AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER (AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER).
Aminosyn II 5% with electrolytes in dextrose 25% provides amino acids for protein synthesis, dextrose for caloric supply, and electrolytes for maintenance of acid-base balance and cellular function. Calcium is included for bone health and neuromuscular function.
| Metabolism | Amino acids are metabolized via deamination, transamination, and urea cycle; dextrose metabolized via glycolysis and oxidative phosphorylation; electrolytes are excreted or utilized as needed. |
| Excretion | Renal: amino acids and dextrose metabolites excreted primarily as urea, CO2, and water; electrolytes excreted renally with fractional excretion varying by individual needs; no significant biliary or fecal elimination. |
| Half-life | Not applicable as a single entity; component amino acids have half-lives ranging from minutes (e.g., alanine) to hours (e.g., branched-chain amino acids); dextrose half-life ~1.5-2 hours in normal glucose metabolism; clinical context: continuous infusion maintains steady state. |
| Protein binding | Minimal for amino acids (<10%) and dextrose (<5%); electrolytes have negligible protein binding; calcium is ~40% bound to albumin and globulins. |
| Volume of Distribution | Amino acids: 0.3-0.5 L/kg (total body water); dextrose: 0.2 L/kg (extracellular water); calcium: 0.2 L/kg (extracellular); overall Vd approximates total body water (~0.6 L/kg). |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: immediate (within seconds) for hemodynamic and metabolic effects; clinical effect (e.g., caloric support) occurs within minutes of initiating infusion. |
| Duration of Action | Intravenous: duration is directly tied to infusion rate and metabolic clearance; effects last as long as infusion continues; after discontinuation, metabolic effects subside within minutes to hours (glucose homeostasis within 1-2 hours). |
Intravenous; initial adult dose 1.0 g/kg/day of amino acids, up to 1.5 g/kg/day; dextrose rate 5 mg/kg/min initially, titrate to 7 mg/kg/min; daily dose adjusted based on metabolic requirements, electrolytes as per serum levels.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-59 mL/min: reduce amino acid dose by 50% (max 0.7 g/kg/day); GFR 15-29 mL/min: reduce to 0.5 g/kg/day; GFR <15 mL/min: contraindicated unless on dialysis, then 0.5-1.0 g/kg/day with monitoring. |
| Liver impairment | Child-Pugh A: reduce amino acid dose by 25% (0.75-1.0 g/kg/day); Child-Pugh B: reduce by 50% (0.5-0.75 g/kg/day), avoid if encephalopathy; Child-Pugh C: contraindicated. |
| Pediatric use | Infants and children: 2-3 g/kg/day of amino acids, dextrose starting at 5-10 mg/kg/min, titrated based on blood glucose; electrolytes as per daily requirements; monitor fluid balance. |
| Geriatric use | Start at lower end of dosing (amino acids 0.8-1.0 g/kg/day, dextrose 3-5 mg/kg/min) due to reduced renal function, monitor electrolytes and fluid balance closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER (AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER).
| Breastfeeding | Excreted in human milk: Unknown. Large molecular weight of amino acids and dextrose likely limits transfer. M/P ratio: Not established. Caution if used during breastfeeding, especially in high doses or prolonged therapy; monitor infant for metabolic disturbances. |
| Teratogenic Risk | Amino acids, dextrose, and electrolytes are considered standard components of parenteral nutrition and are not associated with teratogenic risk when used appropriately. No specific teratogenicity reported. However, underlying maternal conditions requiring this therapy may pose risks. Use in pregnancy only if clearly needed. |
■ FDA Black Box Warning
Not for use in patients with severe electrolyte imbalances, anuria, or in patients with known hypersensitivity to any component. Risk of fluid overload, electrolyte disturbances, and hyperglycemia.
| Serious Effects |
["Hypersensitivity to any component","Severe electrolyte imbalances","Anuria","Hyperglycemia"]
| Precautions | ["Monitor fluid status, serum electrolytes, blood glucose, and renal function frequently","Risk of hyperglycemia, especially in diabetic patients","Risk of electrolyte imbalances, including hypercalcemia","Avoid rapid infusion to prevent fluid overload","Use with caution in patients with cardiac or renal impairment"] |
| Food/Dietary | No oral food interactions apply as this is an intravenous formulation. However, concurrent oral intake (if any) should be managed to avoid overfeeding or electrolyte imbalances. |
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| Fetal Monitoring | Monitor maternal weight, hydration, electrolytes (sodium, potassium, calcium, phosphorus, magnesium), glucose, acid-base status, renal function, and liver function. Fetal monitoring includes ultrasound for growth and amniotic fluid volume, and biophysical profile if indicated. |
| Fertility Effects | No known direct impact on fertility. However, correction of nutritional deficiencies may restore fertility in malnourished women. Use not expected to impair fertility. |
| Clinical Pearls | This combination product provides total parenteral nutrition (TPN) with amino acids, dextrose, electrolytes, and calcium. Monitor serum glucose, electrolytes, and calcium levels closely due to risk of hyperglycemia, hypercalcemia, and electrolyte imbalances. Use with caution in renal impairment, hepatic failure, or metabolic disorders. Central line administration requires strict aseptic technique and confirmation of catheter tip position. Do not administer if precipitate or discoloration is present. |
| Patient Advice | This intravenous solution provides complete nutrition and should only be given under medical supervision. · Report any signs of infection at the catheter site (redness, swelling, pain) or fever immediately. · Tell your doctor if you have symptoms of high blood sugar (increased thirst, urination, confusion) or high calcium (nausea, vomiting, constipation, bone pain). · Regular blood tests are needed to monitor your glucose, electrolytes, and kidney function. · Do not stop or adjust the infusion rate without consulting your healthcare provider. |