CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER (CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER).
Provides essential amino acids and dextrose for parenteral nutrition, supporting protein synthesis and energy metabolism.
| Metabolism | Amino acids metabolized via transamination and deamination pathways; dextrose metabolized via glycolysis and citric acid cycle. |
| Excretion | Renal excretion of urea and other nitrogenous waste products; no biliary or fecal elimination of nutrients. |
| Half-life | Not applicable as individual components (amino acids, dextrose, electrolytes) are not eliminated via first-order kinetics; amino acids have a plasma half-life of minutes to hours depending on metabolic demand and renal function. |
| Protein binding | Amino acids: negligible protein binding (<10%); dextrose: negligible; electrolytes: variable (e.g., calcium ~40% bound to albumin). |
| Volume of Distribution | Amino acids: 0.5-1.0 L/kg (distributes to total body water); dextrose: 0.2 L/kg (primarily extracellular); electrolytes: variable (e.g., sodium 0.6 L/kg, potassium 4 L/kg). |
| Bioavailability | Intravenous: 100% (complete bioavailability). |
| Onset of Action | Intravenous: immediate upon infusion; metabolic effects (e.g., nitrogen retention, blood glucose elevation) begin within 30 minutes. |
| Duration of Action | Duration is dependent on infusion rate and metabolic clearance; continuous infusion provides sustained nutritional support; post-infusion effects last until nutrients are metabolized (4-6 hours for amino acids, 2-4 hours for dextrose). |
Intravenous infusion. Dose individualized based on metabolic requirements, energy expenditure, and clinical status. Typical adult dose: 500 mL to 1000 mL per day, providing 8% amino acids and 14% dextrose, infused at a rate not exceeding 0.1 g/kg/hr of amino acids and 0.5 g/kg/hr of dextrose.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in patients with severe renal impairment (eGFR <30 mL/min/1.73 m²) requiring dialysis. For mild to moderate impairment (eGFR 30–89 mL/min/1.73 m²), reduce dose by 50% and monitor serum electrolytes and BUN. |
| Liver impairment | Use with caution in hepatic insufficiency. For Child-Pugh Class B or C, reduce dose by 50% and monitor ammonia levels. Avoid use in patients with hepatic encephalopathy. |
| Pediatric use | Weight-based dosing: For children, initial dose 0.5–1 g/kg/day of amino acids and 5–10 g/kg/day of dextrose, titrated to metabolic needs. Infusion rate should not exceed 0.1 g/kg/hr of amino acids. |
| Geriatric use | No specific dosage adjustment recommended, but start at lower end of dosing range due to age-related decline in renal function and comorbidities. Monitor fluid and electrolyte status closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER (CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% IN PLASTIC CONTAINER).
| Breastfeeding | It is not known whether components of CLINIMIX 8/14 (amino acids, dextrose, electrolytes) are excreted in human milk. Dextrose and amino acids are normal constituents of breast milk. The M/P ratio is not available. Caution is advised when administered to a nursing woman, as the impact on the nursing infant is unknown. The benefit of breastfeeding should be weighed against the potential risk. |
| Teratogenic Risk | CLINIMIX 8/14 SULFITE FREE IN DEXTROSE 14% in plastic container is a parenteral nutrition solution containing amino acids, dextrose, and electrolytes. There are no adequate and well-controlled studies in pregnant women. Amino acids and dextrose are endogenous substances and are not known to be teratogenic at therapeutic doses. However, electrolyte imbalances or hyperglycemia resulting from administration could potentially affect fetal development. The risk is considered low with appropriate monitoring and dose adjustment. |
■ FDA Black Box Warning
Not for intravenous administration directly; must be used as part of total parenteral nutrition with appropriate additives. Risk of metabolic acidosis, hyperglycemia, and refeeding syndrome.
| Serious Effects |
["Severe metabolic acidosis","Hyperglycemia uncontrolled","Hepatic failure","Known hypersensitivity to any component"]
| Precautions | ["Monitor serum electrolytes, glucose, and acid-base balance","Risk of hyperglycemia, especially in diabetic patients","Possible electrolyte disturbances","Risk of infection from catheter use"] |
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| Fetal Monitoring | Monitor maternal vital signs, fluid balance, serum electrolytes (sodium, potassium, chloride, calcium, phosphorus, magnesium), blood glucose, serum urea nitrogen, creatinine, liver function tests, and acid-base status. Monitor fetal heart rate and uterine activity if indicated. Adjust infusion rate to avoid hyperglycemia, fluid overload, or electrolyte disturbances. Monitor for signs of infection or phlebitis at the infusion site. |
| Fertility Effects | No reproductive toxicity studies have been conducted with CLINIMIX 8/14. There is no evidence that amino acids, dextrose, or electrolytes at therapeutic doses affect fertility. However, underlying metabolic or nutritional disorders may impact fertility. No specific effects on fertility have been reported. |