CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER (CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER).
Parenteral nutrition formulation providing amino acids (synthetic crystalline L-amino acids), dextrose (carbohydrate calories), and electrolytes. Amino acids support protein synthesis and nitrogen balance; dextrose provides calories to prevent catabolism.
| Metabolism | Amino acids undergo hepatic metabolism (transamination, deamination, urea cycle); dextrose undergoes cellular glycolysis and subsequent metabolism via Krebs cycle; electrolytes are distributed and excreted renally. |
| Excretion | Renal (primarily as urea, glucose, electrolytes); >90% of infused nitrogen excreted as urea in urine; glucose is metabolized or excreted renally if hyperglycemic; electrolytes follow renal excretion. |
| Half-life | Not applicable as a fixed drug; the components have varying half-lives: amino acids ~1-2 hours, dextrose ~1-2 hours, electrolytes follow physiological kinetics. |
| Protein binding | Negligible for amino acids and dextrose; electrolytes have variable binding (e.g., calcium ~40% bound to albumin). |
| Volume of Distribution | Not applicable as a combination product; individual components distribute into total body water (0.6 L/kg) for amino acids and dextrose; electrolytes Vd varies (e.g., sodium ~0.6 L/kg, potassium ~4 L/kg). |
| Bioavailability | Intravenous: 100% bioavailable; not administered via other routes. |
| Onset of Action | Intravenous: immediate upon infusion for nutritional support; metabolic effects (e.g., nitrogen balance) occur within 24-48 hours of continuous infusion. |
| Duration of Action | Duration depends on infusion rate and metabolic utilization; continuous infusion provides sustained nutritional support; effects on nitrogen balance last as long as infusion continues. |
Intravenous use only. Typical adult dose for maintenance or replacement is 1 to 2 L per day, administered via central or peripheral vein. Contains dextrose 20% with 5% amino acids representing 170 kcal/L from dextrose and 40 g protein/L. Rate of infusion depends on metabolic and clinical needs, generally not to exceed 4 mg/kg/min dextrose.
| Dosage form | INJECTABLE |
| Renal impairment | Dose adjustments based on GFR: For GFR 10-50 mL/min, reduce protein intake (amino acids) to 0.6-0.8 g/kg/day; for GFR <10 mL/min, restrict to 0.6 g/kg/day or consider essential amino acid formulas. Monitor electrolytes and avoid volume overload. |
| Liver impairment | Child-Pugh Class A: No adjustment needed; Class B: Reduce protein to 0.5-0.7 g/kg/day; Class C: Restrict to 0.5 g/kg/day or less, use branched-chain amino acid formulas if encephalopathy present. |
| Pediatric use | Individualized: Typical protein requirement 1.5-3 g/kg/day and dextrose infusion rate 5-15 mg/kg/min. Start at 0.5-1 g/kg/day protein and increase as tolerated; dextrose 5-10 mg/kg/min initially. Monitor fluid balance and electrolytes closely. |
| Geriatric use | Elderly patients often have reduced renal and hepatic function. Start at lower end of adult dosing (e.g., 1 L/day). Monitor glucose tolerance, fluid balance, and renal function closely. Adjust protein and dextrose content based on individual metabolic needs and comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER (CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER).
| Breastfeeding | Dextrose and amino acids are normal constituents of human milk. No specific M/P ratio is available; systemic levels from parenteral nutrition are not expected to significantly alter milk composition. Use is considered compatible with breastfeeding when clinically indicated. |
| Teratogenic Risk | Nutritional supplementation at clinically recommended doses is not associated with teratogenicity. Dextrose and amino acids are essential nutrients; no fetal risks are expected when used as indicated. However, hyperglycemia or electrolyte imbalances from improper use may pose fetal risks, particularly during organogenesis (1st trimester) and later trimesters (risk of macrosomia, neonatal hypoglycemia). |
■ FDA Black Box Warning
WARNING: DEATH FROM CENTRAL LINE INFECTION. CLINIMIX must be administered via central venous catheter with strict aseptic technique. Improper catheter care or contamination can lead to fatal sepsis.
| Serious Effects |
["Absolute: Known hypersensitivity to any component (amino acids, dextrose, or electrolytes).","Absolute: Inborn errors of amino acid metabolism (e.g., maple syrup urine disease, phenylketonuria).","Absolute: Severe hyperglycemia or diabetic ketoacidosis (unless insulin co-administered and monitored).","Relative: Severe hepatic impairment (may require amino acid profile adjustment; consult specialist).","Relative: Severe renal failure (may cause fluid/electrolyte overload; consider specialized formulation)."]
| Precautions | ["Central line-associated bloodstream infections (CLABSI): Use strict aseptic technique, monitor catheter site, and replace tubing per protocol.","Hyperglycemia: Risk due to dextrose load; monitor blood glucose and administer insulin as needed.","Refeeding syndrome: Initiate slowly in severely malnourished patients to avoid fluid/electrolyte shifts.","Fluid overload: Monitor volume status, especially in patients with cardiac or renal impairment.","Electrolyte imbalances: Regularly monitor serum electrolytes, magnesium, phosphate.","Aluminum toxicity: Contains aluminum (≤25 mcg/L); risk in renal impairment, preterm infants."] |
Loading safety data…
| Fetal Monitoring | Monitor maternal serum glucose, electrolytes (sodium, potassium, calcium, magnesium, phosphate), acid-base status, renal function, and fluid balance. In pregnancy, additional monitoring of maternal blood pressure, fetal growth (ultrasound), and fetal heart rate may be warranted if prolonged parenteral nutrition is used. |
| Fertility Effects | No known adverse effects on fertility from standard parenteral nutrition. Correction of maternal nutritional deficiencies may improve fertility outcomes. |
| Food/Dietary | N/A (parenteral nutrition; no food interactions) |
| Clinical Pearls | CLINIMIX 5/20 SULFITE FREE IN DEXTROX 20% is a parenteral nutrition solution containing 5% amino acids and 20% dextrose. It does not contain sulfites, which is important for patients with sulfite sensitivity. Use only if the solution is clear and the container is undamaged. Do not add supplements without verifying compatibility. Monitor serum electrolytes, blood glucose, liver function, and fluid status closely. This is a hypertonic solution and must be administered via central line to avoid thrombophlebitis. |
| Patient Advice | This medication provides complete nutrition through an IV line and should be used exactly as prescribed. · Do not use if the solution is discolored or contains particles. · Report any signs of infection at the IV site, such as redness, swelling, or warmth. · You may need regular blood tests to monitor your glucose, electrolyte, and liver function. · Inform your healthcare provider if you have diabetes, sulfite allergy, or kidney problems. |