AMINOSYN 7% (PH6)
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN 7% (PH6) (AMINOSYN 7% (PH6)).
Amino acids serve as substrates for protein synthesis and metabolic processes, providing essential and non-essential amino acids for tissue repair and maintenance.
| Metabolism | Amino acids are metabolized via deamination, transamination, and urea cycle; primarily in the liver. |
| Excretion | Amino acids in Aminosyn 7% (pH6) are primarily metabolized; excess nitrogen is excreted renally as urea. Approximately 80-90% of infused amino acids are utilized for protein synthesis or metabolized; remaining nitrogen is eliminated as urea via kidneys. Biliary and fecal elimination are negligible. |
| Half-life | The elimination half-life of individual amino acids varies, typically 0.5-2 hours for most, reflecting rapid incorporation into metabolic pools. For total amino acid mixture, functional half-life is approximately 1-2 hours in patients with normal hepatic and renal function. |
| Protein binding | Amino acids are minimally bound to plasma proteins (<10%). Most are free in plasma; notable exceptions include tryptophan which is ~70% bound to albumin, while others like branched-chain amino acids are <10% bound. |
| Volume of Distribution | Total amino acids distribute into total body water, approximately 0.5-0.7 L/kg, reflecting distribution into extracellular and intracellular spaces. Vd is higher for individual amino acids that are actively transported into cells (e.g., glutamine: 1.2 L/kg). |
| Bioavailability | Only intravenous administration is clinically relevant; bioavailability is 100% by IV route. Not administered orally or intramuscularly; no oral bioavailability data. |
| Onset of Action | Intravenous infusion: Uptake into tissues begins immediately; net nitrogen retention and protein synthesis effects are detectable within 1-2 hours of infusion start. |
| Duration of Action | Duration depends on infusion rate and metabolic demand. After cessation of infusion, plasma amino acid levels return to baseline within 2-4 hours. Clinical effects on nitrogen balance persist for the duration of infusion and for several hours post-infusion. |
AminoSyn 7% (pH 6) is administered intravenously as a component of parenteral nutrition. The typical adult dose is 1.0-1.5 g amino acids/kg/day, infused at a rate not exceeding 0.1 g amino acids/kg/hour. The infusion rate and volume are determined by the patient's metabolic needs, clinical status, and concurrent dextrose and lipid administration.
| Dosage form | INJECTABLE |
| Renal impairment | In patients with impaired renal function (GFR <50 mL/min), avoid or reduce amino acid dose to 0.5-0.8 g/kg/day to prevent azotemia. Monitor serum BUN and creatinine. For patients on dialysis, doses may be adjusted upward (1.0-1.2 g/kg/day) to compensate for losses, but careful monitoring is required. |
| Liver impairment | In patients with hepatic impairment (Child-Pugh class B or C), initiate at lower doses (0.5-0.8 g amino acids/kg/day) and titrate based on tolerance. Avoid in severe hepatic encephalopathy. Use specialized amino acid formulations (e.g., HepatAmin) if available; standard AminoSyn may worsen encephalopathy due to high aromatic amino acid content. |
| Pediatric use | For pediatric patients, dosing is weight-based: neonates and infants: 2.0-3.0 g amino acids/kg/day; children: 1.5-2.5 g/kg/day. Infusion rate should not exceed 0.1-0.15 g amino acids/kg/hour. Adjust based on growth, nitrogen balance, and metabolic stability. |
| Geriatric use |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN 7% (PH6) (AMINOSYN 7% (PH6)).
| Breastfeeding | No data available on excretion of amino acids from this formulation into breast milk. Given its composition of essential and non-essential amino acids normally present in maternal plasma, systemic levels are likely equilibrated with breast milk concentrations. However, specific M/P ratio is unknown. Intravenous infusion is typically used in hospitalized or critically ill patients; breastfeeding may not be feasible. Benefit of maternal nutrition must be weighed against potential risks. |
| Teratogenic Risk | Aminosyn 7% (pH6) is a crystalline amino acid solution used for parenteral nutrition. No teratogenic effects have been reported in human pregnancies; however, animal reproduction studies have not been conducted. Use during pregnancy should be limited to cases where clear need and benefit outweigh potential risks. First trimester: insufficient data; second/third trimesters: use only if clearly indicated. Parenteral nutrition itself may contribute to metabolic disturbances affecting fetal development if not properly managed. |
■ FDA Black Box Warning
Not for use in patients with inborn errors of amino acid metabolism, severe liver disease, or patients on high-risk medications that may interact (e.g., MAOIs).
| Serious Effects |
["Hypersensitivity to any component","Inborn errors of amino acid metabolism (e.g., maple syrup urine disease, phenylketonuria)","Severe hepatic failure","Severe metabolic acidosis"]
| Precautions | ["Monitor for hyperammonemia, metabolic acidosis, and electrolyte imbalances","Use caution in patients with renal or hepatic impairment","Risk of infection due to intravenous administration"] |
| Food/Dietary | No direct food interactions as Aminosyn is administered intravenously. However, concurrent oral intake must be coordinated to avoid overfeeding. Enteral nutrition should be considered if gastrointestinal function is intact. |
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| In geriatric patients, initiate at the lower end of the adult dose (1.0 g amino acids/kg/day) due to potential age-related decline in renal and hepatic function. Monitor fluid and electrolyte status closely, as these patients may have reduced cardiovascular reserve and are at increased risk for fluid overload. Adjust dose based on renal function and tolerance. |
| Fetal Monitoring | Monitor maternal electrolytes, acid-base balance, blood urea nitrogen (BUN), ammonia levels, liver function tests (AST, ALT, bilirubin), glucose, and triglycerides. Fetal monitoring: assess fetal growth via serial ultrasound in long-term use; monitor for signs of intrauterine growth restriction (IUGR) if maternal metabolic disturbances occur. Consider non-stress test in third trimester if maternal acidosis or electrolyte imbalances arise. |
| Fertility Effects | No known direct effects on fertility from amino acid solutions. However, severe malnutrition requiring parenteral nutrition can impair fertility; restoration of nutritional status may improve reproductive function. No specific data on aminophylline or other components affecting ovulation or spermatogenesis. Theoretical risk from trace elements or additives if present. |
| Clinical Pearls | Aminosyn 7% (pH6) is a crystalline amino acid solution used for parenteral nutrition. Monitor serum electrolytes, BUN, and ammonia levels due to risk of metabolic acidosis or hyperammonemia. Assess fluid balance and renal function; adjust infusion rate to avoid volume overload. Use with caution in patients with hepatic or renal impairment. Do not administer simultaneously with blood through same infusion line due to risk of incompatibility. |
| Patient Advice | This medication provides essential building blocks for protein synthesis when you cannot eat or drink normally. · Report any signs of allergic reaction: rash, itching, swelling, or difficulty breathing. · Notify your healthcare provider if you experience nausea, vomiting, headache, or confusion. · Do not adjust the infusion rate yourself; only trained personnel should monitor and control administration. · Regular blood tests are required to monitor kidney and liver function, as well as electrolyte levels. |