AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER (AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER).
Amino acids serve as substrates for protein synthesis and nitrogen balance; dextrose provides caloric energy. Dextrose stimulates insulin release, promoting cellular uptake of amino acids.
| Metabolism | Amino acids are metabolized via transamination, deamination, and urea cycle in the liver; dextrose undergoes glycolysis and oxidative phosphorylation. |
| Excretion | Amino acids are primarily metabolized; nitrogen is excreted as urea (renal, ~85%) and ammonia (renal, ~2-5%); glucose is fully metabolized to CO2 and water (exhaled and renal); electrolytes are excreted renally. Less than 5% excreted unchanged renally. |
| Half-life | Not applicable as a single entity; amino acids have rapid plasma clearance (t1/2 of minutes to hours) and dextrose is rapidly cleared (t1/2 ~1-2 hours). Clinical context: Continuous infusion maintains steady state. |
| Protein binding | Amino acids: variable (e.g., tryptophan ~90% bound to albumin; others <20%). Dextrose: negligible (<5%). Overall minimal. |
| Volume of Distribution | Amino acids distribute into total body water (~0.6 L/kg); dextrose distributes into extracellular fluid (~0.2 L/kg). Overall Vd ~0.4-0.6 L/kg. |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: Immediate upon infusion; restoration of amino acid levels and glucose utilization begins within minutes. |
| Duration of Action | Duration is dependent on infusion rate and metabolic demand. Clinical note: Must be continuously infused; effects last only as long as infusion continues. |
Intravenous administration based on protein requirements: 1.0-2.0 g/kg/day amino acids, corresponding to 20-40 mL/kg/day of AMINOSYN II 5% in DEXTROSE 25%. Typical adult dose starts at 30-40 mL/hour, titrated to metabolic goals.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-59 mL/min: reduce to 0.8-1.2 g/kg/day amino acids. GFR 15-29 mL/min: 0.6-0.8 g/kg/day. GFR <15 mL/min: 0.6 g/kg/day or avoid if not on dialysis. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce to 0.8-1.2 g/kg/day amino acids. Child-Pugh C: 0.6-0.8 g/kg/day, consider branched-chain amino acid formulations. |
| Pediatric use | Neonates: 2.0-3.5 g/kg/day amino acids (40-70 mL/kg/day). Infants: 1.5-3.0 g/kg/day (30-60 mL/kg/day). Children: 1.0-2.0 g/kg/day (20-40 mL/kg/day). Administer intravenous. |
| Geriatric use | No specific dose adjustment; monitor renal function and fluid status. Start at lower end of adult range (1.0-1.5 g/kg/day amino acids) and titrate based on tolerance and metabolic response. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER (AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER).
| Breastfeeding | No data on excretion of Aminosyn II 5% or dextrose 25% in human milk. Dextrose is a normal component of breast milk; amino acids are present endogenously. Intravenous administration may alter maternal plasma concentrations, but transfer to milk is likely negligible. M/P ratio is unknown. Consider benefits of breastfeeding and potential risks to infant; monitor infant for any adverse effects such as gastrointestinal disturbances. |
| Teratogenic Risk | Aminosyn II 5% in Dextrose 25% is a combination of amino acids and dextrose used for parenteral nutrition. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted with this combination. Dextrose at high doses may cause fetal hyperinsulinism and hypoglycemia. Use only if clearly needed, weighing potential benefits against unknown fetal risks. First trimester: Theoretical risk of metabolic disturbances; second and third trimesters: Risk of maternal hyperglycemia leading to fetal macrosomia, neonatal hypoglycemia, and other complications if blood glucose not controlled. |
■ FDA Black Box Warning
None
| Serious Effects |
["Inborn errors of amino acid metabolism (e.g., maple syrup urine disease, phenylketonuria)","Severe hyperglycemia or diabetic coma","Severe electrolyte disturbances","Patients with anuria or oliguria due to renal failure","Hypersensitivity to any component"]
| Precautions | ["Risk of hyperglycemia, especially in diabetic or stressed patients; monitor blood glucose","Electrolyte imbalances, particularly hyperkalemia, hypophosphatemia, or hypomagnesemia","Fluid overload in patients with renal or cardiac impairment","Refeeding syndrome in severely malnourished patients","Monitor liver function tests due to potential hepatotoxicity from amino acids"] |
| Food/Dietary | Do not administer with foods or oral feeds; compatible with standard parenteral nutrition additives; avoid concurrent use with medications that cause hyperglycemia unless monitored. |
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| Fetal Monitoring | Monitor maternal fluid balance, electrolytes, serum glucose, and acid-base status frequently during administration. In pregnancy, monitor maternal blood glucose closely to avoid hyperglycemia or hypoglycemia. Monitor fetal growth and well-being via ultrasound and non-stress tests as clinically indicated due to potential for macrosomia or intrauterine growth restriction. |
| Fertility Effects | No studies on fertility effects with this combination. Dextrose and amino acids are essential nutrients; no anticipated adverse effects on fertility at therapeutic doses. However, underlying conditions requiring parenteral nutrition may impact fertility. |
| Clinical Pearls | Aminosyn II 5% in Dextrose 25% is a high-calorie parenteral nutrition solution; monitor serum glucose closely due to high dextrose load; requires central line administration due to osmolarity >900 mOsm/L; assess for refeeding syndrome in malnourished patients; check electrolytes including phosphate, magnesium, and potassium before initiation. |
| Patient Advice | This solution is given through a central vein to provide nutrition when you cannot eat. · Report any signs of infection at the IV site, such as redness, swelling, or pain. · You may need frequent blood tests to monitor your blood sugar and electrolyte levels. · Tell your doctor if you experience symptoms of high blood sugar, such as increased thirst, urination, or confusion. |