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Travasol

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Travasol

Warnings
Precautions

WARNINGS

This injection is for compounding only, not for direct infusion.

Caution should be exercised when admixing 10% Travasol® (Amino Acid) Injection. Studies have shown that admixtures of Travasol® (Amino Acid) Injection, 10% and 20% Travamulsion® Intravenous Fat Emulsion injection and high concentration dextrose injection (10 to 70%), from Baxter Healthcare Corporation, are stable over short periods of time. These solutions should be used promptly after admixing. Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours.

Reference should be made to Travamulsion® injection and high concentration dextrose injection from Baxter Healthcare Corporation package inserts for detailed information on each component.

Proper administration of this injection requires knowledge of fluid and electrolyte balance and nutrition as well as clinical expertise in recognition and treatment of the complications which may occur.

Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor and coma.

Hyperammonemia is of special significance in infants. This reaction appears to be related to a deficiency of the urea cycle amino acids of genetic or product origin. It is essential that blood ammonia be measured frequently in infants.

Conservative doses of this injection should be given to patients with known or suspected hepatic dysfunction. Should symptoms of hyperammonemia develop, administration should be discontinued and the patient's clinical status reevaluated.

Administration of amino acid solutions in the presence of impaired renal function presents special issues associated with retention of electrolytes.

This injection should not be administered simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination.

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 premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 g/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity.

Tissue loading may occur at even lower rates of administration.

Administration by central venous catheter should be used only by those familiar with this technique and its complications.

PRECAUTIONS

It is essential to provide adequate calories concurrently if parenterally administered amino acids are to be retained by the body and utilized for protein synthesis. Concentrated dextrose solutions are an effective source of such calories.

With the administration of 10% Travasol® (Amino Acid) Injection in combination with highly concentrated dextrose solutions, hyperglycemia, glycosuria and hyperosmolar syndrome may result. Blood and urine glucose should be monitored on a routine basis in patients receiving this therapy.

Sudden cessation in administration of a concentrated dextrose solution may result in insulin reaction due to continued endogenous insulin production. Parenteral nutrition mixtures should be withdrawn slowly.

Electrolytes may be added to this injection as dictated by the patient's electrolyte profile.

The metabolizable acetate anion and amino acid profile in this injection were designed to minimize or prevent occurrences of hyperchloremic metabolic acidosis and hyperammonemia. However, the physician should be aware of appropriate countermeasures if they become necessary.

Strongly hypertonic nutrient solutions should be administered through an indwelling intravenous catheter with the tip located in the superior vena cava.

Because of its antianabolic activity, concurrent administration of tetracycline may reduce the protein-sparing effects of infused amino acids.

Care should be taken to avoid excess fluid accumulation, particularly in patients with renal disease, pulmonary insufficiency and heart disease.

During protein-sparing therapy in the absence of supporting carbohydrate metabolism, an accumulation of ketone bodies in the blood often occurs. Correction of ketonemia usually can be accomplished by administering some carbohydrates.

Protein-sparing therapy is useful for periods up to 10 to 12 days. Patients requiring nutritional support thereafter should be placed on oral or parenteral regimens that employ adequate nonprotein calorie components.

Drug product contains no more than 25 g/L of aluminum.

Laboratory Tests

Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration.

Studies should include blood sugar, serum proteins, kidney and liver function tests, electrolytes, hemogram, carbon dioxide combining power or content, serum osmolarities, blood cultures and blood ammonia levels

Carcinogenesis and Mutagenesis and Impairment of Fertility

Studies with 10% Travasol® (Amino Acid) Injection have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility.

Pregnancy

Teratogenic Effects

Pregnancy Category C.

Animal reproduction studies have not been conducted with 10% Travasol® (Amino Acid) Injection. It is also not known whether 10% Travasol® (Amino Acid) Injection can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 10% Travasol® (Amino Acid) Injection should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when 10% Travasol® (Amino Acid) Injection is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of 10% Travasol® (Amino Acid) Injection in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature. See DOSAGE AND ADMINISTRATION.

Special Precautions

Administration of amino acid solutions and other nutrients via central or peripheral venous catheter may be associated with complications which can be prevented or minimized by careful attention to all aspects of the procedure. This includes attention to solution preparation, administration and patient monitoring. It is essential that a carefully prepared protocol, based on current medical practices, be followed, preferably by an experienced team.

Although a detailed discussion of the complications is beyond the scope of this insert, the following summary lists those based on current literature:

Technical

The placement of a central venous catheter should be regarded as a surgical procedure. The physician should be fully acquainted with various techniques of catheter insertion as well as recognition and treatment of complications. For details of techniques and placement sites consult the medical literature. X-ray is the best means of verifying catheter placement. Complications known to occur from the placement of central venous catheters are pneumothorax, hemothorax, hydrothorax, artery puncture and transection, injury to the brachial plexus, malposition of the catheter, formation of arterio-venous fistula, phlebitis, thrombosis, cardiac arrhythmia and catheter embolus.

Septic

The constant risk of sepsis is present during administration of parenteral nutrition solutions. Since contaminated solutions and infusion catheters are potential sources of infection, it is imperative that the preparation of the solution and the placement and care of catheters be accomplished under controlled aseptic conditions. If fever develops, the solution, its delivery system and the site of the indwelling catheter should be changed.

Solutions ideally should be prepared in the hospital pharmacy under a laminar flow hood. The key factor in their preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients.

Metabolic

The following metabolic complications have been reported: metabolic acidosis, hypophosphatemia, alkalosis, hyperglycemia and glycosuria, osmotic diuresis and dehydration, rebound hypoglycemia, elevated liver enzymes, hypo and hyper vitaminosis, electrolyte imbalances and hyperammonemia. Frequent clinical evaluation and laboratory determinations are necessary, especially during the first few days of therapy, to prevent or minimize these complications.

Last reviewed on RxList: 5/5/2009
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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