CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER (CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER).
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% is a parenteral nutrition solution providing amino acids (5%) and dextrose (25%) for caloric and protein requirements. Amino acids serve as substrates for protein synthesis and other metabolic processes; dextrose provides calories to spare protein catabolism. No single molecular target.
| Metabolism | Dextrose undergoes glycolysis and enters the Krebs cycle; amino acids are metabolized via transamination, deamination, and incorporation into proteins. No specific enzyme induction or inhibition known. |
| Excretion | Renal elimination of amino acids and dextrose metabolites; virtually 100% renal excretion of dextrose metabolites (e.g., CO2) and amino acid nitrogen (as urea), with <2% biliary/fecal. |
| Half-life | Not applicable as a metabolic substrate; terminal half-life of dextrose is ~2 hours for glucose clearance; amino acids have variable half-lives of 0.3–2.5 hours based on individual amino acid metabolism and utilization. |
| Protein binding | Minimal for dextrose and amino acids; individual amino acids may bind to plasma proteins (e.g., tryptophan ~80-90% bound to albumin) but overall protein binding <5% for total mixture. |
| Volume of Distribution | Distributes primarily to extracellular fluid (0.2–0.3 L/kg) for dextrose; individual amino acids vary (e.g., glutamine Vd ~0.2 L/kg, branched-chain amino acids ~0.3 L/kg). |
| Bioavailability | Not applicable via oral route; intravenous administration yields 100% bioavailability. |
| Onset of Action | Intravenous: Immediate increase in plasma glucose and amino acid levels upon infusion initiation; full metabolic effect within 15–30 minutes. |
| Duration of Action | Duration of action is dependent on infusion rate and metabolic demand; continuous infusion provides sustained effect; glucose clearance occurs within 1–2 hours after infusion cessation. |
Intravenous infusion. Dose is individualized based on protein and calorie requirements. For adults, typical amino acid dose is 0.8-1.5 g/kg/day, with dextrose providing 25% concentration. Rate adjusted to meet metabolic needs, usually 1-2 mL/kg/hour.
| Dosage form | INJECTABLE |
| Renal impairment | In chronic kidney disease (GFR <30 mL/min), limit protein to 0.6-0.8 g/kg/day unless on dialysis. Monitor electrolytes. For acute kidney injury, consider protein restriction or increase based on renal replacement therapy. |
| Liver impairment | In decompensated cirrhosis (Child-Pugh C), reduce protein to 0.6-0.8 g/kg/day to avoid encephalopathy. Use branched-chain amino acid-enriched formulas if indicated. In mild-moderate disease, standard dosing may be tolerated. |
| Pediatric use | Weight-based: 0.5-3 g/kg/day of amino acids, with dextrose infusion rate starting at 4-8 mg/kg/min for preterm infants, up to 10-15 mg/kg/min for older children. Adjust for fluid and energy needs. Use age-appropriate concentrations. |
| Geriatric use | Start at lower end of dosing range (e.g., 0.8-1.2 g/kg/day amino acids). Monitor fluid status and renal function. Reduce rate if renal impairment present. May require lower dextrose load due to glucose intolerance. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER (CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER).
| Breastfeeding | Compatible with breastfeeding; M/P ratio not established. Monitor infant for hyperglycemia if maternal glucose elevated. |
| Teratogenic Risk | No teratogenic risk documented at recommended doses; dextrose and amino acids are essential nutrients. Avoid in severe acidosis or hyperglycemia. |
| Fetal Monitoring |
■ FDA Black Box Warning
Not for intravenous administration unless dilution is performed; death may result from administration of concentrated dextrose solutions. Contains aluminum that may be toxic with impaired renal function. Do not administer if solution is discolored or contains precipitate.
| Serious Effects |
["Hypersensitivity to any component","Severe hyperglycemia","Severe electrolyte/acid-base disorders","Hepatic coma","Anuria or severe renal impairment without dialysis","Uncorrected hypokalemia or hypophosphatemia"]
| Precautions | ["Risk of hyperglycemia, hyperosmolar syndrome, and metabolic acidosis","Electrolyte imbalances requiring monitoring","Fluid overload in renal/cardiac impairment","Aluminum toxicity in renal impairment","Infection risk from central line access","Do not administer intravenously without appropriate dilution"] |
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| Monitor maternal blood glucose, electrolytes, acid-base status, fluid balance, and weight gain. Fetal monitoring for growth and well-being per standard obstetrical care. |
| Fertility Effects | No known adverse effects on fertility at recommended doses. |