TRAVASOL 5.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVASOL 5.5% IN PLASTIC CONTAINER (TRAVASOL 5.5% IN PLASTIC CONTAINER).
Travasol 5.5% is a crystalline amino acid solution that provides essential and nonessential amino acids for protein synthesis, maintaining nitrogen balance, and supporting metabolic functions in parenteral nutrition.
| Metabolism | Amino acids are metabolized via transamination, deamination, and urea cycle pathways primarily in the liver; carbon skeletons enter gluconeogenesis or citric acid cycle. |
| Excretion | Amino acids in TRAVASOL 5.5% are metabolized and nitrogen waste is excreted primarily via renal elimination (as urea, >90% of nitrogen). Fecal elimination is negligible (<2%). |
| Half-life | Not applicable as individual amino acids have variable half-lives (minutes to hours). TRAVASOL is a mixture; the clinical context is continuous infusion to maintain plasma levels. |
| Protein binding | <5% bound to plasma proteins; amino acids are primarily free in circulation. |
| Volume of Distribution | Not defined as a single value; amino acids distribute into total body water (~0.45-0.6 L/kg). Clinical meaning: rapid distribution into extracellular and intracellular spaces. |
| Bioavailability | Intravenous: 100% (not applicable for enteral routes; no bioavailability data). |
| Onset of Action | Intravenous: Nutritional effects (nitrogen balance, protein synthesis) become detectable within 24-48 hours of continuous infusion. |
| Duration of Action | Effects last as long as infusion continues; after discontinuation, plasma amino acid levels decline rapidly within 1-2 hours. Prolonged effects require ongoing administration. |
500 mL of 5.5% amino acid solution intravenously over 2-4 hours daily, titrated to nitrogen balance and metabolic tolerance.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in severe renal impairment (GFR <25 mL/min) unless on dialysis; for GFR 25-50 mL/min, use with caution and monitor BUN; no specific dose reduction established. |
| Liver impairment | Child-Pugh C: contraindicated due to risk of encephalopathy; Child-Pugh A/B: use with caution, reduce dose by 50% and monitor ammonia levels. |
| Pediatric use | Infants and children: 2-3 g amino acids/kg/day (equivalent to 36-54 mL/kg/day of 5.5% solution) intravenously, adjusted based on metabolic response and growth. |
| Geriatric use | No specific dose adjustment; monitor renal function and metabolic tolerance; start at lower end of dosing range (e.g., 250-500 mL/day) due to potential decreased renal reserve. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVASOL 5.5% IN PLASTIC CONTAINER (TRAVASOL 5.5% IN PLASTIC CONTAINER).
| Breastfeeding | This drug is administered intravenously and its components are endogenous substances. Amino acids are normally present in breast milk. No specific M/P ratio is available. Use is considered compatible with breastfeeding when clinically indicated. |
| Teratogenic Risk | Travasol 5.5% is a crystalline amino acid solution used for parenteral nutrition. No teratogenic effects have been reported with its use during pregnancy. Adequate nutrition is essential for fetal development, and deficiencies may be harmful. Therefore, the benefit of correcting maternal nutritional deficiency likely outweighs potential risks. No specific trimester risks are documented. |
■ FDA Black Box Warning
None
| Serious Effects |
["Hypersensitivity to any component","Inborn errors of amino acid metabolism","Severe hepatic failure with encephalopathy","Severe renal failure without dialysis access"]
| Precautions | ["Risk of metabolic acidosis","Hyperammonemia, especially in patients with hepatic insufficiency","Electrolyte imbalances","Fluid overload","Thrombophlebitis if administered peripherally without adequate dilution"] |
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| Fetal Monitoring | Monitor maternal renal function, fluid and electrolyte balance, acid-base status, and blood glucose. Assess fetal growth and well-being if prolonged use or maternal metabolic disturbances occur. |
| Fertility Effects | No evidence of adverse effects on fertility from Travasol 5.5% when used as indicated. |