with Aminosyn-HF 8% have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. 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. Nursing Mothers Caution should be exercised when Aminosyn–HF 8% is administered to a nursing woman. Pediatric Use Safety and effectiveness in pediatric patients have not been established. 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 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 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.

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