CLINIMIX E 4.25/20 SULFITE FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive 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).
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.
| 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. |
| Molecular Weight | Not applicable (mixture); each component has its own MW. Dextrose: 180.16 Da; amino acids: vary (e.g., 75-204 Da); electrolytes: <100 Da. |
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. |
| 1st trimester | Clinimix E 4.25/20 is a combination of amino acids, dextrose, and electrolytes. Parenteral nutrition should be used during pregnancy only if clearly needed. No well-controlled studies exist; potential benefits may warrant use despite risks. |
| 2nd trimester | Same as trimester 1. Dextrose may affect maternal glucose levels; monitor for hyperglycemia. Amino acids and electrolytes should be adjusted to meet increased requirements. |
| 3rd trimester | Same as trimester 1. Use with caution in preeclampsia or gestational diabetes. Dextrose load may cause fetal hyperglycemia and insulin response. |
Clinical note
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).
| Placental transfer | Amino acids and dextrose cross the placenta. Amino acids are actively transported to fetus; dextrose crosses by facilitated diffusion. Electrolytes cross as normal. Degree of transfer depends on maternal concentrations and placental function. |
| Breastfeeding | Components (amino acids, dextrose, electrolytes) are normal blood constituents and are excreted into breast milk in small amounts. Parenteral nutrition use in lactating women is unlikely to harm the infant. Monitor infant for gastrointestinal disturbances or excessive weight gain. Benefit to mother should outweigh any theoretical risk. |
| Lactation Rating | L2 (Safer) |
| 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. |
| Fetal Monitoring | Monitor maternal serum glucose, electrolytes (sodium, potassium, calcium, magnesium, phosphate), renal function, liver function, and acid-base status regularly. Fetal monitoring: assess fetal growth and well-being via ultrasound if prolonged use. Monitor for maternal hyperglycemia, especially with gestational diabetes. Assess neonatal blood glucose and electrolytes at birth if prolonged infusion near delivery. |
| Fertility Effects | No specific fertility data for this combination. Parenteral nutrition may correct nutritional deficiencies and improve fertility in malnourished women. Electrolyte imbalances or metabolic disturbances could potentially impair ovulation or spermatogenesis. Dextrose infusions may affect insulin levels and hormonal balance. No known direct reproductive toxicity. |
■ 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.
| Serious Effects |
Hypersensitivity to any componentSevere hepatic insufficiency or hepatic comaSevere renal failure (oliguria, anuria) without dialysisHyperglycemia or hyperosmolar comaHyperkalemia, hypercalcemia, hypermagnesemiaSevere fluid overload or pulmonary edemaInborn errors of amino acid metabolismFructose or sorbitol intolerance (dextrose may be cross-reactive in some formulations)
| 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. |
| Food/Dietary | No oral food interactions as this is an intravenous formulation. However, if transitioning to oral intake, monitor for refeeding syndrome and adjust accordingly. Avoid simultaneous administration of medications or other additives unless compatibility confirmed. |
| Clinical Pearls | This total parenteral nutrition formulation provides 4.25% amino acids and 20% dextrose with electrolytes and calcium. Do not add additional calcium or phosphate without compatibility check to avoid precipitation. Use a dedicated line with an inline filter (1.2 micron for lipid-containing, 0.22 micron for non-lipid). Monitor serum glucose, electrolytes, renal and hepatic function. Adjust rate gradually to prevent hyperglycemia or rebound hypoglycemia. Note sulfite-free for sulfite-sensitive patients. |
| Patient Advice | This solution is given intravenously to provide nutrition when you cannot eat. · Report any signs of infection at the IV site (redness, swelling, pain) or fever. · You will have regular blood tests to check your sugar, electrolyte, and organ function. · Do not stop or change the infusion rate yourself; it must be adjusted gradually. · Notify your nurse if you experience headache, nausea, sweating, or rapid heartbeat, which may indicate low blood sugar. |
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