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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)

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)

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

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 or any component of the formulation; inborn errors of amino acid metabolism; hepatic coma; severe renal failure; metabolic disorders involving impaired nitrogen utilization

Dosing: Adult

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 1.3 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

Dosing: Renal Impairment

Use with caution in patients with renal insufficiency. Use is contraindicated in patients with severe renal failure.

Dosing: Hepatic Impairment

In patients with hepatic insufficiency, conservative doses should be considered; use with caution. Use is 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.

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

Adverse Reactions

Frequency not defined.

Cardiovascular: Phlebitis, thrombosis

Dermatologic: Erythema

Endocrine & metabolic: Fluid and electrolyte disturbance

Genitourinary: Azotemia

Warnings/Precautions

Disease-related concerns:

• Heart failure: Use with caution in patients sensitive to volume overload (eg, heart failure, hepatic failure); consider concentrated total parenteral nutrition formula.

• Hepatic impairment: Use caution in protein delivery especially in patients with hepatic encephalopathy; 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 severe renal impairment; dosage adjustments may be necessary depending upon renal replacement therapy options. It is essential to provide adequate calories in a minimal amount of fluid. Monitor fluid balance closely.

Dosage form specific issues:

• Aluminum: The parenteral product may contain aluminum; toxic aluminum concentrations may be seen with high doses, prolonged use, or renal dysfunction. 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.

• Sulfites: Some products contain sulfites as preservatives.

Other warning/precautions:

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

Monitoring Parameters

General patient monitoring during IV nutritional therapy

Bone densitometry: Perform upon initiation of long-term therapy.

Efficacy: Nutrition and outcome parameters should be measured serially.

Electrolytes: Sodium, potassium, chloride, bicarbonate, and fluid status should be monitored frequently upon initiation and until stable; phosphate should be monitored closely in patients with pulmonary disease.

Glucose: In patients with diabetes or patients with glucose intolerance risk factors, monitor closely. Monitor frequently upon initiation of therapy and with any changes in insulin dose or renal function.

Kidney function tests: Monitor BUN and UUN.

Line site: Monitor for signs and symptoms of infection.

Liver function tests: Monitor periodically.

Neonates: Sodium, calcium, and phosphate should be monitored closely.

Refeeding syndrome: Patients at risk should have phosphorus, magnesium, potassium, and glucose levels monitored closely at initiation.

Triglycerides: Before initiation of lipid therapy and at least weekly during therapy.

Vitamin A status: Should be carefully monitored 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 hyperemesis gravidarum, parenteral nutrition may be considered for any woman who cannot maintain her weight because of vomiting (ACOG, 2004).

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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