AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER (AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER).
Amino acids provide substrates for protein synthesis and metabolic processes; dextrose supplies glucose for energy; electrolytes maintain fluid and electrolyte balance.
| Metabolism | Amino acids undergo deamination and transamination primarily in the liver; dextrose is metabolized via glycolysis, gluconeogenesis, and pyruvate oxidation. |
| Excretion | Renal (amino acids: ~80% reabsorbed, excess excreted unchanged; dextrose: primarily metabolized, small fraction excreted renally <5%; electrolytes: renal excretion proportional to intake and plasma levels). |
| Half-life | Amino acids: 0.5-2 hours (rapid clearance); dextrose: ~1-2 hours (insulin-dependent). Clinical context: Continuous IV infusion maintains steady state. |
| Protein binding | Amino acids: minimal (<10%), mainly albumin; dextrose: negligible; electrolytes: variable (calcium ~40% bound to albumin, magnesium ~30% bound to albumin). |
| Volume of Distribution | Amino acids: 0.2-0.5 L/kg (total body water); dextrose: ~0.2 L/kg (extracellular fluid); electrolytes: variable (sodium ~0.6 L/kg, potassium ~0.4 L/kg, calcium ~0.2 L/kg, magnesium ~0.3 L/kg). |
| Bioavailability | 100% (only IV route; oral bioavailability not applicable as product is specifically for IV use). |
| Onset of Action | Immediate upon IV infusion (caloric support, amino acid provision begins as soon as infused). |
| Duration of Action | Duration equals infusion time; effects cease shortly after discontinuation (blood glucose normalizes within 30-60 min; amino acid levels decline rapidly). |
Intravenous infusion: 500 mL/day initially, titrate to provide 1.5-2 g/kg/day of amino acids and 25-50 g/kg/day of dextrose; monitor electrolytes.
| Dosage form | INJECTABLE |
| Renal impairment | GFR >50: no adjustment. GFR 10-50: use 0.5-1 g/kg/day amino acids. GFR <10: avoid or use with caution, consider specialized renal formulas. |
| Liver impairment | Child-Pugh A: start at 0.5-0.8 g/kg/day amino acids; Child-Pugh B: 0.5-0.6 g/kg/day; Child-Pugh C: avoid or use with extreme caution due to risk of encephalopathy. |
| Pediatric use | Infants and children: intravenous, 2-3 g/kg/day of amino acids, dextrose 10-20% initially, titrate to blood glucose. Monitor fluid and electrolyte balance. |
| Geriatric use | Start at lower end of dosing range (e.g., 0.8-1.2 g/kg/day amino acids), monitor renal function, glucose tolerance, and fluid status due to age-related declines. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER (AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER).
| Breastfeeding | Amino acids and dextrose are endogenous substances normally present in breast milk. No adverse effects expected. M/P ratio not applicable as these are endogenous compounds. Compatible with breastfeeding; use caution with high infusion rates that may affect milk composition. |
| Teratogenic Risk | No known teratogenic effects in humans; amino acids and dextrose are essential nutrients and generally considered safe in pregnancy. However, high glucose levels may be associated with increased risk of congenital anomalies if maternal hyperglycemia occurs. Use only if clearly needed. |
■ FDA Black Box Warning
Not for use in patients with hepatic coma, severe uremia, or maple syrup urine disease due to risk of metabolic disturbances.
| Serious Effects |
["Hypersensitivity to any component","Severe hyperglycemia","Hepatic coma","Severe uremia (pre-dialysis)","Maple syrup urine disease","Inborn errors of amino acid metabolism"]
| Precautions | ["Risk of hyperglycemia and hyperosmolar syndrome; monitor blood glucose and serum osmolarity.","Risk of metabolic acidosis from chloride content; monitor acid-base balance.","Electrolyte abnormalities may occur; monitor serum electrolytes.","Fluid overload risk in renal/cardiac impairment; monitor cardiovascular status.","Aluminum toxicity in prolonged use; risk in renal dysfunction.","Must be used with caution in hepatic or renal disease; may worsen encephalopathy or uremia."] |
| Food/Dietary | None; parenteral administration bypasses the gastrointestinal tract. However, enteral nutrition should not be administered concurrently without medical supervision. |
Loading safety data…
| Fetal Monitoring | Monitor maternal blood glucose, electrolytes, fluid balance, and renal function. Monitor fetal growth and well-being if prolonged use or maternal comorbidities. Assess for signs of fluid overload or metabolic acidosis. |
| Fertility Effects | No known direct effects on fertility. Underlying conditions requiring parenteral nutrition may impact fertility. Use as indicated without specific fertility concerns. |
| Clinical Pearls | Administer via central line due to high dextrose concentration. Monitor serum glucose closely; insulin may be required. Do not administer simultaneously with blood products. Check for incompatibility with other IV medications. Use within 24 hours of spiking container. Assess for signs of phlebitis or infection at insertion site. Renal function and electrolytes must be monitored daily. |
| Patient Advice | This solution provides nutrition through your vein and should not be taken by mouth. · Report any warmth, redness, swelling, or pain at the IV site immediately. · You may need regular blood tests to monitor your blood sugar and electrolyte levels. · Inform your healthcare provider if you have diabetes or any kidney problems. · This product contains dextrose; if you are diabetic, blood sugar monitoring is essential. · Do not alter the infusion rate; it is set to meet your specific nutritional needs. |