AMINOSYN 3.5% W/ DEXTROSE 5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN 3.5% W/ DEXTROSE 5% IN PLASTIC CONTAINER (AMINOSYN 3.5% W/ DEXTROSE 5% IN PLASTIC CONTAINER).
Aminosyn 3.5% w/ Dextrose 5% provides essential and non-essential amino acids for protein synthesis and dextrose for caloric support, aiding in nitrogen balance and maintenance of lean body mass in parenteral nutrition.
| Metabolism | Amino acids are metabolized via deamination, transamination, and incorporation into proteins; dextrose is metabolized via glycolysis, the citric acid cycle, and oxidative phosphorylation. |
| Excretion | Renal excretion of amino acids and dextrose metabolites (CO2, water). Urea nitrogen accounts for ~80-90% of nitrogen excretion. Unchanged dextrose minimal (<1%). Biliary/fecal excretion negligible. |
| Half-life | Not applicable as a single entity; amino acids and dextrose are endogenous substances. Metabolic half-life of infused amino acids ~10-30 min; dextrose ~15-20 min. Continuous infusion results in steady state. |
| Protein binding | Minimal (<10%) for amino acids; dextrose not protein bound. |
| Volume of Distribution | Amino acids distribute into total body water (~0.45-0.55 L/kg); dextrose primarily extracellular fluid (~0.15-0.20 L/kg). |
| Bioavailability | 100% IV; not administered via other routes. |
| Onset of Action | Immediate upon IV infusion; nitrogen balance improvement within hours. |
| Duration of Action | Duration equals infusion period; metabolic effects persist for 30-60 min post-infusion due to rapid clearance. |
Intravenous infusion. Adult dose: 500-1000 mL per day, infused at a rate not exceeding 100 mL/hour, adjusted based on metabolic requirements and tolerance.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in severe renal impairment (GFR <25 mL/min). For GFR 25-50 mL/min: reduce dose by 50%. Monitor serum electrolytes and fluid status closely. |
| Liver impairment | Contraindicated in severe hepatic insufficiency (Child-Pugh class C). For Child-Pugh class B: reduce dose to 50% and monitor ammonia levels. No adjustment for Child-Pugh class A. |
| Pediatric use | Weight-based dosing: 2-3 g/kg/day of amino acids (equivalent to 57-86 mL/kg/day of this product) as part of parenteral nutrition. Adjust based on metabolic response and tolerance. Infusion rate: not to exceed 0.1 g/kg/hour of amino acids. |
| Geriatric use | No specific dose adjustment, but caution due to potential renal impairment. Monitor fluid and electrolyte balance closely. Use the lowest effective dose and adjust based on renal function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN 3.5% W/ DEXTROSE 5% IN PLASTIC CONTAINER (AMINOSYN 3.5% W/ DEXTROSE 5% IN PLASTIC CONTAINER).
| Breastfeeding | It is not known whether this solution is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when administered to a nursing woman. The M/P ratio has not been determined. Use during lactation is likely safe when indicated for maternal nutritional support, but individual assessment is recommended. |
| Teratogenic Risk | Aminosyn 3.5% w/ dextrose 5% is an amino acid and carbohydrate solution. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. In general, intravenous amino acid and dextrose solutions are used as part of parenteral nutrition and are considered essential for maternal and fetal nutritional support when oral intake is inadequate. The risk of teratogenicity is likely low, but specific trimester risks are unknown. Use only if clearly needed and potential benefits justify potential risks. |
■ FDA Black Box Warning
This product contains aluminum that may be toxic; aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk.
| Serious Effects |
Hypersensitivity to any component, severe electrolyte imbalances, severe liver disease with impending coma (hepatic encephalopathy), inborn errors of amino acid metabolism, and severe renal impairment without adequate dialysis.
| Precautions | Monitor for fluid and electrolyte imbalances, hyperglycemia, hyperosmolarity, azotemia, and hyperammonemia. Use with caution in patients with renal impairment, hepatic disease, or congestive heart failure. Do not administer simultaneously with blood products through the same infusion line. |
| Food/Dietary | No specific food interactions. Enteral nutrition should be avoided if parenteral nutrition is being used as primary source. Monitor glucose if patient is on carbohydrate-containing diets. |
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| Fetal Monitoring | Monitor maternal serum electrolytes, blood glucose, fluid balance, renal function, and liver function throughout therapy. In pregnancy, additional monitoring of maternal weight gain, fetal growth (via ultrasound), and amniotic fluid volume may be necessary. Monitor for signs of hyperglycemia, electrolyte imbalances, and fluid overload. In neonates, monitor for hypoglycemia if maternal glucose levels are high. |
| Fertility Effects | No studies have been conducted on fertility effects of Aminsyn 3.5% w/ dextrose 5%. The solution is intended for nutritional support and is not expected to adversely affect fertility when used as directed. However, underlying conditions requiring parenteral nutrition may impact fertility. |
| Clinical Pearls | Aminosyn 3.5% with Dextrose 5% is a peripheral parenteral nutrition solution that provides 3.5% amino acids and 5% dextrose. It is not suitable for central line administration due to low osmolality (~560 mOsm/L). Monitor serum electrolytes, renal function, and blood glucose closely. Avoid rapid infusion to prevent hyperglycemia and osmotic diuresis. Use with caution in patients with renal or hepatic impairment. |
| Patient Advice | This medication is given intravenously to provide nutrition when you cannot eat or drink normally. · Inform your healthcare provider about any allergies, especially to amino acids or dextrose. · Report any signs of infection at the IV site (redness, swelling, pain) or difficulty breathing. · Your blood sugar and electrolyte levels will be monitored regularly during treatment. · Do not stop the infusion abruptly without medical advice. |