CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER (CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER).
CLINIMIX 4.25/10 is a parenteral nutrition solution providing amino acids (4.25%) for protein synthesis and dextrose (10%) as a carbohydrate calorie source. The amino acids are used for tissue repair and growth, while dextrose provides energy via glycolysis and oxidative phosphorylation.
| Metabolism | Amino acids are metabolized via transamination, deamination, and urea cycle; dextrose is metabolized via glycolysis and the Krebs cycle under insulin regulation. Metabolism occurs primarily in the liver and peripheral tissues. |
| Excretion | Renal: 95-100% (as amino acids, glucose, and metabolites); minimal biliary/fecal elimination. |
| Half-life | Amino acids: 0.5-2 hours (individual amino acids vary); dextrose: 1-2 hours (insulin-dependent); terminal half-life not defined due to continuous infusion. |
| Protein binding | <5% (negligible binding to plasma proteins for amino acids and dextrose). |
| Volume of Distribution | Amino acids: 0.4-0.6 L/kg (total body water); dextrose: 0.2-0.3 L/kg (extracellular fluid initially, then equilibrates with total body water). |
| Bioavailability | Intravenous: 100% (only route of administration). |
| Onset of Action | Intravenous: Immediate (within minutes for nitrogen balance and blood glucose elevation). |
| Duration of Action | Intravenous: 4-6 hours after infusion cessation (metabolic effects persist until substrate depletion); clinical duration depends on infusion rate and patient metabolic demand. |
Intravenous infusion; typical adult dose is 500-2000 mL per day, providing 4.25 g/100 mL amino acids and 10 g/100 mL dextrose, infused at a rate not exceeding 100 mL/hour initially, adjusted based on metabolic and clinical response.
| Dosage form | INJECTABLE |
| Renal impairment | In GFR <50 mL/min, reduce total daily dose by 50%; if GFR <20 mL/min, avoid use or administer under close monitoring of serum electrolytes and fluid balance. |
| Liver impairment | In Child-Pugh Class B or C, reduce amino acid content by 50-75% and monitor for hyperammonemia; avoid in severe encephalopathy. |
| Pediatric use | Weight-based: 2-3 g amino acids/kg/day and 10-15 g dextrose/kg/day; typical infusion rate 0.5-1.0 mL/kg/hour, titrated to metabolic parameters. |
| Geriatric use | Start at lower end of adult dose (500-1000 mL/day) with infusion rate ≤50 mL/hour; monitor renal function and fluid balance closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER (CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER).
| Breastfeeding | Excretion into human milk is unknown. Since CLINIMIX is administered intravenously and contains nutrients normally present in breast milk, it is unlikely to pose a risk to the nursing infant. Caution is advised, and the decision to breastfeed should consider the mother's clinical need. M/P ratio not established. |
| Teratogenic Risk | CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% is a parenteral nutrition solution containing amino acids and dextrose. No specific teratogenic risk has been established; however, amino acid and dextrose solutions are generally considered essential for maternal and fetal nutrition when indicated. Use only if clearly needed, weighing potential benefits against unknown risks. No trimester-specific data available. |
■ FDA Black Box Warning
This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature and they require large amounts of calcium and phosphate solutions, which contain aluminum.
| Serious Effects |
["Hypersensitivity to any component","Severe metabolic acidosis","Hemochromatosis","Severe hyperglycemia or hyperosmolar coma","Uremia (without dialysis)","Anuria or severe renal failure","Liver failure (hepatic coma)","Inborn errors of amino acid metabolism"]
| Precautions | ["Monitor for signs of infection (catheter-related sepsis)","Risk of hyperglycemia, especially in diabetic patients; monitor blood glucose","Electrolyte imbalances and fluid overload","Aluminum toxicity with prolonged use in renal impairment","Hepatic steatosis with long-term use","Do not use if solution is discolored or contains particulate matter"] |
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| Fetal Monitoring | Monitor maternal serum electrolytes, blood glucose, fluid balance, and renal function during administration. Fetal monitoring is generally not required unless maternal complications (e.g., electrolyte imbalances, hyperglycemia) occur that could affect the fetus. |
| Fertility Effects | No data on effects on fertility. As a parenteral nutrition solution, it supplies essential nutrients and may support fertility in malnourished patients but adverse effects on fertility are not anticipated. |