CLINIMIX E 5/35 SULFITE FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive 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 |
| Molecular Weight | Dextrose: 180.16 Da; amino acids vary (e.g., glycine 75 Da, leucine 131 Da); electrolytes: sodium 23 Da, potassium 39 Da, calcium 40 Da, magnesium 24 Da, chloride 35 Da, acetate 59 Da, phosphate 95 Da. |
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 | Contains dextrose, amino acids, and electrolytes which are essential nutrients; generally considered safe when administered for maternal nutritional support. No known teratogenicity in recommended doses. |
| 2nd trimester | Safe for maternal nutrition when clinically indicated. Monitor blood glucose and electrolyte levels. |
| 3rd trimester | Safe for maternal nutrition; avoid excessive dextrose infusion to prevent neonatal hypoglycemia. Monitor for fluid overload. |
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).
| Placental transfer | Dextrose, amino acids, and electrolytes freely cross placenta; no barrier. Transfer is physiological and dose-dependent. |
| Breastfeeding | Components are endogenous substances normally present in breast milk; administration to mother is compatible with breastfeeding. No adverse effects reported. Monitor infant for glucose intolerance if high dextrose doses used. |
| Lactation Rating | Safe |
| 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. |
| 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. |
■ 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 |
Severe hyperglycemiaHyperkalemiaHypercalcemiaPulmonary edemaAnuriaGalactosemiaHypersensitivity to any component
| 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. |
| Food/Dietary | No direct food interactions as this is an intravenous product. However, oral intake is typically restricted during TPN therapy. Patients receiving TPN may require monitoring of blood glucose and electrolytes if transitioning to oral feeds. Avoid concurrent administration of alcohol due to risk of hypoglycemia. |
| Clinical Pearls | This is a high-osmolality (850 mOsm/L) parenteral nutrition solution containing 35% dextrose, amino acids, and electrolytes including calcium. MUST be administered via central venous line to prevent thrombophlebitis. Contains sulfite (≤0.3 mEq/L) as sodium metabisulfite; contraindicated in patients with known sulfite hypersensitivity (e.g., asthmatics). The calcium concentration (approx 4.7 mEq/L) is low; monitor ionized calcium in critically ill patients. Do not add phosphate to this solution as it may precipitate calcium phosphate. Use within 24 hours of spiking the bag; discard any unused portion. Incompatible with lipid emulsions; administer separately via Y-site with compatible fluids. |
| Patient Advice | This medication is a total parenteral nutrition (TPN) solution that provides complete nutrition intravenously. · It contains dextrose (sugar), amino acids (protein), electrolytes, calcium, and sulfites. · Notify your nurse immediately if you experience difficulty breathing, rash, itching, or swelling, especially if you have asthma or sulfite allergy. · You will need a special central venous catheter (large IV in chest or neck) to receive this solution. · Do not eat or drink anything unless instructed; this solution replaces oral nutrition. · Tell your doctor if you have diabetes, kidney problems, or fluid/electrolyte imbalances. |
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