TRAVASOL 10% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVASOL 10% IN PLASTIC CONTAINER (TRAVASOL 10% IN PLASTIC CONTAINER).
Travasol 10% (amino acids injection) provides essential and non-essential amino acids for protein synthesis and nitrogen equilibrium in patients unable to obtain adequate nutrition orally or enterally. Amino acids are building blocks for proteins; they also serve as substrates for gluconeogenesis and other metabolic pathways.
| Metabolism | Amino acids are metabolized via transamination, deamination, and the urea cycle in the liver and other tissues. Individual amino acids follow specific catabolic pathways (e.g., branched-chain amino acids are metabolized in muscle). |
| Excretion | Renal excretion of infused amino acids and their metabolites; excess nitrogen excreted as urea in urine. ~90-95% of infused amino acids are utilized or excreted renally. Fecal excretion negligible. |
| Half-life | Not applicable as a single entity; constituent amino acids have half-lives varying from minutes to hours (e.g., 10-30 min for most). Clinical context: continuous infusion maintains steady state. |
| Protein binding | Amino acids are minimally protein-bound (<5%); primarily exist free in plasma. No significant binding to specific proteins. |
| Volume of Distribution | Vd approximately 0.3-0.5 L/kg for total amino acids, reflecting distribution primarily into extracellular fluid and lean body mass. Clinical meaning: rapid equilibration with body water compartments. |
| Bioavailability | 100% when administered intravenously; not available via oral or other routes (parenteral only). |
| Onset of Action | Intravenous: Immediate (within minutes) upon infusion start for metabolic effects; nitrogen balance improvement may take 24-48 hours. |
| Duration of Action | Intravenous: Duration corresponds to infusion period (metabolic effects persist hours after discontinuation). Clinical notes: short-term parenteral nutrition (days to weeks). |
Intravenous infusion: 500 mL to 2 L per day, administered at a rate not exceeding 4 mL/kg/h. Typical adult dose is 1-2 g protein/kg/day (equivalent to 10-20 mL/kg/day of 10% solution). Rate and volume are adjusted based on patient's metabolic needs and clinical status.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR 30-50 mL/min: reduce protein intake to 0.8-1 g/kg/day. For GFR 15-29 mL/min: reduce to 0.6-0.8 g/kg/day. For GFR <15 mL/min (dialysis): limit to 1.2 g/kg/day, monitor electrolytes. Travasol 10% is contraindicated in severe renal impairment without dialysis. |
| Liver impairment | Child-Pugh Class A: no adjustment. Child-Pugh Class B: reduce dose by 25-50% and monitor ammonia. Child-Pugh Class C: contraindicated due to risk of encephalopathy. |
| Pediatric use | Intravenous infusion: 2-3 g protein/kg/day for infants, 1.5-2 g/kg/day for children, administered as amino acid solution (10-20 mL/kg/day for 10% solution). Rate: start at 0.5-1 mL/kg/h, increase gradually up to 2-3 mL/kg/h. Adjust based on weight and clinical response. |
| Geriatric use | Start at lower end of adult dosing (0.8-1 g protein/kg/day) due to age-related reduced renal function. Monitor fluid status, electrolytes, and nitrogen balance. Avoid fluid overload; use with caution in patients with cardiac or renal impairment. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVASOL 10% IN PLASTIC CONTAINER (TRAVASOL 10% IN PLASTIC CONTAINER).
| Breastfeeding | Travasol 10% is excreted into breast milk. The M/P ratio is not established. It is generally considered compatible with breastfeeding when used for maternal nutrition. Monitor infant for metabolic disturbances if used long-term. |
| Teratogenic Risk | Travasol 10% (amino acids) is a standard component of parenteral nutrition. No teratogenic effects in humans have been reported. Use in pregnancy is considered safe when clinically indicated. No known risk of fetal malformations in any trimester. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Hypersensitivity to any component","Inborn errors of amino acid metabolism (e.g., maple syrup urine disease)","Severe hepatic failure with hyperammonemia without tailored formulation","Severe renal failure without appropriate dose adjustment and monitoring"]
| Precautions | ["Risk of hyperglycemia, hyperosmolar syndrome, and osmotic diuresis due to high dextrose concentrations if co-administered","Monitor fluid and electrolyte balance; avoid volume overload in patients with heart failure or renal impairment","Risk of metabolic acidosis or alkalosis depending on amino acid composition and clinical status","Use with caution in patients with hepatic or renal failure; adjust amino acid composition accordingly"] |
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| Fetal Monitoring |
| Monitor maternal electrolytes, acid-base status, fluid balance, and nutritional markers. Monitor fetal growth and amniotic fluid volume in prolonged parenteral nutrition. Check for signs of maternal metabolic complications (e.g., hyperglycemia, uremia). |
| Fertility Effects | No evidence of adverse effects on fertility. Parenteral nutrition may improve fertility in malnourished women by restoring nutritional status. |