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Travasol

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Travasol

Indications
Dosage
How Supplied

INDICATIONS

10% Travasol® (Amino Acid) Injection is indicated as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where: (1) the alimentary tract cannot or should not be used, (2) gastrointestinal absorption of protein is impaired, or (3) metabolic requirements for protein are substantially increased, as with extensive burns.

Central Vein Administration

Central vein infusion should be considered when amino acid solutions are to be admixed with hypertonic dextrose to promote protein synthesis such as for hypercatabolic or depleted patients or those requiring long term parenteral nutrition.

Peripheral Vein Administration

For patients in whom the central vein route is not indicated, amino acid solutions diluted with low dextrose concentrations may be infused by peripheral vein when supplemented with or without fat emulsion.

Protein-Sparing

Dilute amino acid solutions for peripheral administration may be used in patients who exemplify no clinically significant protein malnutrition. The purpose of the solution is to replace protein losses which occur in relation to an intercurrent phenomenon which is known or suspected to be productive of a protein loss condition for a short or moderate period of time. Protein-sparing can be achieved by peripheral infusion of amino acid solutions with or without dextrose.

DOSAGE AND ADMINISTRATION

If a patient is unable to take enteral nourishment for a prolonged period of time, institution of total parenteral nutrition (TPN) with exogenous calories should be considered.

The total daily dose of 10% Travasol® (Amino Acid) Injection depends on the patient's metabolic requirement and clinical response. The determination of nitrogen balance and accurate daily body weights, corrected for fluid balance, are probably the best means of assessing individual nitrogen requirements.

Recommended Dietary Allowances* of protein range from approximately 0.75 g/kg of body weight for adults to 1.68 g/kg for infants. It must be recognized, however, that protein as well as caloric requirements in traumatized or malnourished patients may be increased substantially. Daily amino acid doses of approximately 1.0 to 1.5 g/kg of body weight for adults with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance.

For the initial treatment of trauma or protein calorie malnutrition, higher doses of protein with corresponding quantities of carbohydrate will be necessary to promote adequate patient response to therapy. The severity of the illness being treated is the primary consideration in determining proper dose level. Such higher doses, especially in infants, must be accompanied by more frequent laboratory evaluation.

For protein-sparing in well-nourished patients not receiving significant additional calories, amino acid dosages of 1.0 to 1.7 g/kg/day reduce nitrogen losses and spare body protein. If daily increases in BUN in the range of 10 to 15 mg% for more than three days should occur, then protein-sparing therapy should be discontinued and a regimen with full nonprotein calorie substrates should be adopted.

Care should be exercised to insure the maintenance of proper levels of serum potassium. Quantities of 60 to 180 mEq of potassium per day have been used with adequate clinical effect. It may be necessary to add quantities of this electrolyte to this injection, depending primarily on the amount of carbohydrate administered to and metabolized by the patient.

This injection provides a concentrated source of amino acids to meet the protein requirements of patients that are fluid restricted (e.g., renal failure). Acceptable total daily administration volumes are dependent upon the fluid balance requirements of the patient.

Extreme care should be given to prevent fluctuations of blood osmolarity and serum electrolyte concentrations. Frequent and careful monitoring is mandatory when fluid restricted patients are receiving intravenous nutrition.

Patients receiving this injection should be monitored (carefully) and their electrolyte requirements individualized.

Total daily fluid requirements can be met beyond the volume of amino acid solutions by supplementing with noncarbohydrate or carbohydrate-containing electrolyte solutions.

Maintenance vitamins, additional electrolytes and trace elements should be administered as required.

Fat emulsion coadministration should be considered when prolonged parenteral nutrition (more than 5 days) is required in order to prevent essential fatty acid deficiency (EFAD). Serum lipids should be monitored for evidence of EFAD in patients maintained on fat free total parenteral nutrition.

Pediatric Use

Use of 10% Travasol® (Amino Acid) Injection in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L).

Central Vein Administration

Hypertonic mixtures of amino acids and dextrose may be administered safely by continuous infusion through a central vein catheter with the tip located in the vena cava. In addition to meeting nitrogen needs, the administration rate is governed, especially during the first few days of therapy, by the patient's tolerance to dextrose. Daily intake of amino acids and dextrose should be increased gradually to the maximum required dose as indicated by frequent determinations of urine and blood sugar levels.

In many patients, provision of adequate calories in the form of hypertonic dextrose may require the administration of exogenous insulin to prevent hyperglycemia and glycosuria.

Parenteral nutrition may be started with infusates containing lower concentrations of dextrose; dextrose content may be gradually increased to estimated caloric needs as the patient's glucose tolerance increases.

Sudden cessation in administration of concentrated dextrose solution may result in insulin reaction due to continued endogenous insulin production. Such solutions should be withdrawn slowly.

Peripheral Vein Administration:

For patients requiring parenteral nutrition in whom the central vein route is not indicated, this injection can be mixed with low concentration dextrose solutions and administered by peripheral vein in conjunction with or without fat emulsions. In pediatric patients, the final solution should not exceed twice normal serum osmolarity (718 mOsmol/L).

Intravenous fat emulsions provide approximately 1.1 kcal/mL (10%) or 2.0 kcal/mL (20%) and may be administered along with amino acid-dextrose solutions by means of a short Y-connector near the infusion site to supplement caloric intake. Fat, however, should not be the sole caloric intake since studies have indicated that glucose is more nitrogen sparing in the stressed patient.

Protein-Sparing:

For well-nourished patients who require short-term parenteral support, 10% Travasol® (Amino Acid) Injection can be administered peripherally with or without carbohydrate calories. Such infusates can be prepared by dilution of this injection with Sterile Water for Injection or 5% Dextrose Injection to prepare isotonic or slightly hypertonic solutions which may be administered by peripheral vein. Depending upon the clinical condition of the patient, approximately 3 liters of solution may be administered per 24 hour period. When used postoperatively, the therapy should begin with 1000 mL on the first postoperative day. Thereafter, the dose may be increased to 3000 mL per day.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible.

Do not administer unless solution is clear and seal is intact.

A slight yellow color does not alter the quality and efficacy of the product.

10% Travasol® (Amino Acid) Injection in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of 10% Travasol® (Amino Acid) Injection. Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours.

DIRECTIONS FOR USE OF VIAFLEX® PLASTIC PHARMACY BULK PACKAGE CONTAINER

To Open

Tear overpouch down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

For compounding only, not for direct infusion.

Preparation for Admixing

  1. The Pharmacy Bulk Package is to be used only in a suitable work area such as a laminar flow hood (or an equivalent clean air compounding area).
  2. Suspend container from eyelet support.
  3. Remove plastic protector from outlet port at bottom of container.
  4. Attach solution transfer set. Refer to complete directions accompanying set. Note: The closure shall be penetrated only one time with a suitable sterile transfer device or dispensing set which allows measured dispensing of the contents.
  5. Viaflex® containers should not be written on directly since ink migration has not been investigated. Affix accompanying label for date and time of entry,
  6. Once container closure has been penetrated, withdrawal of contents should be completed without delay. After initial entry, maintain contents at room temperature (25C/77F) and dispense within 4 hours.

HOW SUPPLIED

10% Travasol® (Amino Acid) Injection is available in Viaflex® plastic Pharmacy Bulk Package containers as follows below.

1B6623 500 mL NDC 0338-0644-03
1B6624 1000 mL NDC 0338-0644-04
1B6626 2000 mL NDC 0338-0644-06

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat Protect from freezing. It is recommended the product be stored at room temperature (25C/77F).

Do not remove container from overpouch until ready to use.

Do not use if overpouch has been previously opened or damaged.

*Food and Nutrition Board National Academy of Sciences - National Research Council (Revised 1989)
Baxter Healthcare Corporation. Clintec Nutrition Division Deerfield, IL 60015 USA. Rev. July 2002

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

Indications
Dosage
How Supplied
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