AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER (AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER).
Aminosyn II 3.5% in Dextrose 25% is a combination of amino acids and dextrose for parenteral nutrition. Amino acids provide nitrogen and essential substrates for protein synthesis, while dextrose provides a caloric source to prevent protein catabolism. The mechanism involves infusion into the bloodstream, bypassing gastrointestinal digestion, to maintain or restore nitrogen balance and provide energy.
| Metabolism | Amino acids undergo hepatic metabolism via transamination, deamination, and urea cycle; dextrose is metabolized via glycolysis, citric acid cycle, and oxidative phosphorylation, primarily in the liver and peripheral tissues. |
| Excretion | Renal excretion of amino acids as urea and ammonia; dextrose is metabolized to CO2 and water. Approximately 90% of infused amino nitrogen is recovered in urine as urea within 24 hours. Dextrose is completely metabolized. |
| Half-life | Amino acids have variable half-lives (minutes to hours); dextrose has a plasma half-life of ~2 hours under euglycemic conditions. Clinically, continuous infusion maintains steady state. |
| Protein binding | Amino acids: minimal (<10%) protein binding; dextrose does not bind significantly to plasma proteins. |
| Volume of Distribution | Amino acids: Vd ~0.5 L/kg (total body water); dextrose: Vd ~0.2 L/kg (extracellular fluid). Clinical meaning: distribution reflects body water compartments. |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: Immediate onset for caloric provision and protein synthesis support. |
| Duration of Action | Duration depends on infusion rate; continuous infusion provides sustained effect. Effects cease shortly after discontinuation due to rapid metabolism. |
Intravenous infusion. Amino acid dose based on protein requirements: 0.8-1.0 g/kg/day for stable patients, up to 1.5-2.0 g/kg/day for catabolic states. Dextrose dose based on caloric needs: typically 150-300 g/day. Infuse via central line at rates not exceeding 0.5 g/kg/hour dextrose. Typical starting rate: 50-100 mL/hr, titrated based on metabolic tolerance.
| Dosage form | INJECTABLE |
| Renal impairment | For acute kidney injury (GFR <30 mL/min): reduce amino acid dose to 0.5-0.8 g/kg/day, monitor BUN and electrolytes. For chronic kidney disease: adjust based on protein catabolic rate and dialysis status; GFR 30-60 mL/min: 0.8-1.0 g/kg/day; GFR <30 mL/min: 0.6-0.8 g/kg/day, with essential amino acid supplements if not on dialysis. Dextrose dose adjustment not typically required. |
| Liver impairment | Child-Pugh Class A and B: no specific dose adjustment, but monitor ammonia and fluid status. Child-Pugh Class C (decompensated cirrhosis): reduce amino acid dose to 0.5-0.7 g/kg/day, use branched-chain amino acid enriched formulations if encephalopathy. Dextrose dose may need reduction to avoid hyperglycemia. |
| Pediatric use | Intravenous infusion via central line. Neonates: start at 2-3 g/kg/day amino acids, increase by 0.5-1 g/kg/day to goal 3-4 g/kg/day; dextrose 10-15 mg/kg/min initial, titrate to 20 mg/kg/min. Infants and children: amino acids 1.5-3 g/kg/day, dextrose 10-20 mg/kg/min. Monitor serum glucose, electrolytes, and growth. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER (AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER).
| Breastfeeding | Amino acids and dextrose are endogenous substances normally found in breast milk. No specific M/P ratio available. Considered compatible with breastfeeding when used as nutritional support. |
| Teratogenic Risk | Amino acids and dextrose are essential nutrients; no specific teratogenic risk has been identified. However, high glucose levels may be associated with fetal hyperglycemia and macrosomia. Use with caution in diabetes or gestational diabetes. |
■ FDA Black Box Warning
Not for intravenous administration as a standard infusion. Use only in patients requiring central venous access due to high osmolarity. Risk of hyperglycemia, volume overload, and electrolyte imbalances. Must be used under medical supervision.
| Serious Effects |
Absolute: Known hypersensitivity to any component, severe hyperglycemia, severe hyperlipidemia, inborn errors of amino acid metabolism (e.g., maple syrup urine disease), significant hepatic impairment. Relative: Renal insufficiency, heart failure, fluid overload states.
| Precautions | Risk of infection from central line, hyperglycemia requiring insulin monitoring, fluid overload in renal/cardiac impairment, hepatobiliary complications, electrolyte disturbances, and metabolic acidosis. Monitor serum glucose, electrolytes, liver function, and nitrogen balance. |
| Food/Dietary | No oral food interactions as this is an intravenous formulation. However, when transitioning to oral feeding, coordinate with dietitian to avoid overfeeding or electrolyte imbalances. |
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| Geriatric use | Start at lower end of dosing range. Consider reduced renal function: amino acid dose 0.7-1.0 g/kg/day if GFR ≥60, 0.6-0.8 g/kg/day if GFR <60. Dextrose infusion rate reduce by 20-30% due to higher risk of hyperglycemia. Monitor fluid balance closely due to decreased cardiac reserve. |
| Fetal Monitoring |
| Monitor maternal blood glucose, electrolytes, fluid balance, and renal function. Assess fetal growth and well-being with ultrasound if prolonged use during pregnancy. |
| Fertility Effects | No known adverse effects on fertility. Nutritional support may improve fertility in malnourished women. |
| Clinical Pearls | This formulation is a high-dextrose (25%) amino acid solution for parenteral nutrition, requiring central venous access. Monitor serum glucose, electrolytes, and liver function tests closely. Use with fat emulsion to prevent essential fatty acid deficiency. Adjust infusion rate based on metabolic tolerance to avoid hyperglycemia. Risk of refeeding syndrome in malnourished patients; initiate cautiously with electrolyte monitoring. |
| Patient Advice | This nutrition solution is given through a central vein to provide complete nutrition when you cannot eat. · Report any symptoms of infection at the IV site, such as redness, swelling, or pain. · You will have regular blood tests to check blood sugar, electrolytes, and liver function. · Inform your healthcare provider if you have diabetes, as this solution contains a high amount of sugar. |