TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER
Clinical safety rating
cautionComprehensive 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 |
| Molecular Weight | Dextrose: 180.16 Da; Amino acids: vary (e.g., alanine: 89.09 Da, leucine: 131.18 Da). No single molecular weight for mixture. |
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 | TRAVASOL 4.25% with electrolytes and dextrose is a parenteral nutrition solution. No adequate studies in pregnant women. Use only if clearly needed. Dextrose may affect maternal glucose levels; monitor closely. |
| 2nd trimester | Parenteral nutrition may be used if necessary for maternal nutrition. Dextrose content requires monitoring of maternal blood glucose due to risk of hyperglycemia and potential fetal effects. |
| 3rd trimester | Use only if clearly indicated. Dextrose may cause maternal hyperglycemia, which can lead to fetal hyperinsulinemia and neonatal hypoglycemia. Electrolytes should be balanced carefully to avoid maternal or fetal electrolyte disturbances. |
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).
| Placental transfer | Amino acids, electrolytes, and dextrose cross the placenta via active transport and diffusion. Dextrose crosses freely; amino acids are actively transported to the fetus. Electrolytes (sodium, potassium, magnesium, calcium) are regulated by placental mechanisms. |
| Breastfeeding | The components of TRAVASOL (amino acids, electrolytes, dextrose) are endogenous substances and are generally compatible with breastfeeding. However, parenteral nutrition is typically used in hospitalized patients; if breastfeeding is initiated, monitor infant for any adverse effects. The manufacturer recommends caution due to lack of data. |
| Lactation Rating | L3: Moderately Safe (no known harm, but limited data; use with caution) |
| 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. |
| 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. |
■ 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 |
Known hypersensitivity to any componentSevere electrolyte disorders (unless corrected prior to infusion)Severe hyperglycemia (glucose > 300 mg/dL) with or without ketoacidosisSevere hepatic impairment with encephalopathySevere renal impairment with anuria or oliguria not on dialysis
| 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. |
| Food/Dietary | No direct food interactions, but patients may require adjustments to oral intake during parenteral nutrition transition. Avoid grapefruit juice if certain medications are co-administered (e.g., cyclosporine). |
| Clinical Pearls | TRAVASOL 4.25% with dextrose 15% is a hypertonic parenteral nutrition solution; must be administered via central venous catheter. Monitor serum electrolytes, glucose, and liver function tests. Adjust rate to avoid hyperglycemia or hypoglycemia. Contains no sulfite, suitable for sulfite-sensitive patients. Check for incompatibilities with other IV additives. |
| Patient Advice | This medication is a form of nutrition given through a vein when you cannot eat. · Your blood sugar and electrolytes will be monitored regularly. · Report any signs of infection (redness, swelling, pain) at the catheter site. · Do not adjust the infusion rate yourself; it is controlled by healthcare staff. · Inform your healthcare provider about all other medications you are taking. |
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