AMINOSYN II 10%
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN II 10% (AMINOSYN II 10%).
Amino acids provide substrates for protein synthesis and nitrogen balance maintenance in patients unable to tolerate adequate oral/enteral intake.
| Metabolism | Amino acids undergo hepatic and peripheral tissue metabolism via transamination, deamination, and incorporation into proteins; waste nitrogen is converted to urea in the liver via the urea cycle. |
| Excretion | Primarily renal as amino acids and metabolites; >90% of infused amino acids are reabsorbed by proximal tubules, with less than 10% excreted unchanged in urine. Biliary/fecal excretion negligible. |
| Half-life | Variable depending on metabolic state; for individual amino acids, half-lives range from 10 to 100 minutes. In renal impairment, accumulation can occur. No single terminal half-life for the mixture. |
| Protein binding | Amino acids are minimally protein-bound (<5%); primarily free in plasma. Specific binding proteins include albumin for tryptophan. |
| Volume of Distribution | Approximately 0.2-0.4 L/kg for total amino acids; reflects distribution into total body water and lean body mass. Vd is lower in dehydration. |
| Bioavailability | Intravenous: 100% (bioavailable). Not administered orally for systemic effects; oral bioavailability irrelevant. |
| Onset of Action | Intravenous infusion: Metabolic effects (nitrogen balance, protein synthesis) begin within 1-2 hours of start of infusion. |
| Duration of Action | Effects on nitrogen balance persist for 12-24 hours post-infusion; clinical duration is infusion-dependent, typically 24-hour continuous infusion for TPN. |
Intravenous infusion: 500 mL to 1 L of 10% solution (50-100 g amino acids) per day, administered at a rate not exceeding 100 mL/h. Typical initial dose: 0.8-1.5 g/kg/day of amino acids, adjusted based on metabolic needs and tolerance.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR 30-59 mL/min: reduce dose by 50%. For GFR 15-29 mL/min: reduce dose by 75%. For GFR <15 mL/min or dialysis: avoid unless patient is on renal replacement therapy; dose not to exceed 0.5 g/kg/day. Monitor serum urea and electrolytes closely. |
| Liver impairment | Contraindicated in severe hepatic insufficiency (Child-Pugh class C) due to risk of hyperammonemia. For Child-Pugh class A or B: initiate at 0.5 g/kg/day and titrate up to 1 g/kg/day as tolerated, with monitoring of ammonia levels. |
| Pediatric use | Newborns and children: 2-3 g/kg/day of amino acids as a continuous IV infusion, adjusted in neonates based on gestational age and weight. Typical starting dose: 1 g/kg/day, increase by 0.5 g/kg/day to target, not to exceed 3.5 g/kg/day in term infants. Rate: 0.5-1.5 g/kg/h. |
| Geriatric use | No specific dose adjustment, but use lower initial doses (0.5-1 g/kg/day) due to decreased renal function and increased risk of fluid overload. Monitor serum electrolytes and fluid status closely. Maximum infusion rate: 100 mL/h. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN II 10% (AMINOSYN II 10%).
| Breastfeeding | Amino acids are normally present in breast milk. Exogenous amino acids from infusion are expected to enter milk minimally. M/P ratio not established. Compatible with breastfeeding if maternal nutrition is inadequate, but monitor infant for metabolic disturbances. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies; however, adequate human studies are lacking. Use in pregnancy only if clearly needed, with careful monitoring of amino acid levels. No known trimester-specific risks. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to any component","Severe hepatic disease with encephalopathy","Severe renal failure without dialysis","Hyperammonemia","Inborn errors of amino acid metabolism (e.g., phenylketonuria)"]
| Precautions | ["Monitor for metabolic acidosis, hyperammonemia, and signs of fluid overload","Risk of hepatorenal syndrome in patients with hepatic or renal impairment","Monitor serum electrolytes, liver function, and renal function","Use with caution in patients with inborn errors of amino acid metabolism"] |
| Food/Dietary | No direct food interactions as this is an intravenous product. However, when transitioning to oral nutrition, coordinate with dietitian to avoid protein overload. Patients on parenteral nutrition should not consume oral foods unless prescribed, as oral intake may alter metabolic balance. |
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| Fetal Monitoring |
| Monitor maternal serum electrolytes, acid-base balance, BUN, ammonia, and liver function tests. Monitor fetal growth and well-being via ultrasound if used long-term. Observe for signs of fluid overload or metabolic acidosis. |
| Fertility Effects | No known adverse effects on fertility. May improve fertility in malnourished women by restoring nutritional status. |
| Clinical Pearls | Aminosyn II 10% is a crystalline amino acid solution used for parenteral nutrition. It contains essential and nonessential amino acids without electrolytes. Monitor serum ammonia levels in patients with hepatic impairment as it may precipitate encephalopathy. Use with caution in renal insufficiency due to risk of azotemia. Do not administer simultaneously with blood products through same infusion line due to risk of incompatibility. Ensure adequate caloric co-administration (dextrose/lipids) to prevent amino acids being used for gluconeogenesis. Check for yellow discoloration of solution; do not use if turbid or contains precipitate. |
| Patient Advice | This medication is a protein solution given intravenously to provide nutrition when you cannot eat by mouth. · Tell your healthcare provider if you have liver or kidney disease, as dose adjustments may be needed. · Regular blood tests will be required to monitor your kidney and liver function and electrolyte levels. · Report any signs of infection at the IV site (redness, swelling, pain) or systemic symptoms like fever or chills. · Do not stop the infusion or adjust the rate without your doctor's approval. |