This site is intended for U.S. healthcare professionals only
Amino Acid Injections

Amino acid injections are indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.

Amino Acid Injections

A broad range of sulfite-free Amino Acid Injections from 6% to 10% Pediatric and 10%, 15% and 20% Adult Solution concentrations in flexible containers. The only 20% concentration option available.

20% PROSOL sulfite-free (Amino Acid) Injection

Indications

20% PROSOL Injection is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns. 20% PROSOL Injection can be used to reduce fluid intake in patients who require both fluid restriction and total parenteral nutrition (TPN). 20% PROSOL Injection is intended to be dosed on the basis of grams of amino acids/kg body weight/day. Therefore, this more concentrated amino acid provides the same nutritional value as in a more dilute form, but with the opportunity to limit fluid intake.

Central Vein Administration: 20% PROSOL sulfite-free (Amino Acid) Injection is intended for use in a pharmacy admixture program and as such is restricted to the preparation of admixtures for intravenous use. Central vein infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis such as for hypercatabolic or depleted patients or those requiring long term parenteral nutrition. 20% PROSOL sulfite-free (Amino Acid) Injection should never be administered undiluted.

Peripheral Vein Administration: For patients in whom the central vein route is not indicated, amino acid solutions diluted with low dextrose concentrations may be infused by peripheral vein with or without supplemented fat emulsion. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L). 20% PROSOL sulfite-free (Amino Acid) Injection should never be administered undiluted.

Protein Sparing: Dilute amino acid solutions for peripheral administration may be used in patients who exhibit no clinically significant protein malnutrition. The purpose of the solution is to replace protein losses which occur in relation to an intercurrent phenomenon which is known or suspected to be productive of a protein loss condition for a short or moderate period of time. Protein-sparing can be achieved by peripheral infusion of dilute amino acid solutions with or without dextrose. 20% PROSOL sulfite-free (Amino Acid) Injection must be diluted below twice normal serum osmolarity (718 mOsmol/L).

Important Risk Information

  • Contraindicated in patients with hypersensitivity to one or more amino acids, severe liver disease or hepatic coma and anuria.
  • This injection is for compounding only, not for direct infusion and as such, should never be administered undiluted.
  • Because of the potential for life threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture. Use of a final filter is recommended during administration of all parenteral solutions where possible. Caution should be exercised when admixing 20% PROSOL Injection and should be used promptly after admixing.
  • Proper administration of this injection requires knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.
  • Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor and coma. Hyperammonemia is of special significance in infants. This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants.
  • Conservative doses should be given to patients with known or suspected hepatic dysfunction. Should symptoms of hyperammonemia develop, administration should be discontinued and the patient's clinical status reevaluated.
  • Administration of amino acid solutions in the presence of impaired renal function presents special issues associated with retention of electrolytes.
  • This injection should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination.
  • This product contains aluminum that may be toxic with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amount 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 μg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
  • Administration by central venous catheter should be used only by those familiar with this technique and its complications.
  • The administration of 20% PROSOL Injection in combination with highly concentrated dextrose solutions, hyperglycemia, glycosuria and hyperosmolar syndrome may result. Blood and urine glucose should be monitored on a routine basis in patients receiving this therapy. Sudden cessation in administration of a concentrated dextrose solution may result in insulin reaction due to high levels of endogenous insulin. Parenteral nutrition mixtures should be withdrawn slowly.
  • Because of its antianabolic activity, concurrent administration of tetracycline may reduce the protein-sparing effect of infused amino acids.
  • Care should be taken to avoid excess fluid accumulation, particularly in patients with renal disease, pulmonary insufficiency and heart disease.
  • During protein-sparing therapy in the absence of supporting carbohydrate metabolism, an accumulation of ketone bodies in the blood often occurs. Correction of ketonemia usually can be accomplished by administering some carbohydrates. Protein-sparing therapy is useful for periods up to 10 to 12 days. Patients requiring nutritional support thereafter should be placed on oral or parenteral regimens that employ adequate non-protein calorie components.
  • Frequent clinical evaluations and laboratory determinations are necessary for proper monitoring during administration. Laboratory tests should include blood glucose, serum electrolytes, liver and kidney function, serum osmolarity, blood ammonia, serum protein, pH, hematocrit, WBC, and urinary glucose. When infusing without adequate non-protein calories, monitoring of BUN is required.
  • The following metabolic complications have been reported: metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia and glycosuria, osmotic diuresis and dehydration, rebound hypoglycemia, elevated liver enzymes, hypo and hypervitaminosis, electrolyte imbalances and hyperammonemia. Frequent clinical evaluation and laboratory determinations are necessary, especially during the first few days of therapy, to prevent or minimize these complications.
  • Infusion of any hypertonic solution can result in local inflammatory reactions. Policies and procedures should be established for the recognition and management of such reactions.

Please see full prescribing information

15% CLINISOL sulfite-free (Amino Acid) Injection

Indications

15% CLINISOL sulfite-free (Amino Acid) Injection is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.

Important Risk Information

  • Contraindicated in patients with hypersensitivity to one or more amino acids, severe liver disease or hepatic coma, Anuria and Metabolic disorders involving impaired nitrogen utilization.
  • Because of the potential for life threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrition admixture.
  • This injection is for compounding only, not for direct infusion.
  • Administration of amino acid solutions at excessive rates or to patients with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma. If hyperammonemia develops, discontinue the amino acid administration and reevaluate the patient's clinical status.
  • This product contains aluminum that may be toxic with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amount of calcium and phosphate solutions, which contain aluminum.
  • The administration of 15% Clinisol Injection as part of the total parenteral nutrition with large volumes of hyperosmotic fluids requires periodic monitoring for signs of hyperosmolarity, hyperglycemia, glycosuria, hypertriglyceridemia and volume overload. Initiation and termination of TPN infusion must be gradual to permit adjustment of endogenous insulin release.
  • During parenteral nutrition with concentrated dextrose and amino acid solutions, essential fatty acid deficiency syndrome may develop and therefore plasma lipids should be monitored. This syndrome may be prevented or corrected by treatment with intravenous fat emulsions.
  • Frequent clinical evaluations and laboratory determinations are necessary for proper monitoring during administration.
  • Total parenteral nutrition therapy may include multiple vitamins, trace elements and additional electrolytes. Potentially incompatible ions such as calcium and phosphate may be added to alternate infusate containers to avoid precipitation.
  • Local adverse reactions consisting of a warm sensation, erythema, phlebitis and thrombosis at the infusion site have occurred with peripheral intravenous infusion of amino acids. Generalized flushing, fever and nausea have been reported during peripheral infusions of amino acid solutions.
  • The following metabolic complications have been reported with administration of TPN: metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia, osteoporosis, glycosuria, hyperglycemia, hyperosmolar nonketotic states and dehydration, rebound hypoglycemia, osmotic diuresis and dehydration, elevated liver enzymes, hypo- and hypervitaminosis, electrolyte imbalances, hyperammonemia, coma and death.

Please see full prescribing information

10% TRAVASOL (Amino Acid) Injection

Indications

An adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.

Important Risk Information

  • Contraindicated in patients with: Hypersensitivity to one or more amino acids; Severe liver disease or hepatic coma; Anuria
  • This injection is for compounding only, not for direct infusion. Caution should be exercised when admixing 10% TRAVASOL and it should be used promptly after admixing. These solutions should be stored under refrigeration less than 24 hours.
  • Prompt administration of this injection requires knowledge of fluid and electrolyte balance and nutrition, as well as clinical expertise in recognition and treatment of the complications which may occur.
  • Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor and coma.
  • Hyperammonemia is of special significance in infants. This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants.
  • Conservative doses of this injection should be given to patients with known or suspected hepatic dysfunction. Should symptoms of hyperammonemia develop, administration should be discontinued and the patient's clinical status reevaluated.
  • Administration of amino acid solutions in patients with impaired renal function may result in retention of electrolytes.
  • This injection should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination.
  • This product contains aluminum that may be toxic with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amount of calcium and phosphate solutions, which contain aluminum.
  • Administration by central venous catheter should be used only by those familiar with this technique and its complications.
  • It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and used for protein synthesis. Concentrated dextrose solutions are an effective source of such calories. With the administration of 10% TRAVASOL (Amino Acid) Injection in combination with highly concentrated dextrose solutions, hyperglycemia, glycosuria and hyperosmolar syndrome may result. Blood and urine glucose should be monitored on a routine basis.
  • Sudden cessation in administration of a concentrated dextrose solution may result in insulin reaction due to continued endogenous insulin production. Parenteral nutrition mixtures should be withdrawn slowly.
  • Strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.
  • Because of the antianabolic activity, concurrent administration of tetracycline may reduce the protein-sparing effects of infused amino acids.
  • Care should be taken to avoid excess fluid accumulation, particularly in patients with renal disease, pulmonary insufficiency and heart disease.
  • During protein sparing therapy in the absence of supporting carbohydrate metabolism, an accumulation of ketone bodies in the blood often occurs. Correction of ketonemia usually can be accomplished by administering some carbohydrates.

Please see full prescribing information

6% and 10% PREMASOL sulfite-free (Amino Acid) Injections

Indications

6% and 10% PREMASOL sulfite-free (Amino Acid) Injections are indicated for the nutrition support of Infants (including those of very low birth weight) and young children requiring TPN via central or peripheral infusion routes. Parenteral nutrition with PREMASOL injections is indicated to prevent nitrogen and weight loss or treat negative nitrogen balance in infants and young children where: (1) the alimentary tract, by the oral, gastrostomy, or jejunostomy route, cannot or should not be used or adequate protein intake is not feasible by these routes, (2) gastrointestinal absorption of protein is impaired, or (3) protein requirements are substantially increased, as with extensive burns. Dosage, route of administration, and concomitant infusion of non-protein calories are dependent on various factors, such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutrition support, and vein tolerance.

Important Risk Information

  • PREMASOL Injections are contraindicated in patients with untreated anuria, hepatic coma, inborn errors of amino acid metabolism, including those involving branched chain amino acid metabolism such as maple syrup urine disease and isovaleric acidemia, or hypersensitivity to one or more amino acids in the solution.
  • This injection is for compounding only, not for direct infusion
  • Safe, effective use of parenteral nutrition requires knowledge of nutrition as well as clinical expertise in recognition and treatment of the complications which can occur.
  • Frequent evaluation and laboratory determinations are necessary for proper monitoring of parenteral nutrition. Depending on the patient's conditions or disease state, additional electrolyte supplementation may be required.
  • Fluid and/or solute overload resulting in dilution of serum electrolyte concentrations, overhydration, congested states, or pulmonary edema can occur with IV administration.
  • Administration of amino acids in patients with impaired renal function or gastrointestinal bleeding may augment an already elevated blood urea nitrogen. Do not infuse amino acids in patients with azotemia.
  • Administration of amino acid solutions to a patient with hepatic insufficiency may result in plasma amino acid imbalances, hyperammonemia, prerenal azotemia, stupor and coma.
  • It is essential that blood ammonia be measured frequently in infants. Hyperammonemia in the syndrome is caused by genetic metabolic defects and is sometimes associated, although not necessarily in a causal relationship, with mental retardation. This reaction appears to be dose related and is more likely to develop during prolonged therapy.
  • This product contains aluminum that may be toxic 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.
  • Strongly hypertonic nutrient solutions should be administered via an intravenous catheter placed in a central vein, preferably the superior vena cava.
  • Special care must be taken when giving hypertonic dextrose to patients with diabetes or impaired glucose tolerance. To prevent hyperglycemia in such patients, insulin may be required.
  • The final infusate should be inspected for cloudiness or precipitation immediately after mixing, prior to administration, and periodically during administration.
  • Adverse reactions reported in clinical studies were: water weight gain, edema, increase in BUN, and mild acidosis. 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 hypovolemia. Phosphorus deficiency may lead to impaired tissue oxygenation and acute hemolytic anemia. Relative to calcium, excessive phosphorous 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 counter measures and save the remainder of the fluid for examination, if deemed necessary.

Please see full prescribing information

USMP/78/14-0015