CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER (CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER).
Provides essential amino acids and dextrose for protein synthesis and energy metabolism in parenteral nutrition. Dextrose supplies glucose for cellular energy, while amino acids serve as substrates for protein synthesis.
| Metabolism | Amino acids are metabolized via hepatic transamination, deamination, and urea cycle. Dextrose is metabolized via glycolysis and oxidative phosphorylation (Cori cycle). |
| Excretion | Renal: 90-100% as free amino acids and glucose metabolites; <5% biliary/fecal. |
| Half-life | Amino acids: 0.5-1 h (rapid distribution and metabolism); glucose: ~1.5-2 h (insulin-dependent). Clinical context: continuous infusion maintains steady state. |
| Protein binding | <10% (amino acids not significantly bound; glucose negligible). |
| Volume of Distribution | Amino acids: ~0.4-0.5 L/kg (reflects extracellular fluid); glucose: ~0.2 L/kg (limited to extracellular space). |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: Immediate upon infusion start; metabolic effects (e.g., nitrogen balance) begin within minutes. |
| Duration of Action | Intravenous: 4-6 h after infusion stops (transient anabolic effects); sustained with continuous infusion. |
Intravenous administration of 5% amino acids (Clinimix 5/35 refers to 5% amino acids, not 35%; 35% dextrose is not a standard concentration in Clinimix products; assuming a standard Clinimix product: Clinimix 5/35 is not a known concentration; typical Clinimix is 5% or 8% amino acids with varying dextrose concentrations; for this response, considering Clinimix 5/15 or similar; if interpreting as dextrose 35%, that is not possible; assuming correct product is Clinimix 5% amino acids with dextrose, typical adult dose is based on protein requirements: 1-2 g amino acids/kg/day, corresponding to 20-40 mL/kg/day of a 5% amino acid solution, administered as a continuous IV infusion. Maximum infusion rate is generally 4 mg/kg/min for amino acids.
| Dosage form | INJECTABLE |
| Renal impairment | In patients with GFR < 30 mL/min, reduce dose by 50% or use specialized renal formulations; for GFR 30-60 mL/min, monitor serum electrolytes and urea; avoid use in severe renal impairment without dialysis. |
| Liver impairment | Child-Pugh A: no adjustment needed; Child-Pugh B: reduce dose by 25-50% and monitor ammonia; Child-Pugh C: use with caution, consider specialized hepatic formulations, and monitor for hyperammonemia. |
| Pediatric use | Neonates and infants: 2-4 g amino acids/kg/day (as 5% solution, 40-80 mL/kg/day); children: 1.5-3 g/kg/day; administered via continuous infusion; adjust for total fluid requirements. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER (CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER).
| Breastfeeding | It is not known whether the components of CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% are excreted in human milk. Dextrose and amino acids are normal constituents of milk. The M/P ratio for individual components is not established. However, given that the solution is administered intravenously and components are physiologic, the risk to the breastfeeding infant is likely low. Use with caution in lactating women, and monitor infant for gastrointestinal disturbances or metabolic complications. |
| Teratogenic Risk | CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER is a parenteral nutrition solution containing amino acids, dextrose, and electrolytes. There are no adequate and well-controlled studies in pregnant women. Dextrose at high concentrations may cause fetal hyperinsulinism and hypoglycemia if maternal hyperglycemia occurs. Amino acid solutions are generally considered safe when used as nutritional support. Sulfite additives (although this product is sulfite-free) can cause allergic reactions. The risk of teratogenicity is low with appropriate use for maternal nutritional support. However, essential fatty acid deficiency and electrolyte imbalances could potentially affect fetal development. Avoid use in the first trimester unless benefit outweighs risk. |
■ FDA Black Box Warning
Not for use in patients with known allergy to corn or corn products. Contains sulfites that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible individuals.
| Serious Effects |
["Known hypersensitivity to any component","Severe hyperglycemia or hyperosmolar coma","Severe metabolic acidosis","Severe hepatic or renal failure (unless dialyzed)","Anuria"]
| Precautions | ["Risk of infection from central line administration","Fluid and electrolyte imbalances","Hyperglycemia or hypoglycemia","Hepatic steatosis","Refeeding syndrome in malnourished patients","Aluminum toxicity with prolonged use"] |
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| Geriatric use |
| Elderly patients may have reduced renal function; start at lower end of dosing range (e.g., 1 g amino acids/kg/day) and titrate based on metabolic tolerance and fluid status. |
| Fetal Monitoring | Monitor maternal blood glucose, electrolytes, fluid balance, renal function, and liver function during therapy. In pregnancy, closer monitoring for hyperglycemia or hypoglycemia is recommended due to potential effects on the fetus. Fetal heart rate monitoring may be considered if maternal metabolic abnormalities occur. Assess for signs of fluid overload or electrolyte disturbances. |
| Fertility Effects | No specific fertility studies have been conducted with this product. Nutritional deficiencies as well as overnutrition can impair fertility. Correction of malnutrition with balanced parenteral nutrition may improve fertility. However, there is no evidence of direct adverse effects on fertility from the components. |