CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER (CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER).
Electrolyte and amino acid supplementation to maintain or restore fluid balance, provide calories from dextrose, and supply essential amino acids for protein synthesis; calcium and other electrolytes support physiological functions.
| Metabolism | Dextrose is metabolized via glycolysis and oxidative pathways; amino acids are catabolized in the liver and tissues; electrolytes are handled by the kidneys. |
| Excretion | Renal excretion of amino acids and dextrose metabolites; no significant biliary or fecal elimination. Unused amino acids are deaminated and excreted as urea in urine (approximately 80-90% of nitrogen load). Electrolytes are excreted renally. |
| Half-life | Not applicable as a single entity; amino acids have half-lives ranging from minutes to hours depending on individual amino acid metabolism. Dextrose has a half-life of about 1-2 hours in fasting state, but this formulation is for continuous infusion, so elimination is constant. |
| Protein binding | Amino acids and electrolytes are minimally protein-bound (<5%); no specific binding proteins. Dextrose does not bind to proteins. |
| Volume of Distribution | Amino acids distribute into total body water (approximately 0.6 L/kg). Dextrose distributes into extracellular fluid (approximately 0.2 L/kg). Electrolytes distribute according to their body compartments (e.g., sodium 0.15 L/kg, potassium 0.4 L/kg). |
| Bioavailability | Intravenous only; 100% bioavailability via IV infusion. Not administered via other routes. |
| Onset of Action | Immediate upon IV infusion; nutritional support begins as soon as infusion starts |
| Duration of Action | Continuous nutritional support as long as infusion is maintained; effects on nitrogen balance and blood glucose persist for hours after discontinuation depending on metabolic state |
Intravenous infusion at a rate determined by clinical condition and metabolic requirements. Typical adult initial rate: 100 mL/hr, adjusted based on glucose tolerance and fluid status.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in patients with severe renal impairment (eGFR < 30 mL/min/1.73m²) due to risk of electrolyte and fluid overload. For mild to moderate impairment (eGFR 30-89 mL/min/1.73m²), monitor serum potassium, calcium, phosphorus, and magnesium; reduce infusion rate as needed. |
| Liver impairment | Use with caution in hepatic impairment; no specific Child-Pugh based dosing. Monitor for signs of hyperammonemia and fluid overload. Avoid in severe hepatic encephalopathy. |
| Pediatric use | Weight-based dosing individualized per metabolic and fluid needs. Typical range: 20-40 mL/hr for neonates and infants, adjusted for age and condition. Maximum glucose infusion rate: 12-14 mg/kg/min for neonates. |
| Geriatric use | Use with caution; monitor renal function and fluid balance. Start at lower infusion rates (e.g., 50-75 mL/hr) and titrate slowly due to reduced renal clearance and higher risk of electrolyte disturbances. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER (CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER).
| Breastfeeding | Components (dextrose, electrolytes) are normally present in breast milk and considered compatible with breastfeeding. No M/P ratio available; risk to infant is low when maternal levels are maintained within physiological ranges. |
| Teratogenic Risk | No teratogenic risk attributed to components at therapeutic doses; dextrose and electrolytes are essential nutrients. Fetal risks are primarily from maternal metabolic disturbances (e.g., hyperglycemia, electrolyte imbalances) which may cause fetal macrosomia, neonatal hypoglycemia, or electrolyte abnormalities if improperly managed. No specific trimester risk increase identified beyond maternal condition. |
■ FDA Black Box Warning
Not for use in patients with severe renal impairment, anuria, or known hypersensitivity to any component. Risk of fluid overload, electrolyte imbalances, and hyperglycemia. Must be administered under medical supervision with monitoring of electrolytes, blood glucose, and acid-base status.
| Serious Effects |
["Hypersensitivity to any component","Clinically significant hyperglycemia","Severe renal impairment or anuria","Uncompensated heart failure","Pulmonary edema","Health status where intravenous fluid administration is contraindicated"]
| Precautions | Use caution in patients with renal insufficiency (risk of electrolyte abnormalities), hepatic impairment (risk of hyperammonemia), and diabetes mellitus (risk of hyperglycemia). Monitor for signs of phlebitis or extravasation. Avoid rapid infusion to prevent hyperglycemia and fluid overload. |
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| Fetal Monitoring | Monitor maternal serum glucose, electrolytes, renal function, and acid-base balance frequently. Fetal monitoring for growth and well-being if used for parenteral nutrition in pregnancy; assess for signs of fluid overload or electrolyte disturbances. |
| Fertility Effects | No direct adverse effects on fertility. Appropriate use corrects nutritional deficiencies that may improve fertility outcomes; however, underlying conditions requiring this product may affect fertility. |