AMINOSYN 10% (PH6)
Clinical safety rating
cautionComprehensive clinical and safety monograph for AMINOSYN 10% (PH6) (AMINOSYN 10% (PH6)).
Aminosyn 10% is a parenteral amino acid solution that provides essential and non-essential amino acids for protein synthesis, helping to maintain nitrogen balance and support tissue repair and growth in patients unable to receive adequate nutrition enterally.
| Metabolism | Amino acids are metabolized through deamination, transamination, and decarboxylation pathways, primarily in the liver, with nitrogen converted to urea via the urea cycle and carbon skeletons entering the Krebs cycle. |
| Excretion | Amino acids from Aminosyn 10% are primarily utilized for protein synthesis and metabolic processes. Excess nitrogen is eliminated via the kidneys as urea (renal elimination accounts for >90% of nitrogen excretion). Minimal biliary/fecal elimination (<5%) occurs via unabsorbed amino acids in patients with malabsorption. In renal impairment, elimination is reduced. |
| Half-life | The terminal elimination half-life of individual amino acids varies (1–4 hours) depending on metabolic demand and renal function. For the amino acid mixture, the effective half-life is approximately 2 hours in patients with normal renal function. This short half-life necessitates continuous or frequent infusion to maintain stable plasma levels. |
| Protein binding | Amino acids exhibit low protein binding (<10%) to plasma proteins (primarily albumin). High-affinity binding is negligible; most amino acids circulate freely. |
| Volume of Distribution | Volume of distribution (Vd) for amino acids in Aminosyn 10% ranges from 0.3–0.5 L/kg, approximating total body water. This reflects extensive distribution into extracellular and intracellular compartments. |
| Bioavailability | Bioavailability is 100% when administered intravenously. Not applicable for oral, intramuscular, or other routes; Aminosyn 10% is for IV use only. |
| Onset of Action | For intravenous infusion, the onset of clinical effect (protein synthesis, nitrogen balance improvement) occurs within 1–2 hours of initiation, but measurable metabolic effects (e.g., increased amino acid levels) appear within 15–30 minutes. |
| Duration of Action | Duration of action is proportional to infusion duration. After discontinuation, plasma amino acid levels decline to baseline within 4–6 hours. Metabolic effects (e.g., improved nitrogen balance) may persist for 12–24 hours due to ongoing protein synthesis. |
| Molecular Weight | 173 |
Intravenous infusion: 1 to 1.5 g/kg/day (equivalent to 10 to 15 mL/kg/day of 10% solution) for adult patients with normal nutritional status; adjust based on metabolic needs.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR 30-59 mL/min: reduce dose to 0.8-1.0 g/kg/day. For GFR 15-29 mL/min: 0.6-0.8 g/kg/day. For GFR <15 mL/min or dialysis: 0.5-0.6 g/kg/day; monitor for azotemia. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose by 30-50% and use a formulation with higher branched-chain amino acids. Child-Pugh Class C: avoid or use with extreme caution, adjust based on ammonia levels. |
| Pediatric use | Infants (0-1 year): 2-3 g/kg/day (20-30 mL/kg/day). Children (1-12 years): 1.5-2.5 g/kg/day (15-25 mL/kg/day). Adolescents: 1-1.5 g/kg/day (10-15 mL/kg/day). Administer as continuous IV infusion. |
| Geriatric use | Initiate at lower end of dosing range (0.8-1 g/kg/day) due to reduced renal function and increased risk of fluid overload; monitor serum electrolytes and renal function closely. |
| 1st trimester | Aminosin 10% (pH6) is indicated for parenteral nutrition during pregnancy when oral or enteral nutrition is inadequate. No known teratogenic effects. |
| 2nd trimester | Safe for supplementation of essential amino acids during parenteral nutrition. Use only if clearly needed. |
| 3rd trimester | Monitor maternal nutritional status and fetal growth; generally safe but avoid excess protein loads. |
Clinical note
Comprehensive clinical and safety monograph for AMINOSYN 10% (PH6) (AMINOSYN 10% (PH6)).
| Placental transfer | Amino acids cross the placenta via active transport; transfer is physiological and dose-dependent. No specific risk data for this formulation. |
| Breastfeeding | Excretion into breast milk is minimal due to rapid metabolism and low molecular weight. Considered compatible with breastfeeding when used for essential nutritional support. |
| Lactation Rating | L1 (Safe) |
| Teratogenic Risk | Amino acids are essential nutrients; no teratogenic risk is known when used at recommended doses. However, safety during pregnancy has not been established through controlled studies. First trimester: No evidence of fetal harm. Second/third trimester: Use only if clearly needed; monitor maternal and fetal status. |
| Fetal Monitoring | Monitor maternal electrolyte, acid-base balance, renal function (BUN, creatinine), liver enzymes, and serum ammonia. Fetal monitoring as clinically indicated. |
| Fertility Effects | No known adverse effects on fertility. Amino acids are essential nutrients required for normal reproductive function. |
■ FDA Black Box Warning
None
| Serious Effects |
Severe hepatic failureInborn errors of amino acid metabolism (e.g., maple syrup urine disease)Severe uremiaAnuria
| Precautions | Risk of hyperammonemia, especially in patients with hepatic impairment, Risk of metabolic acidosis, Risk of fluid overload and electrolyte imbalances, Monitor for signs of infection or phlebitis at infusion site, Use with caution in patients with renal insufficiency as may worsen azotemia |
| Food/Dietary | No specific food interactions. However, since this is used in parenteral nutrition, oral intake may be contraindicated. Adjustments may be needed if transitioning to oral feeding. |
| Clinical Pearls | Aminosyn 10% (pH 6) is a crystalline amino acid solution used for parenteral nutrition. Monitor serum electrolytes, BUN, and ammonia levels due to risk of metabolic abnormalities. Adjust infusion rate to avoid hyperglycemia or hypoglycemia. Use with caution in renal or hepatic impairment. Check for compatible additives and avoid mixing with lipids in the same container unless validated. |
| Patient Advice | Report any signs of infection at the IV site, such as redness, swelling, or pain. · Inform your healthcare provider if you experience nausea, vomiting, or dizziness. · This solution provides essential nutrients; do not stop treatment without consulting your doctor. · Keep an eye on your blood sugar levels if you have diabetes. · Do not take any other nutritional supplements without medical advice. |
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