TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER (TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER).
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% is a parenteral nutrition solution providing amino acids, dextrose, and electrolytes. The amino acids serve as substrates for protein synthesis; dextrose supplies caloric energy; electrolytes maintain acid-base balance and osmotic equilibrium.
| Metabolism | Amino acids undergo deamination and transamination in the liver; dextrose is metabolized via glycolysis and the Krebs cycle; electrolytes are excreted or reabsorbed by renal mechanisms. |
| Excretion | Renal: 100% (primarily as free water and electrolytes; dextrose is metabolized; amino acids are deaminated and urea is excreted renally) |
| Half-life | Not applicable as a single agent; components have varying half-lives: dextrose ~2 h (glucose), amino acids ~1-3 h (plasma clearance), electrolytes proportional to renal function |
| Protein binding | Negligible for most components; amino acids: <20% (primarily albumin); dextrose: none; electrolytes: variable, e.g., calcium ~50% (albumin), magnesium ~30% (albumin) |
| Volume of Distribution | Not applicable as a mixture; approximate Vd for dextrose = 0.2 L/kg (extracellular fluid); electrolytes distribute in total body water (~0.6 L/kg for sodium, ~0.5 L/kg for chloride); amino acids Vd ~0.3-0.5 L/kg |
| Bioavailability | I.V. only: 100% |
| Onset of Action | I.V. infusion: immediate (within minutes) for electrolyte and fluid effects; dextrose effect on blood glucose within 1-5 minutes |
| Duration of Action | Dependent on infusion rate and renal function; typically 4-6 h for metabolic effects; electrolyte and fluid effects persist as long as infusion continues |
Intravenous infusion: 1-2 L/day as total parenteral nutrition; typical rate 100-125 mL/hour based on caloric and nitrogen needs.
| Dosage form | INJECTABLE |
| Renal impairment | Contraindicated in severe renal impairment (CrCl <25 mL/min) without CRRT; for CrCl 25-50 mL/min reduce volume by 50% and monitor electrolytes; CrCl >50 mL/min no adjustment. |
| Liver impairment | Child-Pugh A: no adjustment; Child-Pugh B: reduce amino acid dose by 50% and monitor ammonia; Child-Pugh C: contraindicated due to risk of encephalopathy. |
| Pediatric use | Starting dose: 0.5-1 g amino acids/kg/day, titrated up to 2-3 g/kg/day based on weight; typical volume 100-150 mL/kg/day for infants; adjust dextrose to maintain euglycemia. |
| Geriatric use | Start at lower end of dosing range (e.g., 0.5-1 L/day) with slower infusion rate (e.g., 50-75 mL/hour) due to decreased renal clearance; monitor glucose and electrolytes closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER (TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER).
| Breastfeeding | Excretion into breast milk of components is minimal; no specific M/P ratio reported. Considered compatible with breastfeeding if maternal nutritional status is adequate. Monitor infant for metabolic or electrolyte disturbances only if maternal therapy prolonged. |
| Teratogenic Risk | Amino acids, dextrose, and electrolytes in parenteral nutrition are not directly teratogenic. However, the solution is used for maternal nutritional support; no human data on direct fetal risks. Use only if clearly needed. No known structural teratogenicity; potential for metabolic disturbances if maternal homeostasis not maintained. |
■ FDA Black Box Warning
Contains sulfites which may cause allergic-type reactions including anaphylactic symptoms and life-threatening asthmatic episodes in susceptible individuals. Sulfite sensitivity is more common in asthmatics.
| Serious Effects |
["Inborn errors of amino acid metabolism (e.g., maple syrup urine disease, phenylketonuria).","Severe electrolyte imbalance or acid-base disorder.","Severe hyperglycemia (>250 mg/dL) not controlled with insulin.","Hypersensitivity to any component (including sulfites).","Uncorrected fluid overload or pulmonary edema."]
| Precautions | ["Risk of infection from catheter-related sepsis; strict aseptic technique required.","Fluid overload and electrolyte imbalances; monitor serum electrolytes, glucose, and fluid status.","Hyperglycemia may occur; insulin may be needed.","Refeeding syndrome in severely malnourished patients; initiate slowly and monitor phosphate, potassium, magnesium.","Hepatic cholestasis and steatosis with prolonged use; monitor liver function."] |
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| Fetal Monitoring | Monitor maternal serum electrolytes, blood glucose, acid-base balance, and renal function. Fetal assessment includes growth and well-being via ultrasound; in high-risk pregnancies, fetal heart rate monitoring as indicated. |
| Fertility Effects | No known direct adverse effects on fertility from the components. Infertility may be secondary to underlying maternal malnutrition; correction may improve fertility. No animal/human studies specific to this product. |