Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution, Intravenous:
AminoProtect: 5% (1000 mL)
Aminosyn: 8.5% (500 mL [DSC]); 10% (500 mL [DSC], 1000 mL [DSC]) [latex free, sulfite free]
Aminosyn II: 7% (500 mL [DSC]); 8.5% (500 mL [DSC], 1000 mL [DSC]); 10% (2000 mL) [latex free, sulfite free]
Aminosyn II: 10% (500 mL [DSC], 1000 mL [DSC]); 15% (2000 mL) [sulfite free]
Aminosyn II/Electrolytes: 8.5% (500 mL [DSC]) [latex free, sulfite free]
Aminosyn M: 3.5% (1000 mL [DSC]) [latex free, sulfite free]
Aminosyn-HBC: 7% (500 mL [DSC]) [latex free, sulfite free]
Aminosyn-PF: 7% (500 mL); 10% (1000 mL) [latex free, sulfite free]
Aminosyn-RF: 5.2% (500 mL [DSC]) [latex free, sulfite free]
Aminosyn/Electrolytes: 8.5% (500 mL [DSC], 1000 mL [DSC]) [latex free, sulfite free]
Aminosyn/Electrolytes: 7% (500 mL [DSC]) [sulfite free]
Clinimix E/Dextrose (2.75/10): 2.75% (1000 mL [DSC], 2000 mL [DSC]) [sulfite free]
Clinimix E/Dextrose (2.75/5): 2.75% (1000 mL, 2000 mL [DSC]) [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 [DSC], 2000 mL [DSC]) [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 [DSC], 2000 mL [DSC]) [sulfite free]
Clinimix N14G30E: 4.25% (2000 mL [DSC])
Clinimix N9G15E: 2.75% (1000 mL [DSC])
Clinimix N9G20E: 2.75% (1000 mL [DSC])
Clinimix/Dextrose (2.75/5): 2.75% (1000 mL [DSC]) [sulfite free]
Clinimix/Dextrose (4.25/10): 4.25% (1000 mL, 2000 mL) [sulfite free]
Clinimix/Dextrose (4.25/20): 4.25% (1000 mL [DSC], 2000 mL [DSC]) [sulfite free]
Clinimix/Dextrose (4.25/25): 4.25% (1000 mL, 2000 mL [DSC]) [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 [DSC]) [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) [contains sodium bisulfite]
Hepatamine: 8% (500 mL) [contains sodium bisulfite]
NephrAmine: 5.4% (250 mL) [contains sodium bisulfite]
Plenamine: 15% (1000 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)
Synthamin 17: 10% (3000 mL)
Travasol: 10% (500 mL, 1000 mL, 2000 mL) [sulfite free]
Trophamine: 6% (500 mL) [contains acetic acid, sodium metabisulfite]
TrophAmine: 10% (500 mL) [contains sodium metabisulfite]
Pharmacology
Mechanism of Action
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 (eg, maple syrup urine disease, isovaleric acidemia); anuria; hepatic coma (excluding Clinimix, Clinimix E, Hepatamine, Prosol, and Travasol); severe renal failure, metabolic disorders involving impaired nitrogen utilization (excluding Aminosyn-PF, Clinimix, Clinimix E, FreAmine, Hepatamine, Prosol, Travasol, and TrophAmine); pulmonary edema or acidosis due to low cardiac output (Clinimix, Clinimix E, and Travasol); neonates (<28 days of age) receiving concomitant ceftriaxone (Clinimix E). Note: Contraindications 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)
Dosage and Administration
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
CRRT: 1.2 to 1.8 g/kg/day (maximum: 2.5 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, 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
Administration
IV: Administered as a component of peripheral parenteral or total parenteral nutrition. Central or peripheral administration of nutrition is dependent upon osmolality of solution. Solutions with >5% dextrose or osmolarity ≥900 mOsm/L must be infused via central venous catheter. 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; Reynolds 2014); elevate extremity.
Hyaluronidase: Intradermal or SubQ: Inject a total of 1 to 1.7 mL (15 units/mL) as five separate 0.2 to 0.3 mL injections (using a 25-gauge needle) into area of extravasation at the leading edge in a clockwise manner (MacCara 1983; Reynolds 2014; Zenk 1981).
Storage
Store intact (unopened) containers at 20°C to 25°C (68°F to 77°F); avoid excessive heat; do not freeze. Protect from light. Refer to manufacturer's labeling for additional storage information.
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:
- 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 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.
- 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.
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); signs/symptoms of hypersensitivity reaction; vitamin A status (in patients with chronic renal failure). Monitor infusion site.
Pregnancy
Pregnancy Considerations
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).
Patient Education
What is this drug used for?
- It is used to give nutrition to the body.
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, abnormal heartbeat, severe dizziness, passing out, fast heartbeat, increased thirst, seizures, loss of strength and energy, lack of appetite, unable to pass urine or change in amount of urine passed, dry mouth, dry eyes, or nausea or vomiting
- High ammonia like abnormal heartbeat, trouble breathing, confusion, pale skin, slow heartbeat, seizures, vomiting, sweating a lot, or twitching
- Liver problems like dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin
- Severe headache
- Severe dizziness
- Passing out
- Vision changes
- Blue/gray skin discoloration
- Sweating a lot
- Shortness of breath
- Excessive weight gain
- Swelling of arms or legs
- Chest pain
- Coughing up blood
- Chills
- Severe injection site redness, burning, pain, swelling, or irritation
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
