TRAVASOL 8.5% W/O ELECTROLYTES
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVASOL 8.5% W/O ELECTROLYTES (TRAVASOL 8.5% W/O ELECTROLYTES).
TRAVASOL 8.5% W/O ELECTROLYTES provides amino acids for protein synthesis, serving as a source of nitrogen and essential amino acids to support anabolism and prevent catabolism in patients unable to tolerate oral or enteral nutrition.
| Metabolism | Amino acids are metabolized via transamination, deamination, and urea cycle pathways in the liver and other tissues; excess amino acids are oxidized for energy or converted to glucose or fat. |
| Excretion | Primarily eliminated via metabolic pathways (hepatic deamination and transamination) with nitrogenous waste excreted renally as urea; negligible biliary/fecal excretion of unchanged amino acids. |
| Half-life | Not applicable as a single value; amino acids have variable half-lives (minutes to hours) depending on individual metabolic demand and plasma concentration; continuous infusion achieves steady state rapidly. |
| Protein binding | Minimal to no protein binding; amino acids circulate freely or as small peptides. |
| Volume of Distribution | Variable; individual amino acids distribute based on polarity and transport; total Vd approximates total body water (~0.6 L/kg) for most amino acids; clinical meaning reflects rapid equilibration with extracellular and intracellular spaces. |
| Bioavailability | Intravenous: 100% (not applicable to oral due to first-pass metabolism); product not formulated for other routes. |
| Onset of Action | Intravenous infusion: immediate (within minutes) elevation of plasma amino acid levels; clinical effect (nitrogen balance improvement) seen within 24-48 hours of continuous administration. |
| Duration of Action | Intravenous infusion: duration is dependent on infusion rate and metabolic utilization; effects wane within hours after discontinuation; continuous infusion required to maintain positive nitrogen balance. |
Intravenous infusion; 500 mL to 1 L per day, administered at a rate of 100-200 mL/hour. Dosage depends on protein and calorie requirements, typically 0.8-1.5 g/kg/day of amino acids.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR 30-50 mL/min: administer with caution, monitor fluid and electrolytes. For GFR <30 mL/min: dose reduction by 50% or consider essential amino acid formulation; avoid if severe azotemia or hyperkalemia. |
| Liver impairment | Child-Pugh class A: no adjustment. Class B: use with caution, reduce to 0.5-0.8 g/kg/day of amino acids. Class C: contraindicated unless product contains branched-chain amino acids; consider specialized formula. |
| Pediatric use | Intravenous; 2-3 g/kg/day of amino acids (0.3-0.5 g/kg/hour) for neonates and infants; 1-2 g/kg/day for older children. Adjust based on age, weight, and clinical condition. |
| Geriatric use | Initiate at low end of adult range (0.8-1 g/kg/day); monitor fluid status due to increased risk of volume overload; reduce rate if renal impairment present. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVASOL 8.5% W/O ELECTROLYTES (TRAVASOL 8.5% W/O ELECTROLYTES).
| Breastfeeding | Excretion in human milk unknown. Caution advised. M/P ratio not determined. |
| Teratogenic Risk | No adequate and well-controlled studies in pregnant women. Animal reproduction studies not available. Risk to fetus cannot be ruled out. Use only if clearly needed. |
| Fetal Monitoring | Monitor fluid balance, serum electrolytes, acid-base status, and blood glucose. Observe for signs of hypervolemia or electrolyte imbalance. |
■ FDA Black Box Warning
None
| Serious Effects |
Hypersensitivity to any component; inborn errors of amino acid metabolism; severe hepatic insufficiency with encephalopathy; severe renal insufficiency without dialysis; metabolic acidosis; hyperammonemia.
| Precautions | Risk of hyperammonemia, particularly in patients with hepatic insufficiency; risk of metabolic acidosis, electrolyte imbalances, and fluid overload; monitor serum ammonia, glucose, electrolytes, and renal function; use with caution in patients with renal or hepatic disease. |
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| Fertility Effects | No data on fertility effects in humans. No animal reproductive studies conducted. |