TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER (TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER).
Amino acids serve as substrates for protein synthesis and intermediary metabolism; dextrose provides caloric replacement; electrolytes maintain acid-base and electrolyte balance.
| Metabolism | Amino acids are metabolized via deamination, transamination, and oxidation; dextrose undergoes glycolysis and oxidation; electrolytes are excreted renally. |
| Excretion | Amino acids: renal elimination of unmodified amino acids is minimal (<5%); most nitrogen is excreted as urea via kidneys. Dextrose: fully metabolized, negligible renal excretion of intact glucose. Electrolytes: renally excreted. |
| Half-life | Not applicable as a composite; amino acids have varying half-lives (minutes). Dextrose: glucose half-life ~1.5-2.5 hours in healthy individuals. Clinical context: continuous infusion maintains steady state. |
| Protein binding | Amino acids: negligible (<5%). Dextrose: none. Electrolytes: variable (e.g., calcium ~45% bound to albumin). |
| Volume of Distribution | Not a single Vd; amino acids distribute widely (0.5-2 L/kg). Dextrose Vd ~0.2 L/kg (total body water). Electrolytes: Vd corresponds to distribution spaces (e.g., sodium ≈0.25 L/kg). |
| Bioavailability | Intravenous: 100%. |
| Onset of Action | Intravenous: immediate infusion-dependent rise in plasma glucose and amino acid levels within minutes. |
| Duration of Action | Intravenous: duration is dependent on infusion rate; metabolic effects persist as long as infusion continues; glucose levels return to baseline within 30-60 minutes after cessation of low-rate infusion. |
Intravenous infusion; typical adult dose is 500 mL to 1000 mL per day administered as a continuous or intermittent infusion, providing 4.25% amino acids and 5% dextrose. Rate adjusted based on metabolic needs and tolerance.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR <50 mL/min: use with caution; may require reduction in volume and amino acid load to avoid fluid overload and accumulation of nitrogenous waste. For GFR <15 mL/min: avoid use or use only under strict monitoring with dose reduction of 50% or more. |
| Liver impairment | Child-Pugh Class A: no adjustment. Class B: reduce dose by 25-50% to avoid precipitating hepatic encephalopathy. Class C: avoid use or use minimal amounts with close monitoring. |
| Pediatric use | Weight-based: initial dose 0.5-1.0 g amino acids/kg/day (equivalent to 12-24 mL/kg/day of this solution) via intravenous infusion; titrate up to 2-3 g/kg/day based on tolerance and metabolic needs. |
| Geriatric use | Elderly patients may have reduced renal and hepatic function; begin at lower end of dosing range (e.g., 250-500 mL/day) and monitor for fluid overload, electrolyte disturbances, and azotemia; adjust based on clinical response and laboratory values. |
| 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 5% IN PLASTIC CONTAINER (TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER).
| Breastfeeding | No specific M/P ratio data available. Parenteral amino acids and dextrose are considered compatible with breastfeeding when administered as part of TPN, as they are normal blood constituents. However, caution should be exercised due to lack of specific safety data in lactating women. |
| Teratogenic Risk | Parenteral amino acids and dextrose are standard components of total parenteral nutrition (TPN). No teratogenic effects attributable to these components in standard doses have been reported. However, any underlying maternal condition requiring TPN may pose fetal risks. Use only if clearly needed in pregnancy. |
■ FDA Black Box Warning
Not for use in patients with severe lactic acidosis, hyperglycemic hyperosmolar state, or severe metabolic alkalosis. Risk of infections, sepsis, and metabolic complications from central line administration.
| Serious Effects |
["Severe lactic acidosis","Hyperglycemic hyperosmolar state","Severe metabolic alkalosis","Hypersensitivity to any component","Inborn errors of amino acid metabolism","Severe hepatic failure","Severe renal failure with azotemia"]
| Precautions | ["Risk of hyperglycemia","Hypoglycemia upon sudden discontinuation","Electrolyte imbalances","Fluid overload","Thrombophlebitis from peripheral administration","Hepatic steatosis with prolonged use"] |
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| Fetal Monitoring | Monitor maternal electrolytes, blood glucose, renal function, liver function, and acid-base balance. In fetus, consider growth assessment if TPN is prolonged. Adequate monitoring of maternal nutritional status is essential. |
| Fertility Effects | No direct effects on fertility known. However, correction of malnutrition via TPN may improve fertility in malnourished individuals. Underlying conditions requiring TPN may themselves impair fertility. |