AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER (AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER).
Aminosyn II 4.25% M in Dextrose 10% is a combination of amino acids and dextrose used for parenteral nutrition. Amino acids provide substrates for protein synthesis, while dextrose provides a source of calories. The amino acids undergo transamination, deamination, and incorporation into body proteins. Dextrose is metabolized via glycolysis, the Krebs cycle, and oxidative phosphorylation to produce ATP.
| Metabolism | Amino acids are metabolized primarily in the liver via transamination, deamination, and urea cycle. Dextrose is metabolized in all tissues via glycolysis and the Krebs cycle. Insulin regulates glucose uptake and utilization. |
| Excretion | Renal: amino acids are metabolized and nitrogen is excreted primarily as urea (80-90%) and ammonia (minor); dextrose is fully metabolized to CO2 and water; negligible biliary/fecal elimination. |
| Half-life | Amino acids: variable; individual amino acid half-lives range from minutes to hours; dextrose: 1-2 hours; clinical context: continuous infusion required to maintain stable plasma levels. |
| Protein binding | Amino acids: minimal (5-10%) bound to albumin; dextrose: negligible protein binding. |
| Volume of Distribution | Amino acids: total body water (0.5-0.7 L/kg); dextrose: initial volume approximates plasma volume (0.05 L/kg) then distributes to total body water; clinical meaning: extensive distribution into all body tissues. |
| Bioavailability | Intravenous: 100% bioavailable; not administered via other routes. |
| Onset of Action | Intravenous: immediate (within minutes) for nutrient availability; clinical effect (nitrogen balance improvement) occurs within 24-48 hours of continuous infusion. |
| Duration of Action | Intravenous: duration depends on infusion rate; continuous infusion provides sustained effect; typical infusion period 12-24 hours; clinical effect persists as long as infusion continues. |
Intravenous infusion via central line. Adult dose: 500-2000 mL/day (equivalent to 21.25-85 g amino acids and 50-200 g dextrose) based on caloric and nitrogen requirements. Rate not to exceed 100 mL/hour initially, adjusted to maintain blood glucose <200 mg/dL.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR <50 mL/min/1.73 m²: Reduce total daily dose by 50-75% and monitor serum electrolytes and pH. For GFR <15 mL/min/1.73 m²: Use with caution, may require essential amino acid formulation; avoid if severe hyperkalemia or acidosis. |
| Liver impairment | Child-Pugh class B or C: Use with caution; reduce amino acid dose to 0.5-0.8 g/kg/day to prevent hepatic encephalopathy. Monitor ammonia levels. |
| Pediatric use | Weight-based: For full-term infants and children, initial dose: 1-2 g amino acids per kg per day, titrated to a maximum of 3-4 g/kg/day. Dextrose may be adjusted to maintain euglycemia. Administer via central line. |
| Geriatric use | No specific dose adjustment recommended, but start at lower end of adult dosing range (250-500 mL/day). Monitor renal function, fluid balance, and blood glucose closely due to higher risk of renal impairment and glucose intolerance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER (AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER).
| Breastfeeding | There is no information on the excretion of Aminosyn II or Dextrose into human milk. The M/P ratio is not available. Parenteral nutrition components are generally considered compatible with breastfeeding, as they are identical to endogenous nutrients. However, the clinical need for the mother and the potential for adverse effects on the nursing infant should be considered. |
| Teratogenic Risk | Aminosyn II 4.25% M in Dextrose 10% is a combination of amino acids and dextrose used for parenteral nutrition. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. As with all parenteral nutrition, use during pregnancy should be based on the mother's nutritional deficit and clinical need, with careful monitoring of maternal and fetal status. No specific teratogenic effects have been identified, but the risk cannot be ruled out. |
■ FDA Black Box Warning
This product is not intended for use in patients with anuria, severe electrolyte imbalances, or in those with a history of hypersensitivity to any component. Risk of hyperglycemia, hyperosmolar coma, and metabolic acidosis. Do not administer unless solution is clear and container is undamaged.
| Serious Effects |
["Anuria","Severe electrolyte imbalances","Hypersensitivity to any component","Severe metabolic acidosis","Pulmonary edema","Uncontrolled hyperglycemia"]
| Precautions | ["Monitor serum electrolytes, blood glucose, fluid balance, and liver function regularly","Risk of infection due to indwelling catheter; use strict aseptic technique","Potential for hyperglycemia, especially in diabetic or stressed patients","Risk of refeeding syndrome in malnourished patients","Do not use if solution is discolored, turbid, or contains particulate matter","Use with caution in patients with renal impairment, hepatic disease, or metabolic disorders"] |
| Food/Dietary | No specific food interactions for intravenous administration. However, patients transitioning to oral/enteral nutrition should coordinate with dietary guidelines. Avoid alcohol due to risk of hypoglycemia and liver strain. |
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| Fetal Monitoring | Monitor maternal serum electrolytes, blood glucose, fluid balance, and renal function. Fetal growth and well-being should be assessed via ultrasound and non-stress testing as clinically indicated. Watch for signs of maternal metabolic complications (e.g., hyperglycemia, electrolyte imbalances) that could affect the fetus. |
| Fertility Effects | No studies have been conducted on fertility effects. There is no known adverse impact on reproductive function from the amino acids and dextrose present at typical parenteral nutrition doses. |
| Clinical Pearls | This formulation provides 4.25% amino acids and 10% dextrose, yielding approximately 0.57 kcal/mL. It is indicated for parenteral nutrition when oral/enteral intake is inadequate. Avoid use in patients with severe electrolyte abnormalities, hepatic encephalopathy, or inborn errors of amino acid metabolism. Monitor for hyperglycemia, azotemia, and electrolyte imbalances. Do not administer simultaneously with blood products via same IV line. |
| Patient Advice | This solution is given through a vein to provide nutrition when you cannot eat. · You may experience increased urination, thirst, or changes in blood sugar. · Report any signs of infection (fever, chills) or vein irritation (redness, swelling, pain at IV site). · Your doctor will monitor your blood sugar, electrolytes, and kidney function regularly. · Do not stop or adjust the infusion rate on your own. |