TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER (TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER).
Provides parenteral nutrition with amino acids and dextrose to maintain nitrogen balance and provide caloric support in patients unable to tolerate oral or enteral feeding.
| Metabolism | Amino acids are metabolized via hepatic and extrahepatic tissues; dextrose undergoes glycolysis and oxidation via the Krebs cycle; no specific enzyme involvement. |
| Excretion | Amino acids are deaminated, with nitrogen excreted primarily as urea in urine (90-95%); small amounts excreted in feces (<5%) and bile (<1%). Dextrose is metabolized to CO2 and water. |
| Half-life | Not applicable as a single entity; amino acids have rapid clearance (minutes to hours), dextrose half-life <15 minutes under normal conditions. |
| Protein binding | Amino acids: minimal to moderate binding (e.g., tryptophan ~90% to albumin; others <20%). Dextrose: negligible. |
| Volume of Distribution | Amino acids: Vd ~0.2-0.5 L/kg (total body water). Dextrose: Vd ~0.2 L/kg (extracellular fluid, equilibrates with total body water). |
| Bioavailability | Intravenous: 100% (complete bioavailability). Not administered orally. |
| Onset of Action | Intravenous: nutritional support begins immediately upon infusion, with rise in plasma amino acids and glucose within minutes. |
| Duration of Action | Duration depends on infusion rate; after cessation, plasma levels decline rapidly (minutes to hours). Continuous infusion required for sustained effect. |
Intravenous infusion: 1.5 to 2.5 g amino acids/kg body weight per day (equivalent to 35-60 mL/kg per day of TRAVASOL 4.25% IN DEXTROSE 10%) as part of total parenteral nutrition. Infusion rate should not exceed 0.2 g amino acids/kg per hour.
| Dosage form | INJECTABLE |
| Renal impairment | For GFR 30-59 mL/min: reduce dose to 1.0-1.5 g amino acids/kg per day. For GFR 15-29 mL/min: 0.8-1.0 g/kg per day. For GFR <15 mL/min: 0.6-0.8 g/kg per day, with monitoring of serum electrolytes and acid-base balance. |
| Liver impairment | Child-Pugh Class A: standard dosing. Class B: reduce amino acid content to 1.0-1.2 g/kg per day and monitor ammonia levels. Class C: use with caution; consider branched-chain amino acid-enriched formulations; avoid if severe encephalopathy. |
| Pediatric use | Neonates: 1.0-3.0 g amino acids/kg per day; infants: 1.5-3.5 g/kg per day; children: 1.0-2.5 g/kg per day. Administer as continuous infusion. Adjust dextrose content to achieve desired caloric intake. |
| Geriatric use | No specific dose adjustment; initiate at lower end of dosing range (1.2-1.5 g amino acids/kg per day). Monitor renal function, fluid status, and electrolytes closely. Consider reduced metabolic reserve and comorbidities. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER (TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER).
| Breastfeeding | Limited data; components are endogenous and generally considered compatible with breastfeeding. M/P ratio not established. Use with caution, monitoring infant for gastrointestinal distress. |
| Teratogenic Risk | Amino acids and dextrose in balanced parenteral nutrition have no known teratogenic risk. As a standard component of total parenteral nutrition, no specific fetal risks have been identified in any trimester when used as clinically indicated. However, underlying maternal conditions requiring TPN may pose risks. |
■ FDA Black Box Warning
Not for intravenous injection as a single solution; contains no electrolytes and may cause metabolic complications if used without appropriate additives.
| Serious Effects |
["Severe hyperglycemia or hyperosmolar states","Anuria or severe renal impairment","Galactosemia (due to dextrose component)","Allergy to any component","Hypersensitivity to corn-derived products (for dextrose)"]
| Precautions | ["Risk of hyperglycemia and hyperosmolar syndrome, especially in diabetic or stressed patients","Can cause electrolyte imbalances, fluid overload, and metabolic acidosis","Monitor renal and hepatic function, serum glucose, and electrolyte levels","Do not use if solution is discolored or contains particles"] |
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| Fetal Monitoring | Monitor maternal serum electrolytes, blood glucose, acid-base status, and fluid balance. Fetal surveillance via ultrasound and nonstress test in high-risk pregnancies. Assess for signs of fluid overload or metabolic complications. |
| Fertility Effects | No known direct adverse effects on fertility. Correction of maternal nutritional deficiencies may improve fertility outcomes in malnourished patients. |