TRAVASOL 8.5% IN PLASTIC CONTAINER
Clinical safety rating: caution
Comprehensive clinical and safety monograph for TRAVASOL 8.5% IN PLASTIC CONTAINER (TRAVASOL 8.5% IN PLASTIC CONTAINER).
TRAVASOL 8.5% is a crystalline amino acid solution that provides essential and non-essential amino acids for protein synthesis, tissue repair, and maintenance of nitrogen balance in patients unable to tolerate enteral nutrition.
| Metabolism | Amino acids are metabolized via deamination, transamination, and oxidative pathways primarily in the liver. Nitrogen is incorporated into urea via the urea cycle. |
| Excretion | Renal elimination of nitrogenous waste products (urea, ammonia) derived from amino acid metabolism; biliary/fecal excretion negligible. In healthy adults, >90% of infused amino nitrogen is ultimately excreted as urea in urine. |
| Half-life | Not applicable; constituent amino acids have individual half-lives (e.g., 0.5–2 hours for most L-amino acids) but overall elimination follows zero-order kinetics during continuous infusion. Clinically, infusion rate determines steady-state concentrations. |
| Protein binding | Minimal (<10%) for individual amino acids; binding to albumin or other plasma proteins is negligible. Transport is primarily via specific carrier-mediated processes. |
| Volume of Distribution | Approximately 0.3–0.5 L/kg for total amino acids, reflecting distribution into total body water and intracellular compartments. Higher distribution for branched-chain amino acids (leucine, isoleucine, valine) into muscle. |
| Bioavailability | Intravenous: 100% (complete). Not administered orally; if taken orally, amino acids are absorbed with bioavailability >90% but first-pass metabolism reduces systemic availability of some (e.g., glutamine, alanine). |
| Onset of Action | Intravenous infusion: nitrogen balance improvement observed within 24–48 hours; plasma amino acid levels rise immediately upon infusion initiation. |
| Duration of Action | Duration of positive nitrogen balance persists for several hours after infusion cessation, depending on metabolic demands. Continuous or cyclic infusion is required to maintain effect. |
Intravenous administration as total parenteral nutrition: typical adult dose is 8.5% amino acid solution at 0.8-1.5 g protein/kg/day, infused continuously or cyclically.
| Dosage form | INJECTABLE |
| Renal impairment | GFR 30-59 mL/min: reduce to 0.5-0.8 g protein/kg/day; GFR <30 mL/min: 0.4-0.5 g/kg/day; monitor BUN and electrolytes. |
| Liver impairment | Child-Pugh Class A: no adjustment; Class B: reduce to 0.6-0.8 g protein/kg/day; Class C: 0.4-0.6 g/kg/day; avoid in hepatic encephalopathy. |
| Pediatric use | Weight-based: 1.0-2.5 g protein/kg/day intravenously, adjusted for age and clinical status; neonates: 1.5-3.0 g/kg/day. |
| Geriatric use | Start at lower end of adult range (0.8-1.0 g/kg/day) and titrate based on renal function and metabolic tolerance; monitor fluid and electrolyte balance closely. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for TRAVASOL 8.5% IN PLASTIC CONTAINER (TRAVASOL 8.5% IN PLASTIC CONTAINER).
| Breastfeeding | TRAVASOL 8.5% is a sterile, hypertonic amino acid solution for intravenous infusion. It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when TRAVASOL 8.5% is administered to a nursing woman. The molecular weight of amino acids (< 200 Da) suggests potential for transfer into breast milk, but clinical significance is low due to endogenous presence. M/P ratio: not established. |
| Teratogenic Risk | Amino acid solutions like TRAVASOL 8.5% are essential for maternal nutrition in pregnancy; however, there are no well-controlled studies in pregnant women. Animal reproduction studies have not been conducted. Use during pregnancy only if clearly needed. First trimester: potential risks are not established; avoid unless maternal benefit outweighs unknown fetal risk. Second and third trimesters: may be used cautiously for nutritional support, with monitoring for electrolyte imbalances and fluid overload in the fetus. |
■ FDA Black Box Warning
Not for use in patients with severe hepatic failure, severe uremia, or inborn errors of amino acid metabolism. Risk of hyperammonemia and metabolic acidosis.
| Serious Effects |
["Severe hepatic failure","Severe uremia","Inborn errors of amino acid metabolism (e.g., phenylketonuria)","Hypersensitivity to any component","Uncorrected metabolic acidosis","Pulmonary edema or congestive heart failure"]
| Precautions | ["Monitor serum electrolytes, blood urea nitrogen, ammonia, and acid-base balance regularly","Use with caution in patients with renal or hepatic impairment","Risk of hyperglycemia, hypophosphatemia, and metabolic bone disease with long-term use","Do not administer simultaneously with blood products via same IV line"] |
Loading safety data…
| Fetal Monitoring | Monitor maternal serum electrolytes, blood glucose, liver function, renal function, acid-base balance, and serum ammonia. In pregnancy, monitor fetal heart rate and uterine activity during infusion. Assess fluid balance to prevent overload. Check for signs of hyperammonemia, hyperglycemia, or electrolyte disturbances both in mother and fetus. |
| Fertility Effects | No specific studies on fertility effects with TRAVASOL 8.5%. As a nutritional supplement, it is not expected to impair fertility. However, underlying malnutrition corrected by treatment may improve fertility. |