MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
TrophAmine® may be confused with tromethamine
U.S. BRAND NAMES — Aminosyn®; Aminosyn® II; Aminosyn®-HBC; Aminosyn®-PF; Aminosyn®-RF; BranchAmin®; Clinisol®; FreAmine®; FreAmine® HBC®; FreAmine® III; HepatAmine®; Hepatasol®; NephrAmine®; PremaSol™ ; Prosol; Renamin®; Travasol®; TrophAmine®
PHARMACOLOGIC CATEGORY
Intravenous Nutritional Therapy
DOSING: ADULTS — Protein as amino acids: I.V. (as a component of parenteral nutrition):
Maintenance: 0.8-1 g/kg/day
Normal/mild stress level: 1-1.2 g/kg/day
Moderate stress level: 1.2-1.5 g/kg/day
Severe stress level: 1.5-2 g/kg/day
Burn patients (severe): Increase protein until significant wound healing achieved
Solid organ transplant: Perioperative: 1.5-2 g/kg/day
Renal failure:
Acute (severely malnourished or hypercatabolic): 1.5-1.8 g/kg/day
Chronic, with dialysis: 1.2-1.3 g/kg/day
Chronic, without dialysis: 0.6-0.8 g/kg/day
Continuous hemofiltration: ≥ 1 g/kg/day
Hepatic failure:
Acute management when other treatments have failed:
With encephalopathy: 0.6-1 g/kg/day
Without encephalopathy: 1-1.5 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 10-14 g/day
DOSING: PEDIATRIC — Protein as amino acids: I.V. (as a component of parenteral nutrition):
Term: Initial: 2.5 g/kg/day; Goal: 3 g/kg/day
Extremely (<1000 g) and very (<1500 g) low-birth-weight (stable): Initial: 1-1.5 g/kg/day; Goal: 3.5-3.85 g/kg/day to promote utero growth rates
Sepsis, hypoxia: Initial: 1 g/kg/day; goal: 3-3.85 g/kg/day
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Peripheral parenteral nutrition and total parenteral nutrition are usually compounded from optimal combinations of macronutrients (water, protein, dextrose, and lipids) and micronutrients (electrolytes, trace elements, and vitamins) to meet the specific nutritional requirements of a patient. Individual hospitals may have designated standard TPN formulas. There are a few commercially-available amino acids with electrolytes solutions; however, these products may not meet an individual's specific nutritional requirements. Consult with nutrition support service to determine adequate formula based upon patient specifics.
Injection, solution [branched chain]:
Aminosyn®-HBC: 7% (500 mL, 1000 mL) [contains aluminum]
BranchAmin®: 4% (500 mL) [contains alumnium]
FreAmine® HBC: 6.9% (750 mL) [contains aluminum, sodium bisulfate]
Injection, solution [crystalline]:
Aminosyn®: 3.5% (1000 mL) [contains aluminum]; 5% (500 mL, 1000 mL) [contains aluminum]; 7% (500 mL, 1000 mL) [contains aluminum]; 8.5% (500 mL, 1000 mL) [contains aluminum]; 10% (500 mL, 1000 mL) [contains aluminum]
Aminosyn® ll: 7% (500 mL) [contains aluminum]; 8.5% (500 mL, 1000 mL) [contains aluminum]; 10% (500 mL, 1000 mL) [contains aluminum]
Aminosyn® ll: 10% (2000 mL) [contains aluminum, sodium hydrosulfite]; 15% (2000 mL) [contains aluminum, sodium hydrosulfite]
Clinisol®: 15% (500 mL, 2000 mL) [contains aluminum]
FreAmine® III: 8.5% (500 mL) [contains aluminum]; 10% (500 mL, 1000 mL) [contains aluminum]
PremaSol™ : 6% (500 mL); 10% (500 mL, 1000 mL, 2000 mL)
Prosol: 20% (2000 mL) [contains aluminum]
Travasol®: 10% (500 mL, 1000 mL, 2000 mL)
Injection, solution [hepatic]:
Aminosyn®-HF: 8% (500 mL) [contains aluminum, sodium hydrosulfite]
HepatAmine®: 8% (500 mL) [contains aluminum, sodium hydrosulfite]
Hepatasol®: 8% (500 mL) [contains aluminum]
Injection, solution [pediatric]:
Aminosyn®-PF: 7% (500 mL) [contains aluminum]; 10% (1000 mL) [contains aluminum]
TrophAmine®: 6% (500 mL); 10% (500 mL) [contains aluminum, sodium metabisulfate]
Injection, solution [renal]:
Aminosyn®-RF: 5.2% (500 mL) [contains aluminum]
NephrAmine®: 5.4% (250 mL) [contains aluminum, sodium hydrosulfite]
Renamin®: 6.5% (500 mL) [contains aluminum, sodium hydrosulfite]
DOSAGE FORMS: CONCISE — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. Peripheral parenteral nutrition and total parenteral nutrition are usually compounded from optimal combinations of macronutrients (water, protein, dextrose, and lipids) and micronutrients (electrolytes, trace elements, and vitamins) to meet the specific nutritional requirements of a patient. Individual hospitals may have designated standard TPN formulas. There are a few commercially-available amino acids with electrolytes solutions; however, these products may not meet an individual's specific nutritional requirements. Consult with nutrition support service to determine adequate formula based upon patient specifics.
Injection, solution [branched chain]:
Aminosyn®-HBC: 7%
BranchAmin®: 4%
FreAmine® HBC: 6.9%
Injection, solution [crystalline]:
Aminosyn®: 3.5%, 5%, 7%, 8.5%, 10%
Aminosyn® ll: 7%, 8.5%, 10%, 15%
Clinisol®: 15%
FreAmine® III: 8.5%, 10%
PremaSol™ : 6%, 10%
Prosol: 20%
Travasol®: 10%
Injection, solution [hepatic]:
Aminosyn®-HF, HepatAmine®, Hepatasol®: 8%
Injection, solution [pediatric]:
Aminosyn®-PF: 7%, 10%
TrophAmine®: 6%, 10%
Injection, solution [renal]:
Aminosyn®-RF: 5.2%
NephrAmine®: 5.4%
Renamin®: 6.5%
ADMINISTRATION — 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.
USE — 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.
ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.
Endocrine & metabolic: Fluid, electrolyte imbalance
Local: Erythema, phlebitis, thrombosis
Renal: Azotemia
CONTRAINDICATIONS — Inborn errors of amino acid metabolism
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: Solutions may contain aluminum; toxic levels may occur following prolonged administration in premature neonates or patients with renal impairment. Sulfites: Some products contain sulfites as preservatives.
Other warning/precautions: Monitoring: Monitor fluid and electrolyte status.
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Excretion in breast milk unknown/use caution
MONITORING PARAMETERS — General patient monitoring during I.V. nutritional therapy
Bone densitometry: Perform upon initiation of long-term therapy.
Efficacy: Nutrition and outcome parameters should be measured serially.
Electrolytes: Sodium, potassium, chloride, and bicarbonate 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.
Line site: Monitor for signs and symptoms of infection.
Liver function tests: Monitor periodically.
Neonates: Sodium, calcium, and phosphate should be monitored closely. Frequent (some advise
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.
CANADIAN BRAND NAMES — Aminosyn; Aminosyn-PF; Aminosyn-RF; Primene®
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