AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER (AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER).

How it works

Provides essential amino acids and dextrose for parenteral nutrition; amino acids serve as substrates for protein synthesis, while dextrose supplies caloric energy.

What the body does with it

Metabolism	Amino acids undergo hepatic deamination and enter the urea cycle; dextrose is metabolized via glycolysis and the Krebs cycle. Electrolytes are incorporated into body pools or excreted renally.
Excretion	Renal, primarily as urea and free amino acids; minimal biliary/fecal elimination.
Half-life	Variable, dependent on individual amino acids and metabolic state; clinical context reflects continuous infusion without distinct terminal phase.
Protein binding	Negligible; individual amino acids have variable binding but overall <10% bound to albumin.
Volume of Distribution	Approximately 0.3-0.4 L/kg for amino acids; reflects distribution into total body water and intracellular spaces.
Bioavailability	Intravenous: 100%
Onset of Action	Immediate upon IV infusion; plasma amino acid levels rise within minutes.
Duration of Action	Duration of infusion; effects persist as long as infusion continues with rapid decline post-infusion due to metabolism and renal excretion.

Classification & Brands

Dosing & administration

Individualized based on protein and calorie requirements; typical adult dose: 500-2000 mL/day intravenously, infused at a rate not exceeding 200 mL/hour.

Dosage form	INJECTABLE
Renal impairment	For GFR 30-89 mL/min: reduce total amino acid dose to 0.8-1.0 g/kg/day; for GFR <30 mL/min: avoid or use with caution, reduce to 0.6-0.8 g/kg/day with monitoring of electrolytes and acid-base status.
Liver impairment	Child-Pugh class A: no adjustment; Child-Pugh class B: reduce amino acid dose to 0.8-1.0 g/kg/day with branched-chain amino acid supplementation if encephalopathy; Child-Pugh class C: avoid use or use with extreme caution, limited to 0.5-0.8 g/kg/day with monitoring for hepatic encephalopathy.
Pediatric use	Weight-based: initial 1-2 g amino acids/kg/day, increase gradually to 2-3 g/kg/day; infusion rate adjusted based on tolerance; maximum 3 g/kg/day or as per clinical guidelines.
Geriatric use	Start at lower end of dosing range (e.g., 0.8-1.0 g amino acids/kg/day) due to reduced renal function; monitor electrolytes, glucose, and volume status closely; avoid rapid infusion to prevent fluid overload.

Use during pregnancy

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

Clinical note

Breastfeeding

Safety during breastfeeding is not specifically studied for this combination product. Dextrose and electrolytes are normally present in breast milk; excess dextrose may raise maternal glucose and potentially affect milk composition. Calcium is secreted into breast milk, and excessive maternal supplementation could theoretically alter milk calcium levels. The M/P ratio is not known. Use caution and monitor maternal glucose and electrolytes if used during lactation.

Teratogenic Risk

Aminosyn II 3.5% with electrolytes in dextrose 25% with calcium is a combination of amino acids, electrolytes, dextrose, and calcium. Dextrose at high concentrations can cause fetal hyperglycemia and neonatal hypoglycemia if administered near term. Calcium and electrolytes are essential and generally safe at therapeutic doses, but imbalances may affect fetal development. In the first trimester, extreme electrolyte disturbances could theoretically affect organogenesis, but no specific teratogenic risk is established. In the second and third trimesters, risks include maternal hyperglycemia leading to fetal hyperinsulinism, macrosomia, and neonatal hypoglycemia. Calcium administration may involve risk of hypercalcemia, which can cause fetal parathyroid suppression. Overall, the risk profile is dependent on maternal metabolic control and electrolyte balance.

Warnings & precautions

■ FDA Black Box Warning

Not for intravenous infusion in patients with severe electrolyte imbalances, severe renal or hepatic impairment, or metabolic disorders. Risk of hyperglycemia, hyperosmolar syndrome, and fluid/electrolyte imbalances.

Side Effect Profile

Serious Effects

Absolute Contraindications

Severe electrolyte disturbances, severe hepatic failure, severe renal impairment, hyperglycemia, hypersensitivity to any component, infants less than 1 year of age (specific to formulation), inborn errors of amino acid metabolism.

Clinical Precautions

Precautions	Monitor serum glucose, electrolytes, and fluid status closely. Use caution in patients with cardiac, renal, hepatic disease, or diabetes mellitus. Risk of refeeding syndrome in malnourished patients. Contains aluminum that may be toxic with prolonged use.
Food/Dietary	None; this is a parenteral nutrition product and does not interact with oral food. However, concurrent oral nutrition, if any, should be considered.

Clinical Tips & Counseling

Drug interactions

Loading safety data…