AMINOSYN 10%
Clinical safety rating
cautionComprehensive clinical and safety monograph for AMINOSYN 10% (AMINOSYN 10%).
Aminosyn 10% provides a mixture of essential and non-essential amino acids to support protein synthesis and maintain nitrogen balance in patients unable to tolerate adequate oral or enteral nutrition. Each amino acid serves as a substrate for protein synthesis, hormone production, and other metabolic processes.
| Metabolism | Amino acids are metabolized primarily in the liver via deamination, transamination, and other pathways. The carbon skeletons enter the citric acid cycle or gluconeogenesis, and nitrogen is converted to urea. |
| Excretion | Renal (primarily as amino acids and metabolites); ~90% of infused amino nitrogen is excreted renally within 24-48 hours; <5% biliary/fecal. |
| Half-life | Amino acids: 0.5-1 hour for free amino acids; terminal half-life of infused nitrogen is approximately 2-4 hours; clinical context: reflects rapid uptake and metabolism. |
| Protein binding | Amino acids: negligible protein binding (<5%); albumin binds some tryptophan and branched-chain amino acids minimally. |
| Volume of Distribution | Amino acids: 0.3-0.5 L/kg (approximates extracellular fluid volume); clinical meaning: distributes primarily in ECF. |
| Bioavailability | Intravenous: 100% (only route of administration); not absorbed orally as parenteral formulation. |
| Onset of Action | Intravenous: immediate (within minutes) as plasma amino acid concentrations rise; clinical effects (nitrogen retention) within 1-2 hours. |
| Duration of Action | Intravenous: 2-4 hours for metabolic effects; duration depends on infusion rate and metabolic demand; continuous infusion may be needed. |
| Molecular Weight | Aminosyn 10% is a mixture; average molecular weight ~140 Da per amino acid residue, but specify as 'not applicable' or provide a representative value: 146 Da (average of essential amino acids). |
Intravenous infusion: 1-1.5 g/kg/day (as amino acids), typically 500 mL of 10% solution (50 g amino acids) over 8-12 hours daily.
| Dosage form | INJECTABLE |
| Renal impairment | GFR <50 mL/min: reduce dose to 0.5-0.8 g/kg/day. GFR <15 mL/min: avoid or use with extreme caution, monitor serum amino acids. |
| Liver impairment | Child-Pugh class B: reduce dose by 50%. Child-Pugh class C: contraindicated due to risk of hepatic encephalopathy. |
| Pediatric use | Neonates: 2-3 g/kg/day IV. Infants/children: 1.5-2.5 g/kg/day IV. Adjust based on metabolic status and growth. |
| Geriatric use | Initiate at low end of adult dose (1 g/kg/day IV), monitor renal function and adjust accordingly; consider reduced metabolic clearance. |
| 1st trimester | Considered safe when used as required for nutritional support; essential amino acids are necessary for fetal development. However, use only if clearly indicated due to limited data. |
| 2nd trimester | Generally safe if indicated; monitor fluid and electrolyte balance. |
| 3rd trimester | Safe if indicated; avoid excessive protein loads in preeclampsia or renal impairment. |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN 10% (AMINOSYN 10%).
| Placental transfer | Amino acids are actively transported across the placenta by specific transporters; fetal levels are typically higher than maternal. No specific data for Aminosyn 10%, but individual amino acids are known to cross. |
| Breastfeeding | Aminosyn 10% is considered compatible with breastfeeding. It is an intravenous amino acid solution; maternal infusion will increase amino acid levels in milk but no adverse effects expected. Monitor infant for feeding tolerance. |
| Lactation Rating | L1 - Compatible |
| Teratogenic Risk | Aminosyn 10% 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 with this formulation. In the first trimester, the risk of teratogenicity is theoretical; essential amino acids are necessary for fetal development, but excesses or imbalances may be harmful. During the second and third trimesters, supplementation may be beneficial for maternal and fetal nutrition, but potential risks include metabolic acidosis or electrolyte disturbances if not properly monitored. |
| Fetal Monitoring | Monitor maternal serum ammonia, BUN, electrolytes, acid-base status, and renal function. Fetal monitoring includes assessment of fetal growth, amniotic fluid volume, and placental function via serial ultrasounds. In preterm labor or when infection risk is high, monitor for metabolic complications. |
| Fertility Effects | No specific data on fertility effects with Aminosyn 10%. Parenteral nutrition in malnourished patients may restore or improve fertility by correcting nutritional deficiencies. No direct adverse effects on reproduction have been reported. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to any componentInborn errors of amino acid metabolismSevere hepatic failure with hyperammonemiaSevere renal failure without dialysisSevere metabolic acidosis
| Precautions | Risk of hyperammonemia, especially in patients with hepatic impairment or inborn errors of urea cycle, Electrolyte imbalances may occur; monitor serum electrolytes frequently, Monitor for signs of infection at infusion site, Use caution in patients with renal impairment, as accumulation of amino acids may occur, May cause metabolic acidosis in certain patients |
| Food/Dietary | No direct food interactions, but ensure adequate non-protein calorie intake (carbohydrates, fats) to prevent amino acid utilization for energy. Avoid concurrent use with high-protein oral diets without medical supervision. For patients with phenylketonuria (PKU), verify product composition as some contain phenylalanine. |
| Clinical Pearls | Use central line administration for concentrations >5% to reduce thrombophlebitis risk. Monitor serum electrolytes, BUN, glucose, and liver function tests frequently. Adjust infusion rate based on metabolic tolerance; start at 100 mL/hr and increase gradually. Contraindicated in severe hepatic disease, uremia, or maple syrup urine disease. Do not use as a sole source of nutrition; provide concurrent calories from carbohydrates and fats. |
| Patient Advice | This solution provides amino acids for protein building when you cannot eat normally. · Report signs of infection at catheter site: redness, swelling, pain, or drainage. · Common side effects include nausea, flushing, and warmth during infusion. · You will need regular blood tests to monitor kidney, liver, and metabolic function. · Inform your doctor if you have diabetes, kidney disease, or a history of gout. |
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