Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2047
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Travasol (Injection)
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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
Allowancesof 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.<br/>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).<br/>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.<br/>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.<br/>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, useaseptic 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.
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10%
Travasol(Amino Acid) Injection is a sterile, nonpyrogenic
hypertonic solution of essential and nonessential amino acids in a
Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a
sterile preparation for parenteral use that contains many single doses.
The contents are intended for use in a pharmacy admixture program and
are restricted to the preparation of admixtures for intravenous
infusion. The
Viaflex plastic container is fabricated from a specially
formulated polyvinyl chloride (PL 146 Plastic). Exposure to
temperatures above 25��C/77��F during transport and storage will lead to
minor losses in moisture content. Higher temperatures lead to greater
losses. It is unlikely that these minor losses will lead to clinically
significant changes within the expiration period. The amount of water
that can permeate from inside the container into the overwrap is
insufficient to affect the solution significantly. Solutions in contact
with the plastic container can leach out certain of its chemical
components in very small amounts within the expiration period, e.g.,
di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million; however,
the safety of the plastic has been confirmed in tests in animals
according to USP biological test for plastic containers as well as by
tissue culture toxicity studies. Each 100 mL of 10%
Travasol (Amino Acid) Injection contains: (pH adjusted with
glacial acetic acid and may have been adjusted with sodium hydroxide.)
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10%
Travasol (Amino Acid) Injection administered via central
vein will provide biologically utilizable source material for protein
synthesis when used with concentrated calorie sources (such as
hypertonic dextrose or fat emulsion), electrolytes, vitamins, and
minerals. Administered peripherally after appropriate dilution or with
minimal calorie supplementation (such as 5% dextrose), it enhances the
conservation of body protein.
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Hypersensitivity to
one or more amino acids Severe liver
disease or hepatic coma Anuria
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10%
Travasol (Amino Acid) Injection is available in
Viaflex plastic Pharmacy Bulk Package containers as
follows below. 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 (25��C/77��F). 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 07-19-12-844 Rev. July 2002
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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.<br/>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<br/>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.<br/>Pregnancy:<br/>Teratogenic
Effects:<br/>Nursing Mothers: Caution
should be exercised when 10% Travasol (Amino Acid)
Injection is administered to a nursing woman.<br/>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.
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See CONTRAINDICATIONS and WARNINGS
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Leucine, Phenylalanine, Lysine hydrochloride,
Methionine, Isoleucine, Valine, Histidine, Threonine,
Tryptophan, Alanine, Glycine, Arginine, Proline,
Tyrosine, Serine
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Travasol (Injection)
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See WARNINGS
and SPECIAL PRECAUTIONS. Infusion of any
hypertonic solution can result in local inflammatory reactions. Policies
and procedures should be established for the recognition and management
of such reactions.
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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.
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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.<br/>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.<br/>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.<br/>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.
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Travasol
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