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Amino Acid Injection

Pronunciation

(a MEE noe AS id in JEK shun)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Intravenous:

Aminosyn: 3.5% (1000 mL [DSC]); 7% (500 mL [DSC]); 8.5% (500 mL, 1000 mL [DSC]); 10% (500 mL, 1000 mL) [latex free, sulfite free]

Aminosyn II: 10% (2000 mL [DSC])

Aminosyn II: 15% (2000 mL [DSC]) [latex free; contains sodium hydrosulfite]

Aminosyn II: 7% (500 mL); 8.5% (500 mL, 1000 mL); 10% (2000 mL) [latex free, sulfite free]

Aminosyn II: 10% (500 mL, 1000 mL); 15% (2000 mL) [sulfite free]

Aminosyn II/Electrolytes: 8.5% (500 mL) [latex free, sulfite free]

Aminosyn M: 3.5% (1000 mL) [latex free, sulfite free]

Aminosyn-HBC: 7% (500 mL) [latex free, sulfite free]

Aminosyn-HF: 8% (500 mL [DSC]) [latex free]

Aminosyn-PF: 7% (500 mL); 10% (1000 mL) [latex free, sulfite free]

Aminosyn-RF: 5.2% (500 mL) [latex free, sulfite free]

Aminosyn/Electrolytes: 8.5% (500 mL, 1000 mL) [latex free, sulfite free]

Clinimix E/Dextrose (2.75/10): 2.75% (1000 mL, 2000 mL) [sulfite free]

Clinimix E/Dextrose (2.75/5): 2.75% (1000 mL, 2000 mL) [sulfite free]

Clinimix E/Dextrose (4.25/10): 4.25% (1000 mL, 2000 mL) [sulfite free]

Clinimix E/Dextrose (4.25/25): 4.25% (1000 mL, 2000 mL) [sulfite free]

Clinimix E/Dextrose (4.25/5): 4.25% (1000 mL, 2000 mL) [sulfite free]

Clinimix E/Dextrose (5/15): 5% (1000 mL, 2000 mL) [sulfite free]

Clinimix E/Dextrose (5/20): 5% (1000 mL, 2000 mL) [sulfite free]

Clinimix E/Dextrose (5/25): 5% (1000 mL, 2000 mL) [sulfite free]

Clinimix/Dextrose (2.75/5): 2.75% (1000 mL) [sulfite free]

Clinimix/Dextrose (4.25/10): 4.25% (1000 mL, 2000 mL) [sulfite free]

Clinimix/Dextrose (4.25/20): 4.25% (1000 mL, 2000 mL) [sulfite free]

Clinimix/Dextrose (4.25/25): 4.25% (1000 mL, 2000 mL) [sulfite free]

Clinimix/Dextrose (4.25/5): 4.25% (1000 mL, 2000 mL) [sulfite free]

Clinimix/Dextrose (5/15): 5% (1000 mL, 2000 mL) [sulfite free]

Clinimix/Dextrose (5/20): 5% (1000 mL, 2000 mL) [sulfite free]

Clinimix/Dextrose (5/25): 5% (1000 mL, 2000 mL) [sulfite free]

Clinisol SF: 15% (500 mL, 2000 mL) [sulfite free]

FreAmine HBC: 6.9% (750 mL)

FreAmine III: 3% (1000 mL [DSC])

FreAmine III: 8.5% (1000 mL [DSC]); 10% (1000 mL) [contains sodium bisulfite]

Hepatamine: 8% (500 mL)

Hepatasol: 8% (500 mL [DSC]) [sulfite free]

NephrAmine: 5.4% (250 mL)

Plenamine: 15% (1000 mL) [contains sodium metabisulfite]

Premasol: 6% (500 mL); 10% (500 mL, 1000 mL, 2000 mL) [sulfite free]

Prosol: 20% (2000 mL)

Travasol: 10% (500 mL, 1000 mL, 2000 mL) [sulfite free]

Trophamine: 6% (500 mL)

TrophAmine: 10% (500 mL)

Brand Names: U.S.

  • Aminosyn
  • Aminosyn II
  • Aminosyn II/Electrolytes
  • Aminosyn M
  • Aminosyn-HBC
  • Aminosyn-HF [DSC]
  • Aminosyn-PF
  • Aminosyn-RF
  • Aminosyn/Electrolytes
  • Clinimix E/Dextrose (2.75/10)
  • Clinimix E/Dextrose (2.75/5)
  • Clinimix E/Dextrose (4.25/10)
  • Clinimix E/Dextrose (4.25/25)
  • Clinimix E/Dextrose (4.25/5)
  • Clinimix E/Dextrose (5/15)
  • Clinimix E/Dextrose (5/20)
  • Clinimix E/Dextrose (5/25)
  • Clinimix/Dextrose (2.75/5)
  • Clinimix/Dextrose (4.25/10)
  • Clinimix/Dextrose (4.25/20)
  • Clinimix/Dextrose (4.25/25)
  • Clinimix/Dextrose (4.25/5)
  • Clinimix/Dextrose (5/15)
  • Clinimix/Dextrose (5/20)
  • Clinimix/Dextrose (5/25)
  • Clinisol SF
  • FreAmine HBC
  • FreAmine III
  • Hepatamine
  • Hepatasol [DSC]
  • NephrAmine
  • Plenamine
  • Premasol
  • Prosol
  • Travasol
  • TrophAmine
  • Trophamine

Pharmacologic Category

  • Intravenous Nutritional Therapy

Pharmacology

Promote protein synthesis and wound healing, and reduce the rate of endogenous protein catabolism.

Use: Labeled Indications

Component of parenteral nutrition: As part of parenteral nutrition to prevent nitrogen loss or treat negative nitrogen balance when alimentary tract cannot be used (eg, GI absorption is impaired, bowel rest is needed). Specialty amino acid formulas may be considered only in certain instances.

Contraindications

Hypersensitivity to one or more amino acids, dextrose, or any component of the formulation; inborn errors of amino acid metabolism; hepatic coma, severe renal failure, metabolic disorders involving impaired nitrogen utilization (excluding Clinimix and Clinimix E); pulmonary edema or acidosis due to low cardiac output (Clinimix and Clinimix E); neonates (<28 days of age) receiving concomitant ceftriaxone (Clinimix E).

Dosing: Adult

Note: Correct severe fluid, electrolyte, and acid-base disorders prior to administration.

Component of parenteral nutrition: Protein as amino acids: IV:

Maintenance: 0.8 to 1 g/kg/day

Normal/mild stress level: 1 to 1.2 g/kg/day

Moderate stress level: 1.2 to 1.5 g/kg/day

Severe stress level: 1.5 to 2 g/kg/day

Burn patients (severe): Increase protein until significant wound healing achieved

Solid organ transplant: Perioperative: 1.5 to 2 g/kg/day

Renal failure:

Acute (severely malnourished or hypercatabolic): 1.5 to 1.8 g/kg/day

Chronic, with dialysis: 1.2 to 1.8 g/kg/day (maximum: 2.5 g/kg/day)

Chronic, without dialysis: 0.6 to 0.8 g/kg/day

Continuous hemofiltration: ≥1 g/kg/day

Hepatic failure:

Acute management when other treatments have failed:

With encephalopathy: 0.6 to 1 g/kg/day

Without encephalopathy: 1 to 1.5 g/kg/day

Chronic encephalopathy: Use branch chain amino acid enriched diets only if unresponsive to pharmacotherapy

Pregnant women in second or third trimester: Add an additional 10 to 14 g/day

Dosing: Pediatric

Component of parenteral nutrition: Protein as amino acids: IV:

Infants, Children, and Adolescents:

Term: Initial: 2.5 g/kg/day; Goal: 3 g/kg/day

Extremely (<1,000 g) and very (<1,500 g) low-birth-weight (stable): Initial: 1 to 1.5 g/kg/day; Goal: 3.5 to 3.85 g/kg/day to promote utero growth rates

Sepsis, hypoxia: Initial: 1 g/kg/day; goal: 3 to 3.85 g/kg/day

Clinimix, Clinimix E:

Infants <1 month: 3 to 4 g /kg/day

Infants 1 month to <1 year: 2 to 3 g/kg/day

Children 1 to <11 years: 1 to 2 g/kg/day

Children ≥11 years and Adolescents ≤17 years: 0.8 to 1.5 g/kg/day

Dosing: Renal Impairment

Use with caution in patients with renal impairment; dosage adjustment may be necessary. Some products are contraindicated in patients with severe renal failure.

Dosing: Hepatic Impairment

Use with caution in patients with hepatic impairment; dosage adjustments may be necessary. Some products are contraindicated in patients in hepatic coma.

Administration

IV: Administered as a component of peripheral parenteral or total parenteral nutrition. Peripheral administration of nutrition is dependent upon osmolality of solution. Total parenteral nutrition must be administered via central venous access. May require use of inline filter (consult specific product labeling and/or individual institutional policies and procedures). Initiation and termination of nutritional fluids must be gradual to permit endogenous insulin release adjustment. Consult specific product labeling for maximum infusion rates.

Vesicant; ensure proper needle or catheter placement prior to and during IV infusion. Avoid extravasation.

Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave needle/cannula in place); gently aspirate extravasated solution (do NOT flush the line); initiate hyaluronidase antidote; remove needle/cannula; apply dry cold compresses (Hurst 2004); elevate extremity.

Hyaluronidase: Intradermal or SubQ: Inject a total of 1 mL (15 units/mL) as five separate 0.2 mL injections (using a 25-gauge needle) into area of extravasation at the leading edge in a clockwise manner (MacCara 1983; Zenk 1981).

Storage

Store at 20°C to 25°C (68°F to 77°F); avoid excessive heat; do not freeze. Protect from light.

Clinimix and Clinimix E: May store briefly up to 40°C (104°F). Once the protective foil overwrap has been opened, may store in refrigerator ≤9 days. Once mixed, use promptly or may store refrigerated for <24 hours. After removal from refrigerator, use promptly and complete the infusion ≤24 hours. Discard any remaining mixture.

Adverse Reactions

Frequency not defined.

Cardiovascular: Phlebitis, thrombosis

Dermatologic: Erythema

Endocrine & metabolic: Fluid and electrolyte disturbance

Genitourinary: Azotemia

Warnings/Precautions

Concerns related to adverse effects:

• Hepatic effects: Parenteral nutrition associated liver disease has been reported in patients receiving parenteral nutrition for extended periods of time, especially preterm infants, and can present as cholestasis or steatohepatitis; cholecystitis, cholelithiasis, cholestasis, hepatic steatosis, fibrosis and cirrhosis, and hepatic failure have also been reported. Increase in blood ammonia levels and hyperammonemia may also occur. Consider discontinuation or dose reduction in patients who develop abnormal LFTs.

• Hyperglycemia or hyperosmolar hyperglycemic state: Administration of dextrose at a rate exceeding the patient’s utilization rate may lead to hyperglycemia, coma, and death. Patients with underlying confusion and renal impairment who receive dextrose infusions may be at greater risk of developing hyperosmolar hyperglycemic state. Monitor blood glucose levels.

• Hypersensitivity/infusion reactions: Hypersensitivity/infusion reactions including anaphylaxis have been reported. Stop infusion immediately and treat patient accordingly if any signs or symptoms of a hypersensitivity reaction develop.

• Refeeding syndrome: Refeeding severely undernourished patients may result in refeeding syndrome (eg, intracellular shift of potassium, phosphorus, and magnesium as the patient becomes anabolic); thiamine deficiency and fluid retention may also develop. Carefully monitor severely undernourished patients and slowly increase nutrient intakes, while avoiding overfeeding.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with cardiovascular disease (eg, cardiac insufficiency due to left ventricular systolic dysfunction, heart failure); these patients are susceptible to excessive fluid accumulation; dosage adjustments may be necessary. Consider concentrated total parenteral nutrition formula.

• Diabetes: Use with caution in patients with diabetes mellitus. Monitor blood glucose levels and treat hyperglycemia to maintain optimum levels.

• Hepatic impairment: Use with caution in patients with hepatic impairment; dosage adjustments may be necessary. Consider volume status in patients with hepatic failure, may require concentrated total parenteral nutrition formula.

• Renal impairment: Use with caution in patients with renal impairment; may be at risk of electrolyte and fluid volume imbalance; dosage adjustments may be necessary. May contain aluminum, which may accumulate following prolonged administration in patients with renal impairment.

Concurrent drug therapy issues:

• Ceftriaxone: Precipitation of ceftriaxone-calcium may occur when ceftriaxone is mixed with calcium-containing parenteral nutrition solutions in the same IV line. Do not administer ceftriaxone simultaneously via a Y-site with calcium-containing parenteral solutions. Concurrent use is contraindicated in neonates <28 days receiving ceftriaxone. In patients ≥28 days, may administer sequentially if the infusion lines are thoroughly flushed between infusions with a compatible fluid.

Dosage form specific issues:

• Aluminum: The parenteral product may contain aluminum; toxic aluminum concentrations may be seen with high doses, prolonged use, or renal impairment. Premature neonates are at higher risk due to immature renal function and aluminum intake from other parenteral sources. Parenteral aluminum exposure of >4 to 5 mcg/kg/day is associated with CNS and bone toxicity; tissue loading may occur at lower doses (Federal Register 2002). See manufacturer's labeling.

• Precipitates: Periodically inspect solution, infusion set and catheter for precipitates. Pulmonary vascular precipitates causing pulmonary vascular emboli and pulmonary distress has been reported (some fatal). If signs of pulmonary distress occur, stop the infusion.

• Sulfites: Some products may contain sulfites as preservatives.

Other warning/precautions:

• Administration: For central or peripheral IV administration; peripheral administration of nutrition is dependent upon osmolality of solution.

• Extravasation: Vesicant; ensure proper catheter or needle position prior to and during infusion. Avoid extravasation.

Monitoring Parameters

Fluid and electrolyte status, serum osmolarity, blood glucose, renal and hepatic function, ammonia levels, blood count and coagulation parameters throughout treatment; serum lipids in patients maintained on fat-free parenteral nutrition; signs and symptoms of infection and frequent checks of the parenteral access device and insertion site for edema, redness and discharge; bone densitometry (upon initiation of long-term therapy); vitamin A status (in patients with chronic renal failure).

Pregnancy Risk Factor

C

Pregnancy Considerations

Animal reproduction studies have not been conducted. Following administration, an increase of some amino acids is observed in the fetus (Ronzoni 1999; Ronzoni 2002). In women with nausea and vomiting of pregnancy, parenteral nutrition should be used as a last option for any woman who cannot maintain her weight because of vomiting; enteral nutrition is preferred (ACOG 2015).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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