CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER (CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER).
Provides essential amino acids and dextrose for parenteral nutrition; amino acids serve as substrates for protein synthesis, and dextrose supplies caloric energy to prevent catabolism and promote anabolism.
| Metabolism | Amino acids undergo hepatic metabolism via transamination, deamination, and urea cycle; dextrose is metabolized via glycolysis and oxidative phosphorylation. |
| Excretion | Renal: >95% as free amino acids and dextrose metabolites. Biliary/fecal: <5%. |
| Half-life | Amino acids: 4-6 hours; dextrose: 2-3 hours. Clinically, infusion rate clearance is rapid, with sustained effect only during continuous administration. |
| Protein binding | Negligible (<5%) for amino acids and dextrose; no specific binding proteins. |
| Volume of Distribution | Amino acids: 0.5-1.0 L/kg; dextrose: 0.2-0.4 L/kg. Represents distribution into total body water and extracellular fluid. |
| Bioavailability | Intravenous: 100% (only route of administration). |
| Onset of Action | Intravenous: immediate (minutes) for caloric availability based on infusion rate. |
| Duration of Action | Duration depends on infusion: as long as continuous IV is administered (parenteral nutrition). Typically 24-hour infusion cycles. |
Intravenous administration as a source of calories and amino acids. Typical adult dose: 500-1000 mL per day, infused at a rate determined by the patient's metabolic needs and clinical condition. Rate not to exceed 100 mL/hour initially.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR < 30 mL/min, reduce to 500 mL/day and monitor electrolytes and BUN closely. For GFR 30-60 mL/min, usual dose with monitoring. For GFR > 60 mL/min, no adjustment required. |
| Liver impairment | Child-Pugh Class A: usual dose; Class B: reduce dose by 50% and monitor ammonia; Class C: avoid use or reduce to minimum rate with close monitoring. |
| Pediatric use | Weight-based dosing: 100-200 mL/kg/day, not to exceed 2000 mL/day. Infusion rate: 5-10 mL/kg/hour, adjusted based on glucose tolerance and hydration status. |
| Geriatric use | Start at lower end of adult dose (500 mL/day) with slower infusion rate (50-80 mL/hour). Monitor renal function and electrolyte balance due to potential comorbidities and reduced renal reserve. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER (CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER).
| Breastfeeding | Not known if components (dextrose, amino acids, electrolytes) are excreted in human milk. Dextrose is a normal constituent of milk. M/P ratio not available. Likely compatible with breastfeeding if maternal glucose and electrolyte levels are normal; use caution in hyperglycemic or electrolyte-imbalanced mothers. |
| Teratogenic Risk | CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% is a parenteral nutrition solution. No adequate and well-controlled studies in pregnant women. Dextrose at high doses may cause fetal hyperglycemia and hyperinsulinemia, leading to neonatal hypoglycemia. Amino acids and electrolytes are essential nutrients; however, excess or imbalance may be harmful. General risk: use only if clearly needed; avoid hyperglycemia. |
■ FDA Black Box Warning
Not for intravenous administration to patients with hypersensitivity to any component; contains aluminum that may be toxic with prolonged use in patients with renal impairment or preterm infants.
| Serious Effects |
["Hypersensitivity to any component","Severe renal impairment without dialysis","Severe hepatic failure","Hyperglycemia","Acute myocardial infarction or stroke","Inborn errors of amino acid metabolism"]
| Precautions | ["Risk of pulmonary embolism due to precipitates in IV sets","Fluid/electrolyte imbalances","Hyperglycemia","Aluminum toxicity with prolonged use","Infectious complications from catheter use","Need for frequent monitoring of serum electrolytes, blood glucose, and acid-base balance"] |
Loading safety data…
| Fetal Monitoring | Monitor maternal blood glucose, electrolytes (Na, K, Ca, Mg, phosphate), renal function, liver function, acid-base status, and fluid balance. Fetal monitoring may include growth scans if prolonged nutritional support is required. |
| Fertility Effects | No specific data on fertility effects. Appropriate nutrition supports normal reproductive function; however, imbalances may affect fertility. Not intended for direct fertility treatment. |