CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive clinical and safety monograph for CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER (CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER).
Provides a source of amino acids and dextrose for parenteral nutrition; amino acids support protein synthesis, dextrose provides calories. Electrolytes maintain fluid and electrolyte balance.
| Metabolism | Amino acids are primarily metabolized in the liver via transamination and deamination; dextrose undergoes glycolysis and oxidation. Electrolytes are not metabolized but are excreted or retained as needed. |
| Excretion | Amino acids: primarily deaminated in liver, urea excreted renally. Dextrose: metabolized to CO2 and water, with excess excreted renally as glucose. Electrolytes: renal excretion. No significant biliary/fecal elimination for components. |
| Half-life | Amino acids: 0.5-1 hour (rapid clearance from plasma). Dextrose: effectively infinite as continuous infusion maintains steady state. Electrolytes: dependent on renal function and tubular handling. |
| Protein binding | Amino acids: minimal (<10%, primarily albumin). Dextrose: not protein-bound. Electrolytes: variable (calcium ~50% bound to albumin; magnesium ~30% bound; others minimal). |
| Volume of Distribution | Amino acids: 0.1-0.3 L/kg (primarily extracellular fluid). Dextrose: 0.2-0.3 L/kg (total body water). Electrolytes: calcium 0.4-0.5 L/kg; magnesium 0.3-0.5 L/kg; others distributed in extracellular fluid. |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: immediate (seconds to minutes) for caloric and electrolyte effects; protein synthesis begins within 30-60 minutes. |
| Duration of Action | Duration corresponds to infusion period and post-infusion metabolic processing (2-4 hours for amino acids; glucose levels return to baseline within 2 hours after infusion stops). |
| Molecular Weight | Varies (mixture: amino acids ~75-204 Da, dextrose 180 Da, electrolytes dissociated). Average molecular weight not applicable. |
Intravenous infusion. Dose is based on nutritional requirements and metabolic tolerance. Typical adult dose: 1-2 L per day (providing 4.25% amino acids and 10% dextrose) at a rate not exceeding 4 mg/kg/min of dextrose. Administer via central line or peripheral vein if osmolarity permits.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73 m²) unless patient is receiving renal replacement therapy. For patients with eGFR 30-60 mL/min/1.73 m², reduce total protein/amino acid intake to 0.6-0.8 g/kg/day and monitor electrolytes, particularly potassium, phosphate, and magnesium. For eGFR > 60, no adjustment typically needed but monitor fluid/electrolyte balance. |
| Liver impairment | Use with caution in hepatic impairment. For Child-Pugh Class A (mild): standard dosing with monitoring of ammonia levels. Child-Pugh B (moderate): reduce amino acid dose by 50% and consider branched-chain amino acid enriched solutions; monitor for hepatic encephalopathy. Child-Pugh C (severe): avoid use unless essential; if used, start at 25% of standard dose with frequent ammonia monitoring. |
| Pediatric use | Weight-based dosing: initial infusion at 0.5-1 g/kg/day of amino acids, increase by 0.5 g/kg/day to target 2-3 g/kg/day for infants and 1-2 g/kg/day for older children. Dextrose: start at 4-8 mg/kg/min, titrate based on glucose tolerance. Maximum dextrose infusion rate: 12 mg/kg/min for neonates, 14 mg/kg/min for infants. Adjust volume to meet fluid requirements. |
| Geriatric use | Start at lower end of dosing range (e.g., initial rate 1 mL/kg/hour). Monitor renal function and adjust protein content to eGFR. Maximum dextrose rate: 2-3 mg/kg/min in patients >70 years to avoid hyperglycemia. Limit total fluid volume to 20-30 mL/kg/day unless fluid overload contraindicates. |
| 1st trimester | Generally considered safe when used as nutritional support. Contains amino acids, electrolytes, and dextrose; no known teratogenic effects. Use only if clearly needed. |
| 2nd trimester | Safe for maternal nutrition during pregnancy. Monitor fluid and electrolyte balance. |
| 3rd trimester | Safe for maternal nutrition; avoid fluid overload. Use with caution in preeclampsia or gestational hypertension. |
Clinical note
Comprehensive clinical and safety monograph for CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER (CLINIMIX E 4.25/10 SULFITE FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER).
| Placental transfer | Amino acids and electrolytes cross the placenta; dextrose crosses readily. Not associated with fetal harm. |
| Breastfeeding | Components are normally present in breast milk. No known adverse effects on infant. Compatible with breastfeeding when used for maternal nutritional support. |
| Lactation Rating | Safe |
| Teratogenic Risk | CLINIMIX E 4.25/10 is a parenteral nutrition solution containing amino acids, dextrose, electrolytes, and calcium. No specific teratogenic risks are well-documented for the combination. Dextrose at high doses may cause fetal hyperglycemia and macrosomia if maternal glucose control is impaired. Calcium is essential for fetal development; excess could theoretically cause hypercalcemia-related effects. Overall, no specific malformation pattern is established. Trimester-specific risks are not defined; use is justified only if maternal benefits outweigh potential fetal risks. |
| Fetal Monitoring | Monitor maternal blood glucose, electrolytes (particularly calcium, phosphate, potassium, magnesium), renal function, and liver function. Assess fluid balance. Fetal monitoring includes growth scans and amniotic fluid assessment if prolonged use. Observe for signs of electrolyte imbalance or metabolic complications. |
| Fertility Effects | No known adverse effects on fertility. The components are physiological substances. Any impact would be indirect via underlying maternal disease (e.g., malnutrition) requiring parenteral nutrition. |
■ FDA Black Box Warning
Solutions containing aluminum may be toxic; aluminum may reach toxic levels with prolonged parenteral administration in patients with renal impairment. Premature neonates are at increased risk because of immature renal function and aluminum accumulation.
| Serious Effects |
Hypersensitivity to any componentSevere hyperglycemiaHepatic comaUremia (without dialysis)Elevated serum electrolytes (e.g., hyperkalemia, hypercalcemia)
| Precautions | Risk of infection or sepsis due to catheter-related infections, Metabolic complications including hyperglycemia, hypoglycemia, hyperosmolar syndrome, electrolyte imbalances, and acid-base disturbances, Hepatic and renal function monitoring required, Aluminum toxicity risk, especially in premature neonates and renal impairment, Not for peripheral administration due to high osmolarity (>900 mOsm/L) |
| Food/Dietary | Food interactions are not clinically relevant for intravenous administration. However, oral intake may be restricted due to the patient's condition (e.g., NPO status). |
| Clinical Pearls | Monitor serum electrolytes, glucose, and acid-base status frequently during infusion. Use inline filter (1.2 micron) due to calcium-phosphate precipitation risk. Avoid simultaneous blood transfusions through same line. Do not administer if lipid emulsion is needed concurrently. Adjust infusion rate based on tolerance and metabolic status. |
| Patient Advice | This solution provides nutrition, fluids, and electrolytes through a vein. · Report any signs of infection at IV site, such as redness, swelling, or pain. · Inform your healthcare provider if you experience headache, nausea, or shortness of breath. · Do not stop the infusion suddenly without consulting your doctor. · This product contains calcium and should not be mixed with certain other IV solutions. |
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