CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive 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. |
| Molecular Weight | Dextrose 180.16 Da; amino acids vary (e.g., leucine 131.17 Da, lysine 146.19 Da) |
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. |
| 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. |
| 1st trimester | Limited data; use only if clearly needed. Parenteral nutrition may be necessary in severe cases of maternal malnutrition or hyperemesis gravidarum. |
| 2nd trimester | Limited data; use if benefits outweigh risks. Monitor maternal glucose and electrolytes. |
| 3rd trimester | Limited data; use if benefits outweigh risks. Monitor maternal and fetal growth, glucose, and electrolytes. |
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).
| Placental transfer | Amino acids and dextrose cross the placenta; transfer is concentration-dependent and regulated by placental transporters. |
| Breastfeeding | Clinimix 5/35 is a parenteral nutrition solution. Amino acids and dextrose are normal constituents of breast milk. Use only if clearly needed, with monitoring of infant for potential adverse effects such as hyperglycemia or electrolyte imbalance. |
| Lactation Rating | L3 (Moderately Safe) |
| 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. |
| 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. |
■ 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 |
Hypersensitivity to any componentSevere hyperglycemiaSevere electrolyte abnormalitiesSevere hepatic insufficiencySevere uremiaInborn errors of amino acid metabolismPulmonary edemaIntracranial hemorrhage (neonates)
| 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 |
| Food/Dietary | No direct food interactions as this is a parenteral nutrition product. However, concurrent oral intake may require adjustment to avoid overfeeding. Patients on this therapy often receive little or no oral nutrition; thus, any oral intake must be coordinated with the clinical team to prevent electrolyte imbalances or refeeding syndrome. |
| Clinical Pearls | CLINIMIX 5/35 is a dual-chamber bag containing 5% amino acids and 35% dextrose with electrolytes, but without sulfite. It provides approximately 1.45 kcal/mL (including calories from amino acids and dextrose). Contains no lipids, so must be supplemented with intravenous fat emulsion to prevent essential fatty acid deficiency. Solution is hypertonic (approx. 1500 mOsm/L) and requires central venous administration. Monitor serum electrolytes, glucose, and renal function. Do not use if patient has severe hyperglycemia, hyperkalemia, or metabolic acidosis. |
| Patient Advice | This medication provides nutrition through a central vein and will be given by a healthcare professional. · Report any signs of infection at the IV site, such as redness, swelling, or pain. · Tell your doctor if you have diabetes, as blood sugar may need monitoring. · Do not consume oral food or fluids unless advised by your healthcare team. · Inform your doctor of all medications you are taking, especially diuretics or insulin. |
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