TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER (TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER).
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% is a crystalline amino acid solution combined with electrolytes and dextrose. Amino acids provide substrates for protein synthesis, dextrose supplies calories to minimize protein catabolism, and electrolytes maintain acid-base and electrolyte balance.
| Metabolism | Amino acids are metabolized via transamination, deamination, and oxidation pathways; dextrose is metabolized via glycolysis and oxidative phosphorylation; electrolytes are excreted or reabsorbed as needed. |
| Excretion | Renal: >95% of infused amino acids and dextrose metabolites excreted as urea, CO2, and water. Biliary/fecal: negligible. |
| Half-life | Amino acids: 15-30 min (rapid redistribution). Dextrose: 1-2 h. Clinical context: continuous infusion maintains steady state. |
| Protein binding | <5% for amino acids; dextrose not protein-bound. |
| Volume of Distribution | Amino acids: 0.5-1 L/kg; dextrose: 0.2-0.3 L/kg. Reflects distribution into total body water and extracellular fluid. |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: immediate; clinical effect (nutritional support) within minutes of infusion start. |
| Duration of Action | Intravenous: sustained for duration of infusion; metabolic effects persist 1-2 h post-infusion. |
Intravenous infusion: 500-1000 mL administered over 1-2 hours per day, adjusted based on electrolyte and fluid requirements. Typical adult dose provides 2.75% amino acids and 5% dextrose with electrolytes.
| Dosage form | INJECTABLE |
| Renal impairment | Not applicable for fixed-combination product; use with caution in renal impairment. If GFR <30 mL/min, consider dose reduction or alternative therapy to avoid fluid overload and electrolyte imbalances. Monitor serum electrolytes and renal function closely. |
| Liver impairment | Contraindicated in severe hepatic encephalopathy. In Child-Pugh A/B: no specific dose adjustment; monitor ammonia levels and neurological status. Avoid in severe liver disease due to risk of worsening encephalopathy. |
| Pediatric use | Dose based on weight and fluid/electrolyte needs: 10-20 mL/kg/day (providing 0.275-0.55 g amino acids/kg/day and 0.5-1 g dextrose/kg/day). Titrate to clinical response and serum electrolytes. Not recommended in neonates due to electrolyte composition. |
| Geriatric use | Use with caution due to age-related decline in renal function. Initiate at lower end of dosing range (e.g., 500 mL over 2 hours) and monitor fluid status, electrolytes, and renal function. Consider reduced infusion rate to avoid volume overload. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER (TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER).
| Breastfeeding | It is not known whether this solution is excreted in human milk. Dextrose and electrolytes are normal constituents of human milk. The M/P ratio is not calculable due to lack of data. Caution should be exercised when administered to a nursing woman. Potential for infant hyperglycemia if excessive doses are given to the mother. |
| Teratogenic Risk | No adequate and well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Dextrose solutions may cause maternal and fetal hyperglycemia, which may be associated with fetal harm, including macrosomia, neonatal hypoglycemia, and congenital anomalies. The risk is dose-dependent and related to maternal glycemic control. Sulfite-free formulation reduces risk of allergic reactions. Use only if clearly needed with careful monitoring of maternal blood glucose. |
■ FDA Black Box Warning
This product contains sulfites that may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible individuals. Sulfite sensitivity is more frequent in asthmatic patients.
| Serious Effects |
Absolute: Hypersensitivity to any component, including sulfites; severe electrolyte or acid-base disturbances; fluid overload; anuria; severe hepatic impairment; uncontrolled hyperglycemia. Relative: Mild to moderate hepatic/renal impairment, heart failure, or electrolyte imbalances (monitor closely).
| Precautions | Use with caution in patients with fluid overload, electrolyte imbalances, hepatic or renal impairment, and metabolic disorders. Monitor serum electrolytes, blood glucose, and acid-base status. Risk of hyperglycemia, hyperosmolar syndrome, and allergic reactions (sulfite sensitivity). |
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| Fetal Monitoring | Monitor maternal blood glucose, electrolytes, fluid balance, and signs of hyperglycemia or fluid overload. Monitor fetal heart rate and growth if used for prolonged periods. In preterm or sick neonates, monitor blood glucose, serum electrolytes, and osmolality due to high dextrose concentration. |
| Fertility Effects | No studies on fertility impairment have been conducted. High-dose dextrose may affect hormonal regulation and ovulation in women with pre-existing diabetes or insulin resistance. Not expected to have a direct effect on fertility in otherwise healthy individuals. |