Version May 2024
Note: Correct severe fluid, electrolyte, and acid-base disorders prior to administration.
Component of parenteral nutrition: Protein provided as amino acids (Ref):
Stable: IV: 0.8 to 1.5 g/kg/day.
Critically ill, trauma, or sepsis: IV: 1.2 to 2.5 g/kg/day.
Traumatic brain injury: IV: 1.5 to 2.5 g/kg/day.
Burn patients: IV: 1.5 to 2 g/kg/day.
Open abdomen: IV: Add an additional 15 to 30 g/L of exudate.
Use with caution in patients with renal impairment; dosage adjustment may be necessary. Some products are contraindicated in patients with severe renal failure.
Acute kidney injury: IV: 0.8 to 2 g/kg/day (Ref).
Chronic kidney failure with maintenance hemodialysis: IV: 1.2 g/kg/day (Ref).
CRRT: IV: Add an additional 0.2 g/kg/day; maximum daily dose: 2.5 g/kg/day (Ref).
Use with caution in patients with hepatic impairment; dosage adjustments may be necessary. Some products are contraindicated in patients in hepatic coma.
Hepatic failure: IV: 1.2 to 2 g/kg/day (based on ‘dry’ weight and tolerance) (Ref).
IV: 2 to 2.5 g/kg/day (based on ideal body weight) (Ref).
Refer to adult dosing.
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, Prosol, Travasol:
Infants <1 month of age: 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
Use with caution in patients with renal impairment; dosage adjustment may be necessary. Some products are contraindicated in patients with severe renal failure.
Use with caution in patients with hepatic impairment; dosage adjustments may be necessary. Some products are contraindicated in patients in hepatic coma.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.
Cardiovascular: Phlebitis, thrombosis
Dermatologic: Erythema
Endocrine & metabolic: Fluid and electrolyte disturbance
Genitourinary: Azotemia
Hypersensitivity to one or more amino acids, dextrose, or any component of the formulation; inborn errors of amino acid metabolism (eg, maple syrup urine disease, isovaleric acidemia); neonates (<28 days of age) receiving concomitant ceftriaxone (Clinimix E); simultaneous administration of ceftriaxone through the same infusion line in patients >28 days of age (Clinimix-E); however, contraindications may vary per manufacturer labeling (refer also to specific product labeling).
Canadian labeling: Additional contraindications (not in US labeling): Note: Contraindications vary per manufacturer labeling (refer also to specific product labeling): Acute renal failure and without undergoing renal replacement therapy; severe liver failure; severe hyperglycemia (ie, glucose ≥180 mg/dL); simultaneous administration of ceftriaxone through the same infusion line in patients >28 days of age; hypernatremia; hyperkalemia; hypercalcemia; hyperphosphatemia; hypermagnesemia; coadministration with calcium-containing intravenous solutions; azotemia from any cause (if not accounting for total nitrogen intake)
Concerns related to adverse effects:
• Extravasation: Vesicant; ensure proper catheter or needle position prior to and during infusion. Avoid extravasation.
• Hepatobiliary effects: Hepatobiliary disorders (eg, cholecystitis, cholelithiasis, cholestasis, cirrhosis, hepatic steatosis, fibrosis) may occur in patients without liver disease and may lead to hepatic failure. Increase in blood ammonia levels and hyperammonemia may also occur. Consider discontinuation or dose reduction in patients who develop abnormal LFTs.
• Hyperammonemia: Asymptomatic hyperammonemia has been reported. Infants are especially at risk; monitor blood ammonia levels frequently in infants. Discontinue use with symptoms of hyperammonemia.
• 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 dehydration, resulting in a transient reduction in GFR and prerenal azotemia, 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.
• Infection: Patients requiring parenteral nutrition may be at high risk of infection, including sepsis, due to malnutrition, the underlying disease state, or catheters required for administration. Proper aseptic technique should be followed; monitor for signs of early infection. Diabetic patients are at a greater risk of developing catheter-related infections compared with nondiabetic patients (McMahon 1996). Consider antifungal prophylaxis in patients receiving parenteral nutrition in ICUs with high rates (>5%) of invasive candidiasis (IDSA [Pappas 2016]).
• Parenteral nutrition–associated liver disease: Has been reported in patients receiving parenteral nutrition for extended periods of time, especially preterm infants. Parenteral nutrition–associated liver disease may present as cholestasis or steatohepatitis. Consider discontinuation or dose reduction in patients who develop liver function test abnormalities.
• 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; may result in amino acid imbalances, hyperammonemia, prerenal azotemia, stupor, and coma; dosage adjustments may be necessary. Consider volume status in patients with hepatic failure, may require concentrated total parenteral nutrition formula.
• Pulmonary disorders: Use with caution in patients with pulmonary congestion; these patients are susceptible to excessive fluid accumulation.
• 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. Administration of amino acids in patients with impaired renal function may augment an increase in BUN. 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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous:
AminoProtect: 5% (1000 mL)
Aminosyn II: 10% (2000 mL); 15% (2000 mL) [sulfite free]
Aminosyn-PF: 7% (500 mL [DSC]) [latex free, sulfite free]
Aminosyn-PF: 10% (1000 mL) [sulfite free]
Aminosyn-PF 7%: 7% (500 mL) [sulfite free]
Clinimix E/Dextrose (2.75/5): 2.75% (1000 mL) [sulfite free]
Clinimix E/Dextrose (4.25/10): 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 (8/10): 8% (1000 mL, 2000 mL) [sulfite free]
Clinimix E/Dextrose (8/14): 8% (1000 mL, 2000 mL) [sulfite free]
Clinimix/Dextrose (4.25/10): 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 (6/5): 6% (1000 mL) [sulfite free]
Clinimix/Dextrose (8/10): 8% (1000 mL, 2000 mL) [sulfite free]
Clinimix/Dextrose (8/14): 8% (1000 mL, 2000 mL) [sulfite free]
Clinisol SF: 15% (500 mL, 2000 mL) [sulfite free]
FreAmine HBC: 6.9% (750 mL) [contains sodium bisulfite]
FreAmine III: 10% (1000 mL [DSC]) [contains sodium bisulfite]
Plenamine: 15% (1000 mL, 2000 mL)
Plenamine: 15% (1000 mL) [contains sodium metabisulfite]
Premasol: 10% (500 mL, 1000 mL, 2000 mL) [sulfite free]
Prosol: 20% (2000 mL)
Travasol: 10% (500 mL, 1000 mL, 2000 mL) [sulfite free]
TrophAmine: 10% (500 mL)
TrophAmine: 10% (500 mL [DSC]) [contains sodium metabisulfite]
Yes
Solution (Aminosyn II Intravenous)
10% (per mL): $0.02
15% (per mL): $0.03
Solution (Aminosyn-PF 7% Intravenous)
7% (per mL): $0.09
Solution (Aminosyn-PF Intravenous)
10% (per mL): $0.08
Solution (Clinimix E/Dextrose (2.75/5) Intravenous)
2.75% (per mL): $0.05
Solution (Clinimix E/Dextrose (4.25/10) Intravenous)
4.25% (per mL): $0.06
Solution (Clinimix E/Dextrose (4.25/5) Intravenous)
4.25% (per mL): $0.05
Solution (Clinimix E/Dextrose (5/15) Intravenous)
5% (per mL): $0.05
Solution (Clinimix E/Dextrose (5/20) Intravenous)
5% (per mL): $0.05
Solution (Clinimix/Dextrose (4.25/10) Intravenous)
4.25% (per mL): $0.05
Solution (Clinimix/Dextrose (4.25/5) Intravenous)
4.25% (per mL): $0.05
Solution (Clinimix/Dextrose (5/15) Intravenous)
5% (per mL): $0.05
Solution (Clinimix/Dextrose (5/20) Intravenous)
5% (per mL): $0.05
Solution (Clinisol SF Intravenous)
15% (per mL): $0.24
Solution (Plenamine Intravenous)
15% (per mL): $0.05
Solution (Premasol Intravenous)
10% (per mL): $0.12
Solution (Prosol Intravenous)
20% (per mL): $0.08
Solution (Travasol Intravenous)
10% (per mL): $0.04
Solution (TrophAmine Intravenous)
10% (per mL): $0.09
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous:
Aminosyn II 10%: 10% ([DSC])
Aminosyn II 15%: 15% ([DSC])
Clinimix E/Dextrose (5/10): 5% (1000 mL, 2000 mL)
Clinimix E/Dextrose (5/16.6): 5% (1000 mL, 2000 mL)
Clinimix E/Dextrose (5/20): 5% (1000 mL)
Clinimix/Dextrose (5/10): 5% (1000 mL, 2000 mL)
Clinimix/Dextrose (5/16.6): 5% (100 mL, 1000 mL, 2000 mL)
Clinimix/Dextrose (5/20): 5% (1000 mL)
Clinimix/Dextrose (5/5): 5% (1000 mL)
Hepatamine: 8% (500 mL)
Primene: 10% (250 mL)
Prosol 20%: 20% (500 mL, 1000 mL, 2000 mL)
Travasol: 10% (3000 mL)
Generic: 8% (1000 mL, 2000 mL)
IV: Administered as a component of parenteral nutrition. Central or peripheral administration of parenteral nutrition is dependent upon osmolality of the admixture/solution. Parenteral nutrition with >5% dextrose or osmolarity ≥900 mOsm/L must be infused via central venous catheter. Peripheral parenteral nutrition or protein-sparing therapy may be administered via peripheral venous access. May require use of inline filter (consult specific product labeling and/or individual institutional policies and procedures) (Ref). Initiation and termination of parenteral nutrition 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; leave needle/cannula in place temporarily but do NOT flush the line; gently aspirate extravasated solution, then remove needle/cannula; elevate extremity; apply dry cold compresses; initiate hyaluronidase antidote (Ref).
Hyaluronidase: Intradermal or SUBQ: Inject a total of 1 mL (15 units/mL) as five separate 0.2 mL injections (using a tuberculin syringe) around the site of extravasation; if IV catheter remains in place, administer IV through infiltrated catheter; may repeat in 30 to 60 minutes if no resolution (Ref).
IV: Administered intravenously 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. 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 (see Management of Drug Extravasations for more details); remove needle/cannula; apply dry cold compresses (Ref); elevate extremity.
Component of parenteral nutrition: As part of parenteral nutrition in patients who are malnourished or when oral and/or enteral nutrition is not possible, insufficient, or contraindicated. Specialty amino acid formulas may be considered in certain instances.
TrophAmine may be confused with tromethamine
Following administration, an increase of some amino acids is observed in the fetus (Ronzoni 1999; Ronzoni 2002).
Severe malnutrition during pregnancy is associated with congenital malformation, preterm delivery, low birth weight/intrauterine growth restriction, and perinatal mortality. Parenteral nutrition should be considered when nutritional requirements cannot be met via oral or enteral intake during pregnancy. In women with nausea and vomiting of pregnancy, total 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 189 2018).
Endogenous amino acids are present in breast milk (IOM 1991). According to the manufacturer, the decision to continue or discontinue breastfeeding during therapy should take into account the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother.
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); signs/symptoms of hypersensitivity reaction; vitamin A status (in patients with chronic renal failure). Monitor infusion site.
Preservation or recovery of the lean body mass is related to improved outcomes in parenteral nutrition patients. Protein (amino acids) are essential to parenteral nutrition improvement of lean body mass. Measures to monitor for lean body mass include nitrogen balance or various methods of body composition (ultrasonography, CT scan, or multifrequency bioimpedance) (Hurt 2017). Other measures include wound healing, stamina, functional status, progress toward weight gain or growth goals (Worthington 2017).
Promote protein synthesis and wound healing, and reduce the rate of endogenous protein catabolism.
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