AMINOSYN 8.5% (PH6)
Clinical safety rating: caution
Comprehensive clinical and safety monograph for AMINOSYN 8.5% (PH6) (AMINOSYN 8.5% (PH6)).
Aminosyn 8.5% (pH 6) provides a mixture of essential and nonessential amino acids for protein synthesis and nitrogen balance maintenance in patients unable to tolerate oral or enteral nutrition.
| Metabolism | Amino acids are metabolized via deamination, transamination, and decarboxylation pathways in the liver and other tissues. |
| Excretion | Primarily renal; elimination depends on metabolic utilization. Unused amino acids are deaminated and excreted as urea in urine (over 90%). Fecal elimination is negligible. |
| Half-life | Not applicable as a fixed value; elimination half-life of individual amino acids varies (minutes to hours) and is dependent on metabolic demand and renal function. |
| Protein binding | Minimal to moderate; individual amino acids bind variably to albumin and other plasma proteins (range 5-50%). |
| Volume of Distribution | Widely distributed to total body water; approximate Vd of individual amino acids is 0.5-1.0 L/kg, reflecting distribution into extracellular and intracellular spaces. |
| Bioavailability | 100% by intravenous route; not administered orally due to hepatic first-pass metabolism and poor bioavailability. |
| Onset of Action | Intravenous infusion: Plasma amino acid levels rise within minutes; clinical effects (e.g., improved nitrogen balance) occur over hours to days. |
| Duration of Action | Duration is proportional to infusion rate and metabolic utilization; effects on nitrogen balance persist for hours after infusion, but no fixed duration as it is a nutritional supplement. |
1-1.5 g amino acids/kg/day intravenously, typically 500 mL of a 8.5% solution (42.5 g amino acids) infused over 8-24 hours.
| Dosage form | INJECTABLE |
| Renal impairment | In acute kidney injury or GFR <30 mL/min/1.73m², reduce dose to 0.5-0.8 g/kg/day and monitor serum urea and electrolytes. For dialysis patients, may increase to 1.0-1.5 g/kg/day post-dialysis. |
| Liver impairment | Child-Pugh A: no adjustment. Child-Pugh B: reduce dose to 0.8-1.0 g/kg/day. Child-Pugh C: use 0.5-0.8 g/kg/day with branched-chain amino acid (BCAA)-enriched formulations if encephalopathy present. |
| Pediatric use | Infants: 2-3 g/kg/day IV; Children: 1.5-2 g/kg/day IV. Adjust based on weight, age, and clinical status. Typically infused over 12-24 hours. |
| Geriatric use | Start at lower end of adult dosing (0.8-1.0 g/kg/day IV) due to age-related renal function decline; monitor fluid and electrolyte balance closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN 8.5% (PH6) (AMINOSYN 8.5% (PH6)).
| Breastfeeding | Excreted in breast milk; M/P ratio not established. Considered compatible with breastfeeding when used as part of parenteral nutrition. |
| Teratogenic Risk | No evidence of teratogenicity; amino acids are endogenous nutrients. Fetal risks are minimal when used as indicated in pregnancy for maternal nutritional support. |
| Fetal Monitoring | Monitor for fluid, electrolyte, and acid-base imbalances; assess hepatic, renal, and metabolic status; fetal growth and well-being via ultrasound in prolonged use. |
■ FDA Black Box Warning
Not for use in patients with severe liver disease, severe uremia, or inborn errors of amino acid metabolism.
| Serious Effects |
["Severe liver disease","Severe uremia","Inborn errors of amino acid metabolism","Hypersensitivity to any component"]
| Precautions | ["Monitor fluid and electrolyte balance","Risk of hyperammonemia in hepatic impairment","Monitor for metabolic acidosis","Use with caution in renal insufficiency"] |
| Food/Dietary | Aminosyn 8.5% (pH 6) is administered intravenously, so there are no direct food interactions. However, the patient's overall nutritional status should be assessed, and oral intake of protein, electrolytes, and fluids should be coordinated with the parenteral nutrition to avoid imbalances. |
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| Fertility Effects | No known adverse effects on fertility; correction of malnutrition may improve fertility. |
| Clinical Pearls | Aminosyn 8.5% (pH 6) is a crystalline amino acid solution used for parenteral nutrition. It contains essential and nonessential amino acids without electrolytes. Use with caution in patients with hepatic or renal impairment. Monitor serum ammonia levels, as hyperammonemia can occur. Discard if solution is not clear or if seal is broken. Administer via central line only; peripheral administration may cause thrombophlebitis. |
| Patient Advice | This medication is a sterile amino acid solution used as part of your intravenous nutrition. · Do not use if the solution is cloudy or contains particles. · Notify your healthcare provider immediately if you experience nausea, vomiting, confusion, or difficulty breathing. · You may need regular blood tests to monitor your kidney and liver function. · Report any signs of infection at the IV site, such as redness, swelling, or pain. |