AMINOSYN II 3.5%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN II 3.5% (AMINOSYN II 3.5%).
Amino acids serve as substrates for protein synthesis, providing essential and non-essential nitrogen sources for anabolism in patients unable to tolerate oral or enteral nutrition.
| Metabolism | Amino acids undergo hepatic metabolism for protein synthesis, transamination, deamination, and oxidation; nitrogen is converted to urea via the urea cycle. |
| Excretion | Renal: 95% of infused amino acids are reabsorbed; excess amino acids are deaminated and urea is excreted renally. Fecal/Biliary: negligible (<1%). |
| Half-life | Terminal elimination half-life of individual amino acids ranges from 10 to 30 minutes for most, with glutamine and arginine slightly longer (30–45 min). No defined half-life for the mixture; clinically, steady-state achieved in 2–3 hours with continuous infusion. |
| Protein binding | Amino acids are minimally protein-bound (<5%); primarily free in plasma. Binding proteins: albumin (negligible). |
| Volume of Distribution | Vd approximates total body water (0.5–0.6 L/kg) for most amino acids. Clinically indicates distribution into lean tissues. |
| Bioavailability | Intravenous: 100% (complete bioavailability). Not administered via other routes due to hypertonicity; oral and enteral not applicable. |
| Onset of Action | Intravenous: metabolic effects (e.g., plasma amino acid elevation) occur within 15–30 minutes of starting infusion. |
| Duration of Action | Intravenous: metabolic effects persist 2–4 hours post-infusion; nitrogen balance improvement requires sustained therapy. Duration is dependent on infusion rate and individual clearance. |
Intravenous infusion of 250-500 mL/day (8.75-17.5 g amino acids) as a component of parenteral nutrition; rate up to 125 mL/hour; titrate based on metabolic response.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in severe renal impairment (GFR <30 mL/min/1.73 m²) unless on renal replacement therapy. For moderate impairment (GFR 30-59 mL/min/1.73 m²), reduce dose to 50% of standard and monitor blood urea nitrogen (BUN) and electrolytes. |
| Liver impairment | Contraindicated in Child-Pugh class C cirrhosis. In class A or B, reduce dose to 50-75% of standard; monitor ammonia levels; avoid in hepatic encephalopathy. |
| Pediatric use | For infants and children, initial dose: 1-1.5 g amino acids/kg/day (equating to 28.6-42.9 mL/kg/day of 3.5% solution) by continuous infusion; titrate to 2-3 g/kg/day based on growth and metabolic parameters. Maximum infusion rate: 2 mL/kg/hour. |
| Geriatric use | No specific adjustment in elderly. Use with caution due to age-related renal and hepatic decline; monitor fluid and electrolyte status; start at lower end of adult dose range (250 mL/day) and titrate slowly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN II 3.5% (AMINOSYN II 3.5%).
| Breastfeeding | Excretion into breast milk unknown. Consider benefits of breastfeeding vs. potential risks. No M/P ratio available. Caution advised. |
| Teratogenic Risk | Aminogen II 3.5% is an amino acid solution used for parenteral nutrition. No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. General risks of parenteral nutrition during pregnancy include potential for metabolic disturbances, but specific teratogenic effects are not defined. Use only if clearly needed. |
■ FDA Black Box Warning
Not for use in patients with inborn errors of amino acid metabolism, severe hepatic failure, or severe uremia without dialysis.
| Serious Effects |
["Hypersensitivity to any component","Inborn errors of amino acid metabolism (e.g., maple syrup urine disease)","Severe hepatic failure or hepatic coma","Severe azotemia or uremia not managed by dialysis"]
| Precautions | ["Risk of hyperammonemia, especially in infants and patients with hepatic insufficiency","Risk of metabolic acidosis, electrolyte imbalances, and fluid overload","Monitor serum electrolytes, blood glucose, liver function, and acid-base balance regularly","Use caution in renal impairment, as accumulation of amino acids and nitrogenous wastes may occur"] |
| Food/Dietary | No specific food interactions. Parenteral nutrition bypasses the gastrointestinal tract; however, concurrent oral or enteral intake should be monitored to avoid overfeeding. In patients transitioning to oral diet, gradual introduction is recommended. |
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| Fetal Monitoring |
| Monitor serum electrolytes, blood glucose, acid-base balance, renal function, hepatic function, and nitrogen balance. Monitor fetal growth and well-being by ultrasound if prolonged use. |
| Fertility Effects | No data on fertility effects. Adequate nutrition is essential for reproductive function; correction of malnutrition may improve fertility. |
| Clinical Pearls | AMINOSYN II 3.5% is a balanced amino acid solution used for parenteral nutrition. Monitor serum electrolytes, BUN, and ammonia levels regularly. Avoid rapid infusion to prevent hyperammonemia. Use with caution in renal or hepatic impairment; adjust nitrogen content accordingly. Ensure adequate non-protein calories to promote protein synthesis and avoid gluconeogenesis. |
| Patient Advice | This medication provides essential nutrients when you cannot eat by mouth. · Report any signs of infection at the IV site, such as redness, swelling, or pain. · Notify your healthcare provider if you experience nausea, vomiting, headache, or confusion. · Regular blood tests will be needed to monitor your response to therapy. |