AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER (AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER).
Amino acids serve as substrates for protein synthesis and nitrogen balance; dextrose provides caloric energy via glycolysis and oxidative phosphorylation.
| Metabolism | Amino acids undergo transamination, deamination, and oxidation; dextrose is metabolized via glycolysis and the citric acid cycle. |
| Excretion | Aminosyn II 3.5% in Dextrose 5% contains amino acids and dextrose. Amino acids are metabolized; negligible renal excretion of intact amino acids. Dextrose is metabolized. No biliary/fecal elimination of intact drug. |
| Half-life | Not applicable as a mixture; individual components have varying half-lives. Dextrose: rapid distribution, half-life <1 hour. Amino acids: half-life of infused amino acids is short (minutes) due to metabolism. |
| Protein binding | Minimal for amino acids and dextrose; no significant protein binding reported. |
| Volume of Distribution | Not applicable as a mixture; dextrose distributes into total body water (~0.55 L/kg); amino acids distribute into body water compartments (~0.2-0.4 L/kg). |
| Bioavailability | Intravenous only; 100% bioavailability. |
| Onset of Action | Intravenous: immediate upon infusion; metabolic effects commence within minutes. |
| Duration of Action | Duration of action is continuous during infusion; metabolic support persists for hours after cessation depending on metabolic state. |
Intravenous infusion: 1-1.5 g amino acids/kg/day (equivalent to 28-43 mL/kg/day of Aminosyn II 3.5% in D5W). Rate: infuse via central line at ≤100 mL/hour; peripheral line at ≤125 mL/hour. Adjust based on nitrogen balance and metabolic response.
| Dosage form | INJECTABLE |
| Renal impairment | For acute kidney injury or CKD stages 4-5 (eGFR <30 mL/min/1.73m²): restrict amino acids to 0.6-1.0 g/kg/day; monitor BUN and electrolytes. For dialysis patients: 1.0-1.5 g/kg/day. Not recommended for patients with severe renal failure without dialysis. |
| Liver impairment | In hepatic encephalopathy (Child-Pugh class B or C): avoid or use with caution; may require low-protein formulas (0.5-0.7 g/kg/day) with branched-chain amino acid-enriched solutions. Child-Pugh A: standard dosing with monitoring for hyperammonemia. |
| Pediatric use | Neonates and infants: 2.5-3.5 g amino acids/kg/day; titrate based on weight gain and lab values. Children: 1.5-2.0 g/kg/day. Administer via central line with appropriate lipid emulsions and glucose. Monitor electrolyte and acid-base status. |
| Geriatric use | Elderly patients (≥65 years): standard adult dose with careful monitoring for fluid overload, hyperglycemia, and electrolyte imbalances. Start at lower end (1.0 g/kg/day) in frail or malnourished patients; adjust based on renal function and metabolic tolerance. |
| 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 5% IN PLASTIC CONTAINER (AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER).
| Breastfeeding | No specific M/P ratio is available. The components (amino acids, dextrose) are endogenous substances and transfer into breast milk in small amounts; unlikely to cause adverse effects in breastfed infants when used as directed. Caution is advised in mothers with metabolic disorders. |
| Teratogenic Risk | Aminosyn II 3.5% in Dextrose 5% is a parenteral nutrition solution. No teratogenic risk has been established in animal studies; however, electrolyte and metabolic disturbances from underlying maternal conditions may pose fetal risks. During the first trimester, theoretical risks from amino acid imbalances exist; second and third trimester risks are primarily related to maternal metabolic complications such as hyperglycemia or electrolyte derangements. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Patients with inborn errors of amino acid metabolism","Severe hepatic failure with hyperammonemia","Anuria or oliguria","Hypersensitivity to any component"]
| Precautions | ["Risk of fluid overload and electrolyte imbalances","Hyperglycemia in glucose-intolerant patients","Metabolic acidosis with rapid infusion","Aluminum toxicity with prolonged use","Do not administer unless solution is clear and container intact"] |
| Food/Dietary | No direct food interactions, but parenteral nutrition is intended to replace oral intake. If oral intake is resumed, monitor for fluid and electrolyte imbalances. Avoid concurrent use with IV solutions containing calcium unless compatibility confirmed (risk of precipitation). |
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| Fetal Monitoring | Monitor maternal serum electrolytes, blood glucose, acid-base status, renal and hepatic function, and fluid balance. Fetal surveillance includes assessment of growth and well-being via ultrasound and non-stress testing if maternal complications arise. |
| Fertility Effects | No known direct effect on fertility. Uncontrolled maternal malnutrition or metabolic disease may impair ovulation and pregnancy outcomes; correction of nutritional status with parenteral nutrition may improve fertility. |
| Clinical Pearls | Aminosyn II 3.5% in Dextrose 5% is a peripheral parenteral nutrition solution. Administer via central line if hyperosmolar (>900 mOsm/L); this solution is ~700 mOsm/L, suitable for peripheral infusion. Monitor serum electrolytes, glucose, and liver function. Do not use as a sole source of nutrition for prolonged periods; provide lipid emulsion to prevent essential fatty acid deficiency. Check for compatibility with other IV additives. |
| Patient Advice | This solution provides protein and calories to support nutrition when you cannot eat. · Inform your healthcare provider if you have diabetes, kidney disease, or fluid retention. · Report any signs of infection at the IV site (redness, swelling, pain) or difficulty breathing. · This medication is given through a vein; do not stop or adjust the infusion rate yourself. · You may need regular blood tests to monitor your response to this nutrition. |