AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER (AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER).

How it works

Amino acids serve as substrates for protein synthesis and nitrogen balance; dextrose provides caloric energy for metabolic processes; electrolytes maintain fluid and electrolyte homeostasis.

What the body does with it

Metabolism	Amino acids undergo hepatic deamination and transamination; dextrose undergoes glycolysis and oxidative metabolism via insulin-dependent pathways; electrolytes are excreted or reabsorbed renally.
Excretion	Renal excretion of amino acids and dextrose metabolites; >90% of infused amino nitrogen is excreted renally as urea, with minimal biliary/fecal elimination.
Half-life	Amino acids: variable, ~10-30 min for most; dextrose: ~1-2 h terminal half-life in healthy adults, prolonged in renal impairment.
Protein binding	Amino acids: <10% bound to plasma proteins (albumin); dextrose: not protein-bound.
Volume of Distribution	Amino acids: 0.5-0.8 L/kg, distributing into total body water; dextrose: ~0.2 L/kg, primarily extracellular.
Bioavailability	Intravenous: 100% bioavailability for both amino acids and dextrose.
Onset of Action	Intravenous: immediate upon infusion, with plasma amino acid levels rising within minutes.
Duration of Action	Intravenous: duration of metabolic effect lasts as long as infusion continues; post-infusion, effects decline rapidly (hours).

Classification & Brands

Dosing & administration

Intravenous infusion: 500 mL to 2 L per day, administered via central line at a rate not exceeding 1 mL/min for initial 30 minutes, then increase to 2 mL/min if tolerated. Dose based on patient's protein and energy requirements; typical protein equivalent: 4.25 g/100 mL.

Dosage form	INJECTABLE
Renal impairment	Contraindicated in severe renal insufficiency (GFR <30 mL/min) unless dialyzing; in moderate renal impairment (GFR 30-59 mL/min), reduce protein content by 50% and monitor electrolytes. No specific dose reduction for GFR 60-90 mL/min.
Liver impairment	Avoid in decompensated cirrhosis (Child-Pugh class C) due to high amino acid load; in class B, use with caution, reduce infusion rate by 50% and monitor ammonia levels. Class A: no adjustment required.
Pediatric use	Dose based on body weight: 1-2 g amino acids per kg per day and 7.5-15 g dextrose per kg per day. Administer via central line. Typical starting rate: 0.5-1 mL/kg per hour, increase gradually. Not recommended for neonates due to electrolyte composition.
Geriatric use	Start at lower rates (0.5-1 mL/min) and monitor renal function and glucose tolerance closely. May require reduced total volume due to risk of fluid overload. No specific dose reduction but individualized based on comorbid conditions.

Use during pregnancy

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

Clinical note

Breastfeeding	No data on M/P ratio. The components (amino acids, dextrose, electrolytes) are normal blood constituents and are likely transferred into breast milk in small amounts. Use with caution; consider risks and benefits.
Teratogenic Risk	No specific teratogenic risk data exist for this combination product. Dextrose and amino acids are essential nutrients; calcium is required for fetal development. However, electrolyte imbalances may pose risks. In general, intravenous administration during pregnancy should be guided by maternal condition and fetal monitoring.

Warnings & precautions

■ FDA Black Box Warning

NOT FOR DIRECT INTRAVENEOUS INFUSION: Requires addition of vitamins, trace elements, and possible lipid emulsion prior to administration. Risk of hypersensitivity reactions including anaphylaxis.

Side Effect Profile

Serious Effects

Absolute Contraindications

Inborn errors of amino acid metabolism (e.g., maple syrup urine disease, phenylketonuria), severe hyperglycemia, uncorrected electrolyte imbalances, severe hepatic failure with hyperammonemia, and hypersensitivity to any component.

Clinical Precautions

Precautions	Monitor serum electrolytes, glucose, and liver function tests. Risk of hyperglycemia, electrolyte imbalances, and fluid overload in renal/cardiac impairment. Avoid sudden withdrawal to prevent hypoglycemia.
Food/Dietary	No oral food interactions as this is administered intravenously. However, if transitioning to oral intake, monitor for refeeding syndrome; start with low carbohydrate, low sodium intake and supplement phosphorus, potassium, and magnesium as needed.

Clinical Tips & Counseling

Drug interactions

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