AMINOSYN II 10% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN II 10% IN PLASTIC CONTAINER (AMINOSYN II 10% IN PLASTIC CONTAINER).
Aminosyn II 10% is a crystalline amino acid solution that provides essential and nonessential amino acids for protein synthesis, maintenance of nitrogen balance, and tissue repair in parenteral nutrition.
| Metabolism | Amino acids are metabolized via deamination, transamination, and incorporation into proteins. Primarily hepatic metabolism; nitrogen eliminated as urea via kidneys. |
| Excretion | Amino acids are metabolized; excess nitrogen is excreted renally as urea (70-90%) and to a lesser extent in feces (5-10%). |
| Half-life | Variable depending on individual amino acids; typical of infused amino acids: 0.5-2 hours for most, with clinical context of continuous infusion achieving steady-state within 24 hours. |
| Protein binding | Minimal to moderate binding to albumin and other proteins; varies by amino acid (10-40% bound overall); free fraction is readily available. |
| Volume of Distribution | 0.15-0.25 L/kg; reflects distribution into extracellular fluid and uptake into tissues, particularly liver and muscle. |
| Bioavailability | 100% intravenous; not applicable for oral as it is for parenteral use only. |
| Onset of Action | Immediate upon intravenous infusion; amino acids are available for protein synthesis and metabolism within minutes. |
| Duration of Action | Sustained for duration of infusion; transient after discontinuation (minutes to hours) as amino acids are rapidly cleared. |
Intravenous infusion: 7-12 g amino acids per kg body weight per day (0.7-1.2 g/kg/day) for adults with normal renal function; typically administered as a 10% solution at a rate not exceeding 0.5 g amino acids/kg/hour.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR < 50 mL/min: reduce dose to 0.5-0.7 g/kg/day and monitor serum BUN and creatinine; for GFR < 15 mL/min: avoid use or use with extreme caution, considering essential amino acid formulations. |
| Liver impairment | Child-Pugh Class C: avoid use or use with extreme caution, reducing dose by 50% and monitoring ammonia levels; Child-Pugh Class B: reduce dose by 25-50% and monitor for encephalopathy; Child-Pugh Class A: standard dosing with careful monitoring. |
| Pediatric use | Intravenous infusion: neonates and infants: 1-2 g/kg/day initially, increasing to 2-3 g/kg/day as tolerated; children: 1-1.5 g/kg/day up to 2 g/kg/day depending on clinical status; adjust based on growth parameters and metabolic tolerance. |
| Geriatric use | Elderly patients: start at lower end of adult range (0.7-1 g/kg/day) due to decreased renal function; monitor renal function and nitrogen balance; avoid doses >1.2 g/kg/day unless carefully monitored. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN II 10% IN PLASTIC CONTAINER (AMINOSYN II 10% IN PLASTIC CONTAINER).
| Breastfeeding | It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Aminosyn II 10% is administered to a nursing woman. M/P ratio: not available. |
| Teratogenic Risk | Aminosyn II 10% is a amino acid solution used in parenteral nutrition. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Potential fetal risks include electrolyte imbalances and metabolic disturbances if maternal homeostasis is disrupted. Use only if clearly needed and if potential benefits justify potential risks to the fetus. |
■ FDA Black Box Warning
NOT FOR DIRECT INTRAVENOUS INFUSION. Must be admixed with dextrose, electrolytes, vitamins, and possibly lipids before use. Use only in patients with adequate renal function.
| Serious Effects |
["Hypersensitivity to any component","Severe renal impairment (e.g., anuria, dialysis-dependent renal failure)","Severe hepatic impairment with hepatic encephalopathy","Inborn errors of amino acid metabolism (e.g., maple syrup urine disease, phenylketonuria)"]
| Precautions | ["Monitor serum electrolytes, blood urea nitrogen, ammonia, and glucose frequently","Risk of metabolic acidosis, hyperammonemia, and azotemia","Use with caution in renal impairment, hepatic failure, and metabolic disorders","Not for use in patients with inborn errors of amino acid metabolism"] |
| Food/Dietary | No specific food interactions are known, but oral intake should be coordinated with parenteral nutrition to avoid fluid or nutrient overload. Patients on total parenteral nutrition (TPN) should not consume additional oral protein supplements without medical supervision. |
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| Fetal Monitoring | Monitor maternal serum electrolytes, blood glucose, blood urea nitrogen, ammonia, acid-base balance, and liver function tests. Monitor fetal well-being with standard obstetric assessments, including growth scans and nonstress tests if parenteral nutrition is prolonged. |
| Fertility Effects | No specific studies on fertility effects. Use in parenteral nutrition may support metabolic needs in women with reproductive potential, but no known direct adverse effects on fertility. |
| Clinical Pearls | Aminosyn II 10% is a crystalline amino acid solution used for parenteral nutrition. It is contraindicated in patients with inborn errors of amino acid metabolism, severe renal or hepatic disease. Monitor serum electrolyte, blood glucose, and liver function tests regularly. Avoid rapid infusion to prevent hyperglycemia and hyperosmolarity. Use with caution in patients with acid-base imbalances. The solution is compatible with standard lipid emulsions and electrolytes but not with direct addition of medications. |
| Patient Advice | This medication is given through a vein to provide nutrition when you cannot eat or drink enough. · You may need regular blood tests to check your blood sugar, electrolyte levels, and liver function. · Report any signs of infection at the IV site (redness, swelling, pain), fever, chills, or difficulty breathing. · Do not stop treatment abruptly without consulting your healthcare provider. · Inform your doctor if you have kidney disease, liver disease, or diabetes. · This solution contains amino acids; avoid taking additional protein supplements without medical advice. |