AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER (AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER).
Amino acids provide substrates for protein synthesis, counteract negative nitrogen balance, and maintain muscle mass. Dextrose supplies calories for energy metabolism, and electrolytes correct or prevent imbalances.
| Metabolism | Amino acids are metabolized via transamination, deamination, and oxidation; dextrose undergoes glycolysis and oxidative metabolism; electrolytes are absorbed and utilized by various organs. |
| Excretion | Urea (from amino acid metabolism) is excreted renally. Electrolytes and dextrose metabolites are eliminated via renal and respiratory routes. No significant biliary/fecal elimination. |
| Half-life | Variable; amino acids have half-lives of minutes to hours depending on metabolic demand and renal function. Dextrose has a half-life of 15-20 minutes under normal conditions. In renal impairment, half-life of amino acid byproducts may prolong. |
| Protein binding | Amino acids are not significantly protein-bound (low binding to albumin). Dextrose and electrolytes show negligible protein binding. Overall <5% bound. |
| Volume of Distribution | Amino acids distribute to total body water (Vd ~0.5-0.7 L/kg). Dextrose distributes primarily to extracellular fluid (Vd ~0.2 L/kg). Electrolytes distribute according to their specific compartments. |
| Bioavailability | Not applicable; only intravenous administration is intended. Bioavailability is 100% via IV infusion. |
| Onset of Action | Immediate upon intravenous infusion; metabolic effects begin within minutes as amino acids and dextrose enter circulation. |
| Duration of Action | Duration depends on infusion rate and metabolic utilization; continuous infusion maintains steady state. Effects persist as long as infusion continues. Post-infusion, metabolic effects decline over hours. |
1-2 L/day intravenously, infused at a rate of 1-2 mL/kg/hour (50-100 mL/hour) for a 70 kg adult, adjusted based on nitrogen and caloric needs.
| Dosage form | INJECTABLE |
| Renal impairment | In acute kidney injury (GFR <30 mL/min), avoid use or reduce to 0.5-1 L/day with close monitoring of electrolytes and acid-base status. In chronic kidney disease (GFR 30-60 mL/min), use with caution and reduce dose by 25-50%. |
| Liver impairment | In Child-Pugh B or C cirrhosis, reduce dose by 50% and consider using a branched-chain amino acid enriched formulation. Avoid in hepatic encephalopathy. |
| Pediatric use | Weight-based: 2-3 g/kg/day of amino acids, with dextrose at 10-20% concentration. Example for a 20 kg child: 400-600 mL/day of this formulation (providing 4.25% amino acids and 20% dextrose) at 20-30 mL/hour. |
| Geriatric use | Start at lower end of adult dose (0.5-1 L/day) and titrate based on renal function, fluid status, and electrolyte balance. Monitor for fluid overload due to decreased cardiovascular reserve. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER (AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER).
| Breastfeeding | Aminosyn II components are endogenous substances found in breast milk. Dextrose and amino acids are normally present; calcium and electrolytes are essential. M/P ratio not established. Parenteral nutrition (PN) is not absorbed intact by the infant; maternal PN does not lead to significant drug exposure. However, maternal hyperglycemia or electrolyte disturbances may affect milk composition. Use is considered compatible with breastfeeding, but monitor infant for electrolyte disturbances if maternal imbalances occur. |
| Teratogenic Risk |
■ FDA Black Box Warning
Not for use in patients with severe hepatic disease, severe uremia, or maple syrup urine disease. Risk of metabolic acidosis, hyperammonemia, and electrolyte imbalances. Do not administer if precipitate is present.
| Serious Effects |
Hypersensitivity to any component; severe hepatic disease; severe uremia; maple syrup urine disease; hyperglycemia or hyperosmolar coma; pulmonary edema or anuria.
| Precautions | Monitor fluid and electrolyte balance, blood glucose, serum ammonia, and renal function. Use with caution in patients with heart failure, renal impairment, or diabetes. Avoid rapid infusion to prevent hyperglycemia and osmotic diuresis. |
| Food/Dietary | No direct food interactions as this is administered intravenously. However, oral intake should be monitored and adjusted per clinical status. Avoid concurrent oral calcium supplements unless prescribed. |
Loading safety data…
| Aminosyn II 4.25% with electrolytes in dextrose 20% with calcium is a parenteral nutrition solution. The individual components are not teratogenic at standard doses, but maternal acidosis, electrolyte imbalances, or hyperglycemia (from dextrose) may pose risks. In trimester 1, severe hyperglycemia may increase risk of neural tube defects; in trimesters 2 and 3, uncontrolled maternal diabetes may cause macrosomia, polyhydramnios, and neonatal hypoglycemia. Calcium-containing TPN may cause hypercalcemia, which is teratogenic at high levels (e.g., cardiac defects). Balanced, monitored use is not associated with major teratogenic risk. |
| Fetal Monitoring | Monitor maternal glucose, electrolytes (Na, K, Cl, Ca, Mg, P), serum osmolarity, acid-base status, and liver function. In pregnancy, additional monitoring: fetal growth via ultrasound (for hyperglycemia/macrosomia), fetal heart rate monitoring if maternal acidosis or electrolyte disturbances occur. Frequent BUN/creatinine, urine glucose/ketones. Adjust PN components based on lab results. |
| Fertility Effects | Aminosyn II 4.25% with electrolytes in dextrose 20% with calcium: No direct effect on fertility. Adequate nutrition supports normal reproductive function. However, severe malnutrition or metabolic disturbances corrected by PN may improve fertility. No adverse effects on spermatogenesis or oogenesis reported. Use of calcium at high doses may impair implantation in animal studies, but clinical relevance is low. |
| Clinical Pearls | This is a parenteral nutrition solution providing amino acids (4.25%), electrolytes, and dextrose (20%) with added calcium. Monitor serum electrolytes, glucose, and renal function closely. Do not administer if calcium and phosphate product exceeds 72 mg^2/dL^2 to avoid precipitation. Use inline filter (1.2 micron) for lipid-containing PN. Adjust rate gradually to prevent hyperglycemia. Not for peripheral administration due to high osmolarity (~1500 mOsm/L). |
| Patient Advice | This medication is given through a vein and provides complete nutrition when you cannot eat. · Report any signs of infection around the IV site (redness, swelling, pain) or fever. · Tell your healthcare team if you have trouble breathing, swelling in your legs, or rapid weight gain. · Do not change the infusion rate or stop it without consulting your doctor. · Regular blood tests are needed to monitor your glucose, electrolytes, and liver function. |