TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER (TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER).
This combination product provides parenteral nutrition. Dextrose supplies calories and energy. Electrolytes (sodium, potassium, magnesium, calcium, chloride, acetate) maintain fluid and electrolyte balance. Amino acids provide nitrogen for protein synthesis.
| Metabolism | Dextrose is metabolized via glycolysis and oxidative phosphorylation. Amino acids undergo hepatic metabolism. Electrolytes are excreted renally. |
| Excretion | Renal: >95% as unchanged amino acids, dextrose (metabolized to CO2 and water), and electrolytes. Fecal/biliary: negligible (<1%). |
| Half-life | Not applicable as a single entity; components have independent kinetics: amino acids ~0.5-2 h (endogenous turnover), dextrose ~2 h (glucose), electrolytes follow renal clearance. |
| Protein binding | Minimal (<5%) for amino acids and dextrose; electrolytes largely unbound. |
| Volume of Distribution | 0.2-0.3 L/kg for glucose; amino acids distribute similarly to total body water (0.5-0.7 L/kg); electrolytes vary (e.g., Na+ 0.2-0.4 L/kg). |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: immediate upon infusion; provides calories and amino acids as soon as infused. |
| Duration of Action | Intravenous: 4-6 h for metabolic effects (glucose elevation, amino acid provision); clinical effects persist as long as infusion continues. |
Intravenous infusion: 500 mL to 2 L per day, typically at 42 mL/hour, providing 4.25% amino acids and 10% dextrose for parenteral nutrition.
| Dosage form | INJECTABLE |
| Renal impairment | GFR <50 mL/min: reduce total fluid and electrolyte content; monitor serum electrolytes and avoid excessive phosphate and potassium. GFR <30 mL/min: use with caution; may require specialized renal replacement formula. No specific dose reduction for amino acids, but volume adjustment needed. |
| Liver impairment | Child-Pugh B or C: reduce amino acid content; consider specialized hepatic formulation. Monitor for hyperammonemia. Use with caution due to reduced clearance of amino acids. |
| Pediatric use | Initial dose: 0.5-1 g/kg/day amino acids (11.8-23.5 mL/kg/day of this solution) and 2.5-5 g/kg/day dextrose; increase gradually. Typical infusion rate: 0.1-0.2 mL/kg/hour initially, advancing as tolerated. Monitor for hyperglycemia and electrolyte imbalances. |
| Geriatric use | Start at lower end of adult dose: 500 mL/day; monitor for fluid overload and hyperglycemia. Adjust electrolytes based on renal function. Use with caution due to altered body composition and reduced renal reserve. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER (TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER).
| Breastfeeding | Safety in breastfeeding is unknown. Dextrose and amino acids are normal constituents of breast milk; intravenous administration may increase maternal serum levels and transfer into milk. M/P ratio not available. Caution advised, consider risk/benefit. |
| Teratogenic Risk | TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% is a parenteral nutrition solution. Dextrose and amino acids in standard doses are not associated with teratogenicity. However, caution is warranted due to possible electrolyte imbalances and hyperglycemia, which may affect fetal development (e.g., macrosomia, congenital anomalies with poor glycemic control). There are no adequate studies in pregnant women; use only if clearly needed. Trimesters: First trimester - low risk, but hyperglycemia may be teratogenic; second and third trimesters - risk of fetal hyperinsulinemia, hypoglycemia, and electrolyte disturbances. |
■ FDA Black Box Warning
Not for use in patients with known hypersensitivity to any component. Contains sulfites (may cause allergic reactions including anaphylaxis) though labeled 'sulfite-free'? Verify formulation. For sulfite-free formulation, no sulfite warning.
| Serious Effects |
["Hypersensitivity to any component","Severe hyperglycemia","Severe electrolyte disorders","Pulmonary edema","Renal failure with anuria"]
| Precautions | ["Fluid overload","Electrolyte imbalances","Hyperglycemia","Metabolic acidosis","Phlebitis","Infection risk"] |
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| Fetal Monitoring | Monitor maternal blood glucose, serum electrolytes, renal function, and liver function. Monitor fetal growth and well-being via ultrasound and non-stress tests if prolonged use in pregnancy. |
| Fertility Effects | No known adverse effects on fertility. Malnutrition correction may improve fertility in malnourished women. |