AMINOSYN II 7%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN II 7% (AMINOSYN II 7%).
Aminosyn II 7% is a crystalline amino acid solution that provides essential and non-essential amino acids for protein synthesis, tissue repair, and maintenance of nitrogen balance. It acts as a substrate for protein synthesis and supports metabolic functions in patients unable to tolerate oral or enteral nutrition.
| Metabolism | Amino acids are metabolized primarily in the liver and peripheral tissues via deamination, transamination, and oxidation. Nitrogen from amino acids is converted to urea in the liver (urea cycle) and excreted by the kidneys. Carbon skeletons are used for gluconeogenesis or energy production. |
| Excretion | Renal as amino acids and metabolites; negligible biliary/fecal. |
| Half-life | Not applicable; exogenous amino acids are rapidly cleared from plasma with a terminal half-life of 15-20 minutes for individual amino acids. |
| Protein binding | Minimal; <10% bound to plasma proteins (mainly albumin). |
| Volume of Distribution | 0.4-0.6 L/kg (approximates total body water, reflecting distribution into extracellular and intracellular spaces). |
| Bioavailability | Intravenous: 100% (only route of administration). |
| Onset of Action | Intravenous: immediate upon infusion; within minutes for nitrogen balance effects. |
| Duration of Action | Intravenous: 2-4 hours post-infusion; sustained effects depend on continuous infusion. |
Intravenous infusion; typical adult dose: 0.8-1.5 g amino acids/kg/day (11.4-21.4 mL/kg/day of 7% solution); rate not exceeding 0.1 g amino acids/kg/hour.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in severe renal impairment (eGFR < 25 mL/min/1.73 m²) unless on dialysis; for moderate impairment (eGFR 25-50), reduce to 0.5-0.8 g/kg/day; monitor BUN and electrolytes. |
| Liver impairment | Contraindicated in Child-Pugh class C; for class A/B, use with caution, reduce dose to 0.5-0.8 g/kg/day, monitor ammonia levels. |
| Pediatric use | Neonates and infants: 2-3 g amino acids/kg/day IV; children: 1.5-2.5 g/kg/day IV; rate adjusted based on metabolic tolerance. |
| Geriatric use | Start at lower end of adult dosing (0.8 g/kg/day), consider renal function, monitor fluid status due to risk of volume overload. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN II 7% (AMINOSYN II 7%).
| Breastfeeding | The excretion of amino acids into human milk is not well studied. Aminosyn II 7% components are endogenous and would be expected to transfer into breast milk minimally. The M/P ratio is not established. Use with caution in breastfeeding women, considering the benefits of adequate maternal nutrition and the lack of known adverse effects in infants. |
| Teratogenic Risk | Aminosyn II 7% is an amino acid solution used for parenteral nutrition. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. The potential for teratogenicity is considered low as amino acids are endogenous substances; however, risks may arise from underlying maternal malnutrition or metabolic disturbances. Use during pregnancy only if clearly needed, weighing benefits against potential fetal risks, which are likely minimal when maternal nutrition is optimized. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to any component","Untreated anuria","Severe metabolic acidosis","Inborn errors of amino acid metabolism","Hepatic coma or severe hepatic insufficiency","Severe renal failure without dialysis support"]
| Precautions | ["Metabolic acidosis","Hyperammonemia","Hepatic or renal impairment may require dose adjustment","Risk of fluid or electrolyte imbalances","Monitor serum electrolytes, blood urea nitrogen, and acid-base balance","Patients with severe hepatic or renal disease may require specialized formulations"] |
| Food/Dietary | No direct food interactions anticipated as this is an intravenous amino acid solution. However, concurrent oral protein intake should be considered in overall nitrogen balance. Avoid grapefruit juice as it may affect metabolism of some co-administered medications. |
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| Fetal Monitoring | Monitor maternal serum electrolytes, blood urea nitrogen, ammonia, glucose, and acid-base balance regularly. Assess fluid status and urine output. In pregnancy, monitor fetal growth and well-being via ultrasound and non-stress tests as clinically indicated. Watch for signs of metabolic complications in the mother, such as hyperammonemia or hyperglycemia. |
| Fertility Effects | No specific data on effects of Aminosyn II 7% on fertility. Since it provides essential amino acids for protein synthesis, it may improve reproductive function in malnourished women. However, no adverse effects on fertility are expected from therapeutic use. |
| Clinical Pearls | Use with caution in patients with renal impairment due to risk of azotemia. Monitor serum electrolytes, BUN, and ammonia levels. Do not administer simultaneously with blood products via same infusion line. Correct electrolyte imbalances before infusion. Adjust rate based on metabolic tolerance and clinical response. |
| Patient Advice | This solution provides protein to help maintain or rebuild body tissues when you cannot eat normally. · Report any signs of allergic reaction such as rash, itching, or difficulty breathing immediately. · You may need regular blood tests to monitor your kidney function and electrolyte levels. · Inform your healthcare provider if you have liver or kidney disease before starting treatment. · Do not stop the infusion abruptly without consulting your doctor. |