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
- 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).
- Suspend container from eyelet support.
- Remove plastic protector from outlet port at bottom of container.
- 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.
- Viaflex® containers should not be written on directly since ink migration
has not been investigated. Affix accompanying label for date and time of entry,
- Once container closure has been penetrated, withdrawal of contents should
be completed without delay. After initial entry, maintain contents at room
temperature (25ºC/77ºF) and dispense within 4 hours.
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