AMINOSYN II 3.5% M IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN II 3.5% M IN PLASTIC CONTAINER (AMINOSYN II 3.5% M IN PLASTIC CONTAINER).
Aminosyn II 3.5% M is a crystalline amino acid solution that provides essential and non-essential amino acids for protein synthesis and nitrogen balance maintenance in patients unable to tolerate oral/enteral nutrition. The 'M' formulation includes electrolytes and trace elements. Amino acids are incorporated into endogenous proteins, serving as substrates for gluconeogenesis, oxidative metabolism, and neurotransmitter synthesis.
| Metabolism | Amino acids are metabolized via transamination, deamination, and the urea cycle in the liver. Branched-chain amino acids are metabolized primarily in skeletal muscle. Unused amino acids undergo oxidative metabolism to carbon dioxide, water, and urea. |
| Excretion | 100% renal; amino acids are deaminated and metabolized to urea, which is excreted renally; minimal (<1%) biliary/fecal excretion. |
| Half-life | Variable; amino acids have short plasma half-lives (minutes to hours) due to rapid cellular uptake and metabolism; no meaningful terminal half-life for the mixture. |
| Protein binding | Minimal (<10%) for most amino acids; some, like tryptophan, may bind to albumin; overall negligible binding. |
| Volume of Distribution | 0.15–0.25 L/kg for individual amino acids; reflects distribution into extracellular fluid and cells. |
| Bioavailability | Not applicable (100% IV); no oral bioavailability due to first-pass metabolism. |
| Onset of Action | Immediate (within minutes) upon IV infusion; amino acids are rapidly distributed and incorporated into metabolic pathways. |
| Duration of Action | Duration depends on infusion rate and metabolic demand; continuous infusion required to maintain plasma levels; effects persist for hours after cessation as amino acids are cleared. |
Intravenous administration; typical adult dose is 1 to 2 g amino acids/kg/day, corresponding to 30 to 60 mL/kg/day of 3.5% solution; infusion rate not to exceed 0.1 g amino acids/kg/hour.
| Dosage form | INJECTABLE |
| Renal impairment | No specific GFR-based dose modifications; use with caution in renal impairment, monitoring fluid and electrolyte balance; may require restriction in renal failure to avoid volume overload. |
| Liver impairment | Contraindicated in severe hepatic failure or hepatic encephalopathy due to risk of exacerbation; in mild to moderate impairment (Child-Pugh A or B), use cautiously with reduced dose (e.g., 0.5-1 g/kg/day) and monitor ammonia levels. |
| Pediatric use | For infants and children up to 2 years: 2-3 g/kg/day; for older children: 1-2 g/kg/day; administration via intravenous route; adjust based on age and clinical condition. |
| Geriatric use | Use with caution due to potential for fluid overload, electrolyte imbalances, and renal impairment; dose should be initiated at lower end (1 g/kg/day) and adjusted based on renal function and volume status. |
| 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 PLASTIC CONTAINER (AMINOSYN II 3.5% M IN PLASTIC CONTAINER).
| Breastfeeding | Aminosyn II 3.5% M is a component of parenteral nutrition; its components are normal constituents of breast milk. Excretion into breast milk is expected, but no specific M/P ratio available. Considered compatible with breastfeeding when used as part of total parenteral nutrition, but monitor infant for metabolic disturbances if prolonged high doses used. |
| Teratogenic Risk | Aminosyn II 3.5% M is a parenteral nutrition solution containing crystalline amino acids. No teratogenic effects have been reported in animal studies at clinically relevant doses. In pregnancy, use when clearly needed. First trimester: likely safe as amino acids are physiological. Second and third trimesters: no known fetal risks. However, ensure electrolyte and metabolic balance to avoid maternal acidosis or electrolyte abnormalities that could affect fetus. |
■ FDA Black Box Warning
None. Aminosyn II products are not associated with FDA boxed warnings.
| Serious Effects |
["Severe hepatic disease with hepatic encephalopathy","Inborn errors of amino acid metabolism (e.g., maple syrup urine disease, phenylketonuria)","Hypersensitivity to any component","Severe azotemia or renal failure without appropriate alternatives"]
| Precautions | ["Risk of hyperglycemia; monitor blood glucose and adjust insulin if needed","Monitor fluid and electrolyte status, especially in renal or cardiac impairment","Hepatic impairment may require dose adjustment or alternative formulations","Risk of central line-associated bloodstream infection with intravenous administration","Monitor for signs of metabolic alkalosis or acidosis"] |
| Food/Dietary | No known food interactions. This product is for intravenous use only and is not administered orally. |
Loading safety data…
| Fetal Monitoring | Monitor maternal serum electrolytes, blood glucose, acid-base balance, liver and renal function. Monitor fetal growth and well-being via ultrasound if long-term use. Assess for signs of maternal infection or metabolic complications that could affect placental function. |
| Fertility Effects | No specific studies on fertility. Restoration of nutritional status with amino acid supplementation may improve fertility in malnourished individuals. No direct adverse effects on fertility expected at therapeutic doses. |
| Clinical Pearls | Aminosyn II 3.5% M is a parenteral nutrition solution for peripheral vein administration. Monitor serum electrolytes, including potassium, magnesium, and phosphate, as well as acid-base status, to avoid metabolic complications. Use with caution in patients with renal impairment to prevent nitrogen overload. Verify line compatibility with other IV additives. |
| Patient Advice | This solution is given through a vein and provides protein and electrolytes when you cannot eat normally. · Report any signs of infection at the IV site, such as redness, swelling, or pain, or symptoms like fever or chills. · You may need regular blood tests to monitor your electrolyte levels and kidney function. · Do not mix other medications into this solution unless directed by your healthcare provider. |