AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER (AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER).
Aminogen II 3.5% M in Dextrose 5% provides essential and non-essential amino acids and dextrose for parenteral nutrition. Amino acids are utilized for protein synthesis and metabolic processes. Dextrose provides a source of calories and energy.
| Metabolism | Amino acids are primarily metabolized in the liver via transamination and deamination. Dextrose is metabolized via glycolysis and the Krebs cycle, primarily in the liver and peripheral tissues. |
| Excretion | Amino acids are primarily metabolized, with nitrogen excreted as urea (renal, ~80-90%) and ammonia; minimal fecal excretion. Dextrose is fully metabolized to CO2 and water. |
| Half-life | Amino acids have variable elimination half-lives (e.g., 0.5-6 h) depending on individual amino acid; dextrose half-life ~1-2 h. Clinical context: Used for continuous infusion, not bolus. |
| Protein binding | Amino acids: minimal binding (<10%) to plasma proteins; dextrose: not protein bound. |
| Volume of Distribution | Amino acids: Vd ~0.2-0.4 L/kg (total body water); dextrose: Vd ~0.2 L/kg (extracellular fluid). Clinical meaning: distributes throughout body water. |
| Bioavailability | IV: 100% bioavailable. Not administered by other routes. |
| Onset of Action | Immediate upon IV administration; plasma amino acid levels rise within minutes. |
| Duration of Action | Duration depends on infusion rate; after infusion stops, effects persist for several hours due to metabolic processing. Clinical note: Continuous infusion recommended. |
Aminosin II 3.5% M in Dextrose 5% is administered intravenously. Typical adult dose is 1-2 L per day, providing 35-70 g amino acids and 50-100 g dextrose per day, infused at a rate of 0.5-1.5 mL/kg/hour.
| Dosage form | INJECTABLE |
| Renal impairment | In moderate to severe renal impairment (eGFR < 30 mL/min/1.73 m²), reduce dose by 50% or avoid use due to risk of electrolyte imbalances and volume overload. eGFR 30-60 mL/min/1.73 m²: monitor electrolytes and adjust fluid rate; no specific dose reduction required. |
| Liver impairment | Child-Pugh Class B: reduce dose by 25% and monitor for hyperammonemia. Child-Pugh Class C: avoid use due to risk of worsening hepatic encephalopathy; alternative with lower amino acid content preferred. |
| Pediatric use | Dose based on weight: 0.5-2 g amino acid/kg/day (equivalent to 14-57 mL/kg/day of Aminosin II 3.5% M in D5W). Infusion rate should not exceed 0.1 g amino acid/kg/hour. Adjust for fluid and electrolyte needs. |
| Geriatric use | Start at lower end of adult dose (0.5-1 L/day) and titrate based on renal function, fluid status, and electrolyte levels. Monitor for fluid overload and hyperglycemia due to dextrose content. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER (AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER).
| Breastfeeding | Excretion of amino acids and dextrose into breast milk is not clinically significant. Aminosyn II 3.5% M in Dextrose 5% is considered compatible with breastfeeding due to low systemic concentrations and normal constituents of breast milk. M/P ratio is not applicable as components are endogenous substances. No adverse effects on nursing infant reported. |
| Teratogenic Risk | Aminosyn II 3.5% M in Dextrose 5% is a combination of amino acids and dextrose used for parenteral nutrition. Dextrose is not teratogenic at therapeutic doses. Amino acid solutions are generally considered safe in pregnancy when used for nutritional support. No specific teratogenic effects have been reported in humans. However, as with all parenteral nutrition, use during pregnancy should be guided by maternal nutritional needs. There are no well-controlled studies in pregnant women; risks to fetus cannot be ruled out, but benefits may outweigh risks. |
■ FDA Black Box Warning
Not for use in patients with inborn errors of amino acid metabolism, severe liver disease, or severe renal impairment. Must be used under close medical supervision. Can cause hyperglycemia, electrolyte imbalances, and metabolic acidosis.
| Serious Effects |
["Inborn errors of amino acid metabolism","Severe liver disease","Severe renal impairment","Hyperglycemia or metabolic acidosis","Hypersensitivity to any component"]
| Precautions | Monitor serum glucose, electrolytes, and liver function. Use with caution in patients with renal/hepatic impairment, diabetes mellitus, or fluid/electrolyte imbalances. Do not administer simultaneously with blood products through same infusion line. |
| Food/Dietary | No oral food intake is intended as this is parenteral nutrition. However, if transitioning to enteral feeding, avoid high-protein or high-glucose supplements without medical supervision. Monitor for electrolyte imbalances if patient also receives concurrent enteral potassium or phosphate. |
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| Fetal Monitoring | Monitor maternal serum electrolytes, blood glucose, renal and hepatic function, and fluid balance. In pregnancy, monitor fetal growth and well-being via ultrasound if prolonged use. Observe for signs of infection at IV site. For maternal hyperglycemia or metabolic disturbances, adjust infusion rate. |
| Fertility Effects | No known adverse effects on fertility with this formulation. Nutritional support may improve fertility in malnourished women. No specific studies available. |
| Clinical Pearls | Aminosyn II 3.5% M in Dextrose 5% is a peripheral parenteral nutrition (PPN) solution providing amino acids and carbohydrates. Use with caution in patients with renal impairment due to risk of hyperkalemia from acetate. Monitor for signs of fluid overload, especially in elderly or cardiac patients. Avoid peripheral administration of solutions with osmolality >900 mOsm/L to prevent thrombophlebitis; this formulation is typically within safe limits. Check serum electrolytes, glucose, and renal function daily. Do not add medications to bag unless confirmed compatible. |
| Patient Advice | Inform your healthcare provider of any allergies, especially to amino acids or dextrose. · Report any signs of infection at the IV site, such as redness, swelling, or pain. · Tell your doctor if you experience shortness of breath, swelling in your legs, or rapid weight gain (fluid overload). · This medication is a specific nutritional supplement; do not consume additional protein or sugar supplements without consulting your provider. · If you have diabetes, monitor blood glucose closely as this contains dextrose. · Store the IV bag at room temperature, away from light, and do not freeze. Discard if the solution is cloudy or contains particles. |