AMINOSYN 3.5% W/ DEXTROSE 25% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN 3.5% W/ DEXTROSE 25% IN PLASTIC CONTAINER (AMINOSYN 3.5% W/ DEXTROSE 25% IN PLASTIC CONTAINER).
Aminosyn 3.5% with dextrose 25% provides amino acids for protein synthesis and dextrose as a carbohydrate calorie source, primarily to prevent protein catabolism and maintain nitrogen balance in patients requiring parenteral nutrition.
| Metabolism | Amino acids are metabolized primarily in the liver via transamination and deamination; dextrose undergoes glycolysis and subsequent oxidative metabolism. |
| Excretion | Renal excretion of amino acids and dextrose metabolites; urea nitrogen accounts for ~80% of nitrogen elimination. Biliary/fecal elimination is negligible for intact components. |
| Half-life | Amino acids: 0.5-2 hours (plasma clearance). Dextrose: 1.5-2 hours (glucose half-life in normoglycemic patients); clinically, infusion must be continuous to maintain steady state. |
| Protein binding | Amino acids: minimal (<10%), bound to albumin and globulins; dextrose: negligible binding. |
| Volume of Distribution | Amino acids: Vd = 0.15-0.3 L/kg (total body water). Dextrose: Vd = 0.2 L/kg (extracellular fluid). Clinical meaning: distributes primarily into lean body mass and extracellular spaces. |
| Bioavailability | Intravenous: 100%. Not administered via oral or other routes due to product formulation. |
| Onset of Action | Intravenous: Immediate (within minutes) for amino acid provision and dextrose infusion; plasma amino acid levels rise within 15-30 minutes. |
| Duration of Action | Duration of metabolic effect: 2-4 hours after cessation of infusion; must be continuously infused for sustained nutritional support. |
Intravenous infusion: 500 mL to 1000 mL per day, typically at a rate not exceeding 3 mL/kg/hour. Adjusted based on metabolic needs and fluid status.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in severe renal impairment (GFR < 30 mL/min) or dialysis due to risk of volume overload and electrolyte abnormalities. For moderate impairment (GFR 30-59 mL/min), reduce dose by 50% and monitor electrolytes. |
| Liver impairment | Child-Pugh Class A: No adjustment. Class B: Reduce dose by 50% and monitor ammonia levels. Class C: Avoid use due to risk of hepatic encephalopathy. |
| Pediatric use | Weight-based: 2-3 g amino acids/kg/day and 10-15 g dextrose/kg/day. Infuse at rate of 0.1-0.2 g dextrose/kg/hour initially, titrate to maintain blood glucose between 80-120 mg/dL. |
| Geriatric use | Reduce initial rate to 1-2 mL/kg/hour, monitor fluid balance closely due to increased risk of hypervolemia and renal impairment. Adjust based on GFR and cardiac 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 25% IN PLASTIC CONTAINER (AMINOSYN 3.5% W/ DEXTROSE 25% IN PLASTIC CONTAINER).
| Breastfeeding | Both dextrose and amino acids are endogenous substances and are excreted into breast milk in small amounts. No M/P ratio available. Considered compatible with breastfeeding; use only if clearly needed and monitor infant for hyperglycemia. |
| Teratogenic Risk | No teratogenic risk data specific to this combination. Both components are essential nutrients; dextrose and amino acids are not teratogenic at standard doses. However, hyperglycemia from dextrose may be associated with congenital anomalies if glucose levels are poorly controlled. No trimester-specific risks identified. |
■ FDA Black Box Warning
Death may occur due to improper administration; must be used under medical supervision. Solutions are hypertonic and may cause severe complications if extravasation occurs.
| Serious Effects |
["Severe hepatic disease with encephalopathy","Severe renal failure without dialysis","Hyperglycemia or diabetic ketoacidosis","Hypersensitivity to any component","Unstable cardiovascular status"]
| Precautions | ["Risk of hyperglycemia, particularly in diabetic or stressed patients","Fluid overload in patients with cardiac or renal impairment","Electrolyte abnormalities requiring monitoring","Infection risk from catheter-related bloodstream infections","Osmotic diuresis with dextrose loads"] |
| Food/Dietary | No direct food interactions, but enteral intake should be coordinated if transitioning to oral feeding. Avoid high-sugar foods if hyperglycemia occurs. |
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| Fetal Monitoring | Monitor maternal blood glucose, serum electrolytes, fluid balance, and renal function during prolonged use. Fetal monitoring as per gestational age; ultrasound for growth if used in pregnancy. |
| Fertility Effects | No known adverse effects on fertility from these components. Underlying conditions requiring total parenteral nutrition may impact fertility. |
| Clinical Pearls | Monitor serum electrolytes, glucose, and renal function daily. Administer via central line due to high dextrose concentration (25%) to prevent thrombophlebitis. Use with caution in patients with renal impairment, heart failure, or hyperglycemia. Avoid rapid infusion to prevent osmotic diuresis. Check for allergies to corn products (dextrose source). |
| Patient Advice | This solution provides nutrition through a vein; report any swelling, pain, or redness at the infusion site. · You may need frequent blood tests to monitor your blood sugar, kidney function, and electrolyte levels. · Tell your healthcare provider if you have diabetes, kidney disease, or heart failure. · Do not stop the infusion abruptly; the rate will be adjusted gradually. |