TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER (TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER).
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER is a parenteral nutrition solution that provides a source of amino acids, electrolytes, and calories. The amino acids serve as substrates for protein synthesis and energy metabolism, replenishing nitrogen balance and supporting tissue repair and growth.
| Metabolism | Amino acids are metabolized via transamination, deamination, and urea cycle in the liver and other tissues. Electrolytes are not metabolized but are utilized for physiological processes. |
| Excretion | Renal: Amino acids are extensively reabsorbed; excess nitrogen is excreted as urea (renal, majority). Electrolytes are excreted renally with reabsorption regulation. Biliary/fecal: Negligible. |
| Half-life | Amino acids have short half-lives (minutes to hours) due to rapid metabolism; no single terminal half-life for mixture. Electrolytes have distribution half-lives of minutes. |
| Protein binding | Amino acids: Low to moderate binding to plasma proteins, variable by amino acid (e.g., tryptophan ~75% bound to albumin). Electrolytes: Minimal protein binding (e.g., potassium <5%). |
| Volume of Distribution | Amino acids distribute widely to total body water (~0.5-0.7 L/kg) and tissues. Electrolytes distribute according to their compartments (e.g., sodium Vd ~0.2 L/kg). |
| Bioavailability | Intravenous: 100% bioavailable. Other routes: Not applicable; parenteral amino acid solutions must be given intravenously due to gastrointestinal metabolism. |
| Onset of Action | Intravenous: Metabolic effects begin immediately upon infusion; amino acid incorporation into proteins occurs within minutes to hours. |
| Duration of Action | Intravenous: Effects persist as long as infusion continues; metabolic benefits sustained with continuous administration. |
Intravenous infusion. Individualized based on protein and electrolyte requirements. Typical adult dose: 500-2000 mL/day of 8.5% amino acid solution, infused at 60-125 mL/hour.
| Dosage form | INJECTABLE |
| Renal impairment | In acute kidney injury or chronic kidney disease, reduce nitrogen load. For GFR < 50 mL/min: limit protein intake to 0.6-0.8 g/kg/day; use with caution and monitor electrolytes. For GFR < 30 mL/min: may require specialized renal replacement formula. |
| Liver impairment | In hepatic encephalopathy (Child-Pugh B or C), avoid or use with caution due to risk of precipitating encephalopathy; consider branched-chain amino acid enriched solutions. |
| Pediatric use | Weight-based: 2-3 g amino acids/kg/day (equivalent to 24-35 mL/kg/day of 8.5% solution). Initiate at lower doses (0.5-1 g/kg/day) and titrate. Infusion rate: 0.1 g/kg/hour, increase gradually. |
| Geriatric use | Elderly patients may require lower total protein intake (0.8-1.0 g/kg/day) due to reduced renal function. Monitor fluid and electrolyte balance closely. Infusion rate: 60-80 mL/hour. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER (TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER).
| Breastfeeding | Compatible with breastfeeding; amino acids and electrolytes are normal components of human milk. M/P ratio not established; infusion of standard parenteral nutrition does not pose significant risk to nursing infant. |
| Teratogenic Risk | No evidence of teratogenicity in animal studies; amino acids and electrolytes are normal constituents of maternal and fetal plasma. First trimester: No known increased risk of major malformations. Second/Third trimester: No known adverse fetal effects when used as indicated for parenteral nutrition. Risk may increase with maternal metabolic abnormalities. |
■ FDA Black Box 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 particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including preterm neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.
| Serious Effects |
["Hypersensitivity to any component","Severe hyperglycemia or hyperosmolality (uncontrolled diabetes mellitus)","Severe hepatic failure with hyperammonemia","Inborn errors of amino acid metabolism (e.g., maple syrup urine disease, phenylketonuria)","Severe renal impairment not on dialysis (unless tailored amino acid solution)","Anuria or oliguria","Hemodynamically unstable patients with pulmonary edema"]
| Precautions | ["Risk of hyperglycemia due to glucose content","Fluid and electrolyte imbalances","Aluminum toxicity with prolonged use, especially in renal impairment","Infectious complications including sepsis from catheter-related infection","Thrombophlebitis at infusion site","Hepatic steatosis and cholestasis with long-term use","Pulmonary complications if air embolism occurs"] |
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| Fetal Monitoring | Monitor maternal fluid balance, electrolytes, renal function, blood glucose, and serum osmolality. Fetal monitoring: assess growth and well-being with serial ultrasound if long-term parenteral nutrition; watch for maternal metabolic complications affecting fetus. |
| Fertility Effects | No known adverse effects on fertility from electrolyte and amino acid components; underlying maternal nutritional deficiency may impact fertility. |