CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER (CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER).
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER is a parenteral nutrition solution. Dextrose provides caloric energy via glycolysis and oxidative phosphorylation. Amino acids (4.25%) serve as substrates for protein synthesis, gluconeogenesis, and metabolic pathways. Electrolytes maintain osmotic balance and cellular function.
| Metabolism | Dextrose is metabolized via glycolysis and the Krebs cycle. Amino acids undergo deamination and transamination in the liver, with carbon skeletons entering gluconeogenesis or the TCA cycle. Electrolytes are excreted renally or used in buffer systems. |
| Excretion | Renal: ~95% as unchanged glucose and amino acids; minimal biliary/fecal. |
| Half-life | Not applicable as a fixed formulation; individual components: glucose ~2-4 h, amino acids ~0.5-2 h depending on type. |
| Protein binding | Negligible (<5%) for amino acids and glucose; no significant protein binding. |
| Volume of Distribution | Glucose: ~0.2 L/kg; amino acids: variable (0.2-0.5 L/kg); corresponds to extracellular fluid volume. |
| Bioavailability | Intravenous: 100% (administered directly into bloodstream). |
| Onset of Action | Intravenous: immediate (within minutes) for caloric and amino acid provision. |
| Duration of Action | Intravenous: sustained as long as infusion continues; metabolic effects last for hours after cessation. |
Intravenous infusion: 4.25% amino acids with 20% dextrose. Typical adult dose: 1-2 L per day via central line, infused at a rate of 50-100 mL/hour, adjusted based on metabolic needs and tolerance.
| Dosage form | INJECTABLE |
| Renal impairment | In acute kidney injury or GFR < 30 mL/min, reduce amino acid dose to 0.6-0.8 g/kg/day and monitor serum electrolytes; may require lower volume to avoid fluid overload. Use with caution. No specific GFR-based dosing available. |
| Liver impairment | For Child-Pugh class B or C: reduce amino acid dose to 0.8-1.0 g/kg/day; avoid in severe hepatic encephalopathy. Use branched-chain amino acid-enriched formulations if indicated. Monitor ammonia levels. |
| Pediatric use | Weight-based: Amino acids 1.5-3 g/kg/day, dextrose starting at 10-15 mg/kg/min, adjusted for age and condition. Infuse via central line. For neonates, use specialized formulations. Titrate to blood glucose and tolerance. |
| Geriatric use | Start at lower end of adult dose, monitor volume status due to risk of fluid overload and electrolyte disturbances. Consider renal function (often decreased) and adjust accordingly. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER (CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER).
| Breastfeeding | M/P ratio not available. Amino acids and dextrose are endogenous nutrients; excretion into breast milk is minimal and not clinically significant. Compatible with breastfeeding. |
| Teratogenic Risk | No known teratogenic risk. Total parenteral nutrition (TPN) with amino acids and dextrose is considered safe in pregnancy if maternal nutritional deficiencies are corrected. No trimester-specific risks identified in standard references. |
■ FDA Black Box Warning
Not for use in patients with a history of hypersensitivity to any component. High-risk for infections due to catheter-related sepsis. Monitor for signs of air embolism. Do not use if precipitate or cloudiness is present.
| Serious Effects |
Absolute: Hypersensitivity to any component, severe hyperglycemia, uncontrolled metabolic acidosis, severe fluid overload, anuria, and conditions requiring dialysis. Relative: Hepatic failure, phenylketonuria (if containing phenylalanine), and concurrent use of certain medications affecting electrolyte balance.
| Precautions | Risk of hyperglycemia, fluid overload, electrolyte imbalances, hepatic steatosis, and refeeding syndrome. Monitor blood glucose, electrolytes, liver function, and fluid balance. Use with caution in renal impairment, metabolic acidosis, and patients with hypersensitivity to sulfites (though sulfite-free formulation minimizes this risk). |
| Food/Dietary | No oral food or drink should be consumed concurrently unless clinically indicated, as CLINIMIX replaces all oral intake. Enteral feeding interactions are not applicable. Dextrose content may affect blood glucose; adjust insulin as needed. |
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| Fetal Monitoring |
| Monitor maternal electrolytes, blood glucose, renal and hepatic function, and fluid balance. Fetal monitoring for growth and well-being is recommended in pregnant patients requiring TPN. |
| Fertility Effects | No known adverse effects on fertility. TPN may improve fertility in malnourished women by restoring nutritional status. |
| Clinical Pearls | CLINIMIX 4.25/20 is a parenteral nutrition solution containing 4.25% amino acids and 20% dextrose. It is sulfite-free, reducing risk of allergic reactions in sulfite-sensitive patients. Use a dedicated central line for administration due to high osmolarity (~1350 mOsm/L). Monitor serum glucose, electrolytes, and liver function tests closely. Do not administer peripherally. Incompatible with fat emulsions in same container; use Y-site with caution. Assess for signs of hyperglycemia, hyperosmolar state, or refeeding syndrome. |
| Patient Advice | This medication is given through a central vein, not into a peripheral vein. · You may need frequent blood tests to check blood sugar, electrolytes, and liver function. · Report any signs of infection, such as redness, swelling, or pain at the IV site. · Do not eat or drink anything unless instructed by your healthcare provider, as this formula provides complete nutrition. · Tell your doctor if you have a history of sulfite allergy, though this product is sulfite-free. · Notify your healthcare team immediately if you experience headache, nausea, weakness, or confusion. |