TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER (TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER).
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES is a parenteral nutrition solution providing amino acids, electrolytes, and calories (as dextrose). Amino acids are used for protein synthesis, and electrolytes maintain acid-base balance and osmotic pressure.
| Metabolism | Amino acids are metabolized via deamination, transamination, and urea cycle in the liver. Dextrose is metabolized via glycolysis and oxidative phosphorylation. Electrolytes are not metabolized. |
| Excretion | Renal: >95% of infused amino acids and electrolytes are excreted unchanged or as metabolites. Biliary/fecal: <5%. |
| Half-life | Not applicable as a fixed half-life; amino acids have rapid plasma clearance (t1/2 of 10-30 minutes for individual amino acids). Clinical context: Continuous infusion maintains steady state. |
| Protein binding | Minimal for amino acids (<10% bound to albumin); electrolytes are not protein-bound. |
| Volume of Distribution | Amino acids: 0.3-0.5 L/kg (total body water). Electrolytes: Na+ 0.6 L/kg, K+ 4 L/kg, Mg2+ 0.5 L/kg, Cl- 0.3 L/kg, acetate<0.1 L/kg. |
| Bioavailability | IV: 100%. Not administered by other routes. |
| Onset of Action | IV infusion: Immediate for plasma amino acid levels and electrolyte correction; clinical effects (e.g., protein synthesis) occur within hours of administration. |
| Duration of Action | Duration depends on infusion rate; effects persist during continuous infusion. After cessation, plasma levels decline rapidly (minutes to hours). |
Intravenous infusion of 3.5% amino acid solution at a rate of 1-2 mL/kg/hour, adjusted to meet metabolic needs. Typical adult daily dose: 0.8-1.5 g amino acids/kg/day, equivalent to 23-43 mL/kg/day of TRAVASOL 3.5%.
| Dosage form | INJECTABLE |
| Renal impairment | In acute kidney injury or chronic kidney disease with GFR <30 mL/min/1.73 m², restrict protein intake to 0.6-0.8 g/kg/day; monitor electrolytes closely. For GFR 30-60 mL/min/1.73 m², consider reducing dose to 0.8-1.0 g/kg/day. No specific guidelines for hemodialysis. |
| Liver impairment | In severe hepatic impairment (Child-Pugh C), use with caution; consider branched-chain amino acid enriched solutions; reduce amino acid dose to 0.5-1.0 g/kg/day. Child-Pugh B: no specific adjustment, but monitor for hyperammonemia. |
| Pediatric use | Neonates and infants: 2-3 g amino acids/kg/day; children 1-12 years: 1.5-2 g/kg/day. Administer as continuous IV infusion; adjust based on nitrogen balance and growth. |
| Geriatric use | No specific geriatric adjustment; use lowest effective dose, monitor renal function and fluid status due to increased risk of fluid overload and electrolyte imbalances. Typical dose: 0.8-1.0 g amino acids/kg/day. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER (TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER).
| Breastfeeding | Amino acids and electrolytes are normal components of breast milk. TRAVASOL 3.5% is unlikely to affect the nursing infant. M/P ratio not available; however, infusion of balanced amino acids and electrolytes is considered compatible with breastfeeding. |
| Teratogenic Risk | Amino acid and electrolyte solutions are generally considered low risk for teratogenicity. No specific fetal risks have been identified in animal studies; however, maternal malnutrition or electrolyte imbalances may indirectly affect fetal development. Use during pregnancy only if clearly needed. |
■ FDA Black Box Warning
WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are at greater risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.
| Serious Effects |
["Patients with severe electrolyte imbalances or fluid overload.","Anuria or end-stage renal disease without dialysis.","Inborn errors of amino acid metabolism.","Severe liver disease with hepatic encephalopathy."]
| Precautions | ["Use only if solution is clear and container undamaged.","Risk of infection and sepsis from catheter use.","Monitor fluid and electrolyte balance, blood glucose, liver function, and renal function.","Aluminum toxicity risk (see black box warning).","Sulfite-free formulation reduces risk of allergic reactions in sulfite-sensitive patients.","Avoid rapid infusion to prevent hyperglycemia and osmotic diuresis."] |
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| Fetal Monitoring | Monitor maternal serum electrolytes, acid-base balance, blood glucose, and renal function. In prolonged use, monitor for signs of volume overload or electrolyte imbalances. Fetal monitoring is not specifically required but may be considered if maternal condition warrants. |
| Fertility Effects | No known adverse effects on fertility. Adequate nutrition and electrolyte balance are essential for reproductive function; deficiency states may impair fertility. |