CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive clinical and safety monograph for CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER (CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER).
This formulation provides a balanced mixture of amino acids, dextrose, electrolytes, and calcium for parenteral nutrition. Amino acids serve as substrates for protein synthesis; dextrose provides caloric energy; electrolytes maintain acid-base and fluid balance; calcium is essential for bone mineralization and neuromuscular function.
| Metabolism | Amino acids undergo hepatic deamination and transamination; dextrose is metabolized via glycolysis and oxidative phosphorylation; electrolytes are regulated by renal and gastrointestinal mechanisms; calcium is distributed in bone and soft tissues. |
| Excretion | Renal: amino acids and dextrose metabolites are excreted renally; calcium and electrolytes are also cleared renally. Biliary/fecal: negligible. |
| Half-life | Variable; amino acids have half-lives of minutes to hours; dextrose is rapidly cleared (half-life < 30 min). No terminal elimination half-life defined for mixture. |
| Protein binding | Amino acids: minimal (10-20%); calcium: ~40% bound to albumin; dextrose: not bound. |
| Volume of Distribution | Amino acids: 0.5-1.0 L/kg (total body water); calcium: 0.2-0.3 L/kg; dextrose: 0.2 L/kg (extracellular fluid). |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: immediate upon infusion initiation; protein synthesis begins within minutes; blood glucose elevation within 5 minutes. |
| Duration of Action | Duration depends on infusion rate; metabolic effects persist for 1-2 hours after cessation; glucose levels return to baseline within 1-2 hours. |
| Molecular Weight | Not applicable (mixture of multiple components). Average molecular weight of amino acids: ~140 Da; dextrose: 180.16 Da; electrolytes: various. |
Dose is patient-specific based on caloric and electrolyte needs. Typical adult: 500-3000 mL intravenously over 24 hours; contains 25% dextrose (250 g/L) and 5% amino acids. Infuse via central line due to high osmolarity.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated or dose-reduce in severe renal impairment (GFR <30 mL/min) due to risk of fluid overload and electrolyte imbalances. Monitor potassium, phosphorus, and magnesium closely. |
| Liver impairment | Use with caution in severe hepatic impairment (Child-Pugh class C). May worsen hepatic encephalopathy due to amino acid load; consider specialized formulations. |
| Pediatric use | Dose individualized; typical infusion rate: 0.5-8 mg/kg/min dextrose equivalent. Calculate based on weight (kg), fluid requirements, and nutritional goals. Avoid in neonates with hyperbilirubinemia. |
| Geriatric use | Start at low end of dose range, monitor for fluid overload and electrolyte disturbances due to decreased renal function and comorbidities. Use cautious infusion rates. |
| 1st trimester | CLINIMIX E 5/25 is a parenteral nutrition solution. No specific fetal risks are known with balanced amino acid and dextrose solutions. Use if clinically indicated, as severe maternal malnutrition carries risks. Monitor for electrolyte imbalances, and ensure adequate vitamins/minerals. Caution in hyperglycemia or fluid overload. |
| 2nd trimester | Same as T1. Parenteral nutrition may be necessary in cases of severe hyperemesis, gastrointestinal dysfunction, or other conditions. Use with close monitoring of maternal glucose, electrolytes, and fluid balance. |
| 3rd trimester | Same as T2. Maternal hypoglycemia or electrolyte disturbances may affect fetal wellbeing. Use under specialist guidance. Includes calcium, which is generally safe but monitor for hypercalcemia. |
Clinical note
Comprehensive clinical and safety monograph for CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER (CLINIMIX E 5/25 SULFITE FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER).
| Placental transfer | Evidence: Parenteral nutrition components (amino acids, dextrose, electrolytes) are all known to cross the placenta. However, these are physiologic substances normally transferred. The solution is used to correct or prevent maternal deficiencies; thus, transfer may benefit the fetus. No specific data on the intact formulation, but individual components have low-moderate placental transfer depending on maternal levels. |
| Breastfeeding | CLINIMIX E 5/25 components (amino acids, dextrose, electrolytes) are normally present in human milk. Administration to a breastfeeding mother is not expected to cause adverse effects in the infant. However, maternal electrolyte disturbances or hyperglycemia could affect milk composition. Use with caution and monitor maternal glucose and electrolytes. Dextrose may transiently increase milk glucose, but not clinically significant. |
| Lactation Rating | L1 - Safe |
| Teratogenic Risk | CLINIMIX E 5/25 contains dextrose, amino acids, electrolytes, and calcium. Dextrose at high concentrations may cause maternal hyperglycemia, potentially leading to fetal hyperinsulinemia and neonatal hypoglycemia, but no direct teratogenicity in first trimester. No specific teratogenic risks from amino acids or electrolytes at therapeutic doses. Calcium administration may affect fetal calcium homeostasis if maternal levels are markedly elevated. Overall, risk is related to underlying maternal condition rather than direct drug effect. |
| Fetal Monitoring | Monitor maternal blood glucose, electrolytes (including ionized calcium), and acid-base status. Assess for signs of fluid overload or electrolyte imbalance. Fetal monitoring as per gestational age for signs of distress, including non-stress test and biophysical profile if clinically indicated. Monitor neonatal blood glucose after delivery. |
| Fertility Effects | No known adverse effects on fertility. Underlying conditions requiring parenteral nutrition may impact fertility, but CLINIMIX E 5/25 itself does not impair reproductive function. |
■ FDA Black Box Warning
Not for use in patients with known hypersensitivity to any component. Contains aluminum that may be toxic with prolonged administration in renal impairment.
| Serious Effects |
Known hypersensitivity to any component (amino acids, dextrose, or electrolytes)Inborn errors of amino acid metabolism (e.g., maple syrup urine disease, phenylketonuria)Severe hyperglycemia or diabetes mellitus if glucose is contraindicated (e.g., in hyperosmolar hyperglycemic state)Severe electrolyte abnormalities that cannot be corrected (e.g., severe hypercalcemia, hyperkalemia)Severe hepatic failure (risk of hyperammonemia with amino acid solutions)Anuria or severe renal failure (risk of fluid and electrolyte overload unless renal replacement therapy is used)
| Precautions | Risk of hyperglycemia, fluid overload, electrolyte disturbances, and aluminum toxicity, Monitor serum glucose, electrolytes, liver function, and acid-base status regularly, Use with caution in hepatic or renal impairment, heart failure, and hypercalcemia, Do not administer simultaneously with blood through same tubing |
| Food/Dietary | No direct food interactions as this product is administered intravenously. However, patients receiving parenteral nutrition should not eat or drink unless approved by the dietitian or doctor to avoid aspiration or metabolic imbalances. Enteral intake may affect blood glucose and electrolyte levels. |
| Clinical Pearls | This product is a dual-chamber bag containing amino acids 5%, dextrose 25%, and electrolytes including calcium. The 'Sulfite Free' designation is critical for patients with sulfite sensitivity. Calcium-containing PN must not be co-administered with ceftriaxone due to precipitation risk. Inline filter of 1.2 micron is recommended. Monitor serum calcium, phosphorus, and magnesium closely when adjusting PN. Hepatic function and triglycerides should be assessed if used for long-term nutrition. |
| Patient Advice | This medication provides complete nutrition through your vein; it is not for oral use. · You may need blood tests to monitor your sugar, electrolyte levels, and liver function. · Report any signs of infection (redness, swelling, pain) at the IV site immediately. · Do not stop or change the infusion rate without consulting your doctor. · Tell your healthcare provider about any allergies, especially to sulfites. |
Loading safety data…