AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER (AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER).

How it works

Aminogen (amino acids) provide substrate for protein synthesis; dextrose provides caloric energy; electrolytes maintain acid-base and fluid balance; phosphate is essential for cellular metabolism and buffering.

What the body does with it

Metabolism	Amino acids are deaminated and metabolized via hepatic transamination and urea cycle; dextrose undergoes glycolysis and oxidation; electrolytes are excreted renally; phosphate is incorporated into energy molecules.
Excretion	The components of AMINOSYN II (amino acids) and dextrose are primarily metabolized; excess nitrogen is excreted renally as urea. Dextrose is completely oxidized. Electrolytes are excreted mainly renally. Biliary/fecal elimination is negligible for amino acids and dextrose (<2%).
Half-life	Amino acids have a terminal elimination half-life of approximately 1.5–2 hours in healthy adults, reflecting rapid metabolic clearance. In renal impairment, half-life may be prolonged due to accumulation of nitrogenous waste.
Protein binding	Amino acids are minimally protein-bound (<15%) to albumin and globulins; dextrose not bound. Electrolytes are not protein-bound.
Volume of Distribution	Volume of distribution for total amino acids is approximately 0.3–0.4 L/kg, reflecting distribution primarily into extracellular fluid and lean body mass. Clinical meaning: indicates rapid equilibration with interstitial spaces.
Bioavailability	Intravenous: 100% bioavailability. Oral/enteral: not applicable; this product is for intravenous use only.
Onset of Action	Intravenous: Onset of nutritional support (nitrogen balance improvement) occurs within 24–48 hours of continuous infusion; plasma amino acid levels peak immediately post-infusion.
Duration of Action	Duration of nutritional effect persists as long as infusion continues; upon discontinuation, plasma amino acid levels decline rapidly (hours). Clinical effects on nitrogen balance require sustained administration for days.

Classification & Brands

Dosing & administration

Intravenous infusion; typical adult dose: 1-1.5 g amino acids/kg/day, with dextrose providing 10% final concentration. Adjusted to meet protein and caloric needs.

Dosage form	INJECTABLE
Renal impairment	GFR < 30 mL/min: reduce amino acid dose to 0.6-0.8 g/kg/day; monitor phosphorus and electrolytes. GFR 30-60 mL/min: may use standard dosing with close monitoring.
Liver impairment	Child-Pugh class B or C: reduce amino acid dose by 50% or use specialized formulation (e.g., hepatamine). Monitor for encephalopathy.
Pediatric use	Weight-based: neonates: 2-3 g amino acids/kg/day; children: 1-2 g/kg/day. Adjust dextrose concentration for glucose tolerance.
Geriatric use	Start at lower end of adult dosing (1 g amino acids/kg/day) due to reduced renal function; monitor fluid and electrolyte status carefully.

Use during pregnancy

1st trimester	Consult provider
2nd trimester	Consult provider
3rd trimester	Consult provider

Clinical note

Breastfeeding

Not known whether this drug is excreted in human milk. Caution should be exercised when administered to a nursing woman. M/P ratio not available. Consider benefits of breastfeeding and importance of drug to mother.

Teratogenic Risk

Aminosyn II 4.25% w/ Electrolytes and Adjusted Phosphate in Dextrose 10% is a parenteral nutrition solution. No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Should be used during pregnancy only if clearly needed. Potential risks include electrolyte imbalances, fluid overload, and hyperglycemia which may affect fetal development. Use in third trimester may be associated with neonatal hypoglycemia if maternal hyperglycemia occurs.

Warnings & precautions

■ FDA Black Box Warning

Not for use in patients with metabolic acidosis, hyperglycemic coma, or severe electrolyte disorders. Do not administer concomitantly with blood through the same administration set due to risk of hemolysis.

Side Effect Profile

Serious Effects

Absolute Contraindications

["Hypersensitivity to any component","Severe metabolic acidosis","Hyperglycemic coma","Severe electrolyte disorders","Anuria or severe renal failure (relative)","Liver failure with hyperammonemia (relative)"]

Clinical Precautions

Precautions	Monitor for hyperglycemia, hyperammonemia, metabolic acidosis, and fluid overload. Risk of infection from catheter-related sepsis. Adjust dose in renal/hepatic impairment. Refeeding syndrome risk in malnourished patients. Contains aluminum; may accumulate in renal failure.
Food/Dietary	No direct food interactions, but total caloric and nutrient intake from other sources must be accounted for to avoid overfeeding or electrolyte imbalances.

Clinical Tips & Counseling

Drug interactions

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