CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER

Clinical safety rating: caution

Comprehensive clinical and safety monograph for CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER (CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER).

How it works

Intravenous amino acids and dextrose provide essential nitrogen and calories for protein synthesis and energy metabolism. Electrolytes maintain osmotic balance and cellular function. Calcium is critical for neuromuscular transmission and bone health.

What the body does with it

Metabolism	Amino acids undergo hepatic metabolism and renal excretion of nitrogenous wastes; dextrose is metabolized via glycolysis and oxidative phosphorylation; electrolytes are excreted renally.
Excretion	The amino acids and electrolytes are metabolized or utilized; dextrose is oxidized to CO2 and water. Renal excretion of nitrogen is ~60-80% as urea, with minor losses in feces (5-10%) and skin (2-5%). Electrolytes are excreted primarily renally.
Half-life	Not applicable as a single entity; components have distinct half-lives: dextrose ~1.5-2 hours (glucose); amino acids ~5-10 minutes; electrolytes vary (e.g., calcium ~2-3 hours). Clinical context: continuous infusion achieves steady state.
Protein binding	Minimal for most components (<10% for amino acids and electrolytes); calcium ~40% bound to albumin.
Volume of Distribution	Not applicable as a mixture; individual components vary: dextrose Vd ~0.2 L/kg, electrolytes distribute in total body water (e.g., sodium 0.6 L/kg).
Bioavailability	Intravenous: 100%.
Onset of Action	Intravenous: immediate once infusion begins; metabolic effects (e.g., glucose utilization) within minutes.
Duration of Action	Duration depends on infusion rate; effects persist during infusion and decline rapidly after cessation. For parenteral nutrition, continuous infusion maintains steady state over 24 hours.

Classification & Brands

Dosing & administration

Intravenous infusion: Adult dose is based on protein and caloric requirements. Typical dose: 1-2 L/day of this 4.25% amino acid, 20% dextrose solution, providing approximately 4.25 g amino acid/100 mL and 680 kcal/L. Infusion rate should be adjusted to avoid hyperglycemia, usually starting at 25-50 mL/hr and increasing gradually.

Dosage form	INJECTABLE
Renal impairment	Contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) unless on dialysis. In moderate impairment (eGFR 30-59 mL/min/1.73 m²), reduce dose by 50% and monitor electrolytes.
Liver impairment	Contraindicated in patients with severe hepatic encephalopathy. In Child-Pugh Class B or C, use with caution; reduce dose by 50% and monitor ammonia levels.
Pediatric use	Dose based on weight (kg): 2-3 g amino acids/kg/day and 10-20 g dextrose/kg/day. Typical infusion rate: 0.1-0.2 mL/kg/hr initially, titrated to clinical response. Not recommended for neonates due to high dextrose concentration.
Geriatric use	No specific dose adjustment; use lower initial infusion rates (25-50 mL/hr) due to reduced renal and hepatic function. Monitor glucose and electrolytes closely.

Use during pregnancy

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

Clinical note

Breastfeeding

No data on excretion of CLINIMIX E components in breast milk. Dextrose and amino acids are normal milk constituents. Calcium and other electrolytes are present in milk, but parenteral administration may increase levels. M/P ratio not available. Caution: potential for maternal hyperglycemia or electrolyte imbalances affecting milk composition. Use only if clearly needed, and monitor infant for hypoglycemia or electrolyte disturbances.

Teratogenic Risk

CLINIMIX E 4.25/20 is a parenteral nutrition solution containing amino acids, electrolytes, and dextrose. There are no adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted with this combination product. Dextrose at high doses may cause fetal hyperglycemia and hyperinsulinemia, potentially leading to neonatal hypoglycemia. Electrolyte imbalances (e.g., calcium) can affect fetal development. Use only if clearly needed and monitor maternal glucose and electrolytes closely. First trimester risks are theoretical; second and third trimester risks include fetal hyperglycemia and electrolyte disturbances.

Warnings & precautions

■ FDA Black Box Warning

Not for use in patients with known hypersensitivity to any component; risk of metabolic acidosis, hyperglycemia, or electrolyte imbalances if not monitored appropriately.

Side Effect Profile

Serious Effects

Absolute Contraindications

Known hypersensitivity to any ingredient, severe hyperglycemia, hyperkalemia, hypercalcemia, anuria, or inborn errors of amino acid metabolism.

Clinical Precautions

Precautions

Monitor for signs of infection, hyperglycemia, electrolyte disturbances, and fluid overload. Use with caution in patients with renal impairment, hepatic disease, or diabetes. Do not administer simultaneously with blood products through same IV line.

Clinical Tips & Counseling

Drug interactions

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