CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER (CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER).
CLINIMIX E is a parenteral nutrition solution providing amino acids, electrolytes, and dextrose for intravenous infusion. It supplies essential and non-essential amino acids for protein synthesis, dextrose as a caloric source, and electrolytes for maintenance of acid-base balance and cellular function. Calcium is included for bone health and neuromuscular function.
| Metabolism | Amino acids are metabolized via transamination and deamination pathways; dextrose is metabolized via glycolysis and the citric acid cycle; electrolytes are not metabolized but are utilized in physiological processes. |
| Excretion | Excretion depends on amino acid and electrolyte composition; nitrogen waste is eliminated renally as urea. Calcium and magnesium are primarily renally excreted; potassium is mostly renally eliminated. Dextrose is metabolized to CO2 and water. In renal impairment, accumulation may occur. |
| Half-life | Not applicable as a single entity; components have variable half-lives: dextrose ~1-2h, amino acids ~1-3h for distribution, electrolytes vary. No terminal half-life defined. |
| Protein binding | Low for amino acids and electrolytes; calcium ~40% bound to albumin, magnesium ~30% bound, potassium not protein-bound. |
| Volume of Distribution | Not defined as a composite; amino acids distribute into total body water (0.5-0.6 L/kg), calcium distributes into extracellular fluid (~0.2 L/kg), potassium intracellularly (~4 L/kg). |
| Bioavailability | 100% (intravenous administration). |
| Onset of Action | Intravenous: Metabolic effects begin within 30-60 minutes; electrolyte effects onset within minutes. |
| Duration of Action | Duration depends on infusion rate and metabolic needs; nutritional support requires continuous infusion. Electrolyte effects last 2-4 hours after cessation. |
Administer intravenously. Dose is individualized based on patient's metabolic requirements, clinical condition, and tolerance. Typical adult dose: 500-2000 mL per day, infused at a rate not exceeding 2-3 mL/kg/hour (or 2 mg/kg/min of amino acids), equivalent to 1-1.5 g/kg/day of amino acids and 3-7 g/kg/day of dextrose.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in severe renal failure (eGFR < 30 mL/min/1.73 m²) without renal replacement therapy; if used, reduce dose by 50% for moderate impairment (eGFR 30-59 mL/min/1.73 m²) and monitor electrolytes. |
| Liver impairment | Contraindicated in severe hepatic impairment (Child-Pugh class C); use with caution in Child-Pugh class B (reduce amino acid dose by 50-75%); no adjustment for Child-Pugh class A. |
| Pediatric use | Dose based on body weight: Amino acids: 1-3 g/kg/day; Dextrose: 5-20 g/kg/day. Initiate at lower end and increase gradually. Typical infusion rate: 1-2 mL/kg/hour, titrate to blood glucose and metabolic tolerance. Not recommended for neonates without risk-benefit assessment. |
| Geriatric use | No specific dose adjustment, but use with caution due to potential age-related decline in renal function. Monitor fluid balance and renal function; start at lower doses (e.g., 500 mL/day) and adjust based on tolerance and clinical response. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER (CLINIMIX E 4.25/5 SULFITE FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER).
| Breastfeeding | Safety in breastfeeding is not established. Components excrete into milk in low amounts; no specific M/P ratio available. Parenteral nutrition use in lactating women should be with caution. Monitor infant for electrolyte imbalance. |
| Teratogenic Risk | CLINIMIX E 4.25/5 contains amino acids, dextrose, and electrolytes, including calcium. No teratogenic effects have been reported in animal or human studies with standard components at physiological concentrations. However, calcium administration in the third trimester may be associated with neonatal hypocalcemia if maternal hypercalcemia occurs. No specific fetal risks are identified for the first two trimesters when used as indicated for parenteral nutrition. |
■ FDA Black Box Warning
Not applicable. CLINIMIX E does not carry an FDA black box warning.
| Serious Effects |
["Hypersensitivity to any component of the solution.","Severe electrolyte disturbances or metabolic acidosis.","Anuria or severe renal impairment (unless dialyzed adequately).","Hepatic coma or severe hepatic insufficiency.","Uncorrected hyperglycemia or hyperosmolar coma."]
| Precautions | ["Risk of infection due to catheter-related bloodstream infections; strict aseptic technique required.","Metabolic complications including hyperglycemia, hypoglycemia, electrolyte imbalances, and acid-base disturbances.","Hepatic and renal function monitoring required; adjust infusion rates accordingly.","Aluminum toxicity risk in patients with renal impairment; prolonged use may lead to bone disease.","Do not administer simultaneously with blood products through the same infusion line."] |
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| Fetal Monitoring | Monitor maternal electrolytes, glucose, acid-base balance, renal and hepatic function, and fluid status. In pregnancy, monitor for signs of hypercalcemia (e.g., nausea, vomiting) and fetal heart rate. Assess for fluid overload. Serial fetal growth ultrasound recommended for prolonged use. |
| Fertility Effects | No adverse effects on fertility reported with standard components. Malnutrition correction may improve fertility. High glucose or electrolyte disturbances could theoretically impact fertility, but no direct evidence. |