Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3487
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ProSol (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 20% PROSOL���sulfite-free (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 may 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 regimenwith full nonprotein
calorie substrates should be adopted. *Food and Nutrition
Board National Academy of Sciences - National Research Council (Revised
1989) 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. 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. Caution should be exercised in administering fat emulsions to
patients with severe liver damage, pulmonary disease, anemia or blood
coagulation disorders, or when there is danger of fat embolism. Fat emulsion
admixed into total parenteral formula may obscure the presence of
precipitate formation.<br/>Central Vein
Administration:: Hypertonic
mixtures of amino acids and dextrose may be administered safely
by continuous infusion through a central venous 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 a
concentrated dextrose solution may result in insulin reaction
due to high levels of endogenous insulin. Such solutions should
be withdrawn slowly.<br/>Peripheral Vein
Administration:: In patients
requiring parenteral nutrition for whom the central vein route
is not indicated, this injection can be mixed with low concentration dextrose solutions and administered by peripheral
vein with or without fat emulsion. Intravenous
fat emulsion provides 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,
this injection can be administered peripherally with or without
carbohydrate calories. Such infusates can be prepared by
dilution of this injection with 5% Dextrose Injection and/or
Sterile Water for Injection to prepare solutions which may be
administered by peripheral vein, not to exceed twice normal
serum osmolarity. 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 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. Filters of less than 1.2 microns pore size must
not be used with admixtures containing fatemulsions. A slight yellow color does not alter the quality and efficacy of the
product. Do not use
unless solution is clear and seal is intact. 20% PROSOL
- sulfite-free (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 20% PROSOL - sulfite-free (Amino Acid)
Injection. Any storage
of admixtures should be under refrigeration and limited to a
brief period of time, preferably less than 24 hours.
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20% PROSOL -
sulfite-free (Amino Acid) Injection is a sterile, nonpyrogenic,
hypertonic solution of essential and nonessential amino acids provided
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). 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 tests for plastic containers as well as by
tissue culture toxicity studies. Each 100 mL of 20%
PROSOL - sulfite-free (Amino Acid) Injection contains: (pH adjusted with
glacial acetic acid.)
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20% PROSOL -
sulfite-free (Amino Acid) Injection administered via central vein, after
appropriate dilution, will provide biologically utilizable source
material for protein synthesis when used with concentrated calorie
sources (such as hypertonic dextrose and/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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20% PROSOL -
sulfite-free (Amino Acid) Injection is supplied in VIAFLEX plastic
Pharmacy Bulk Package containers in the following sizes: 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): brief exposure up to 40��C/104��F does not
adversely affect the product. Do not remove
container from overpouch until ready to use. Do not use if
overpouch has been previously opened or damaged. Baxter Healthcare Corporation Clintec Nutrition
Division Deerfield, IL 60015
USA 07-19-41-037 Rev. December 2003 BAXTER, PROSOL,
VIAFLEX, and PL146 are trademarks of Baxter International
Inc.
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20% PROSOL -
sulfite-free (Amino Acid) Injection is a highly concentrated amino acid
solution used for the preparation of sterile total parenteral nutrition
admixtures . Some of the amino acids in 20% PROSOL -
sulfite-free (Amino Acid) Injection are close to their limit of
solubility, and, as such, a small number of amino acid crystals may form
upon storage. If aminoacid crystals are present, they will re-dissolve
upon dilution during admixture compounding. Do not use unless admixture
is free of visible particulate. Use of a final filter is recommended
during administration of all parenteral solutions where possible. 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 20% PROSOL - sulfite-free (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 high levels of endogenous insulin. Parenteral nutrition
mixtures should be withdrawn slowly. 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 effect 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. 20% PROSOL - sulfite-free (Amino Acid)
Injection is not intended for direct infusion, and, as such, should
never be administered undiluted. 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. Laboratory
tests should include blood glucose, serum electrolytes, liver
and kidney function, serum osmolarity, blood ammonia, serum
protein, pH, hematocrit, WBC and urinary glucose. When 20%
PROSOL - sulfite-free (Amino Acid) Injection is combined with
electrolytes, care should be used in administering this solution
to patients with congestive heart failure, renal failure, edema,
adrenal hyperactivity, acid base imbalance and those receiving
diuretics or antihypertensive therapy. Serum electrolytes should
be monitored daily. When 20% PROSOL - sulfite-free (Amino Acid)
Injection is infused without adequate non-protein calories,
monitoring of BUN is required.<br/>Carcinogenesis and
Mutagenesis and Impairment of Fertility: Studies
with 20% PROSOL - sulfite-free (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: It is not
known whether this drug is excreted in human milk. Because many
drugs are excreted in human milk, and because of the potential
for adverse reactions, e.g., hyperammonemia in nursing infants,
caution should be exercised when 20% PROSOL - sulfite-free
(Amino Acid) Injection is administered to a nursing
mother.<br/>Pediatric Use: Safety and
effectiveness of 20% PROSOL - sulfite-free (Amino Acid)
Injection have not been established by adequate and
well-controlled studies in pediatric patients.<br/>Geriatric Use: Clinical
studies of 20% PROSOL - sulfite-free (Amino Acid) Injection did
not include sufficient numbers of subjects aged 65 and over to
determine whether they respond differently from other younger
subjects. Other reported clinical experience has not identified
differences in responses between the elderly and younger
patients. In general, dose selection for an elderly patient
should be cautious, usually starting at the low end of the
dosing range, reflecting the greater frequency of decreased
hepatic, renal, or cardiac function, and of concomitant disease
or drug therapy.
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In the event of
overhydration or solute overload, re-evaluate the patient and institute
appropriate corrective measures. See CONTRAINDICATIONS and WARNINGS.
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Valine, Lysine, Histidine, Isoleucine, Leucine,
Phenylalanine, Threonine, Methionine, Tryptophan,
Alanine, Glycine, Arginine, Proline, Glutamic Acid,
Serine, Aspartic Acid and Tyrosine
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ProSol (Injection)
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See WARNINGS, PRECAUTIONS 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. Additives may be
incompatible. Consult with pharmacist, if available. When introducing
additives, use aseptic techniques. Mix thoroughly. Do not store. Because of the
potential for life-threatening events, caution should be taken to ensure
that precipitates have not formed in any parenteral nutrient admixture. Caution should be
exercised when admixing 20% PROSOL - sulfite-free (Amino Acid)
Injection. This solution 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 I.V.
Fat Emulsion package insert and high concentration dextrose injection
from Baxter Healthcare Corporation package insert for detailed
information on each component. Proper
administration of this injection requires a 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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20% PROSOL -
sulfite-free (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. 20% PROSOL - sulfite-free (Amino Acid) Injection can be
used to reduce fluid intake in patients who require both fluid
restriction and total parenteral nutrition (TPN). 20% PROSOL -
sulfite-free (Amino Acid) Injection is intended to be dosed on the basis
of grams of amino acids/kg body weight/day. Therefore, this more
concentratedamino acid solution provides the same nutritional value
(grams of total amino acids) as in a more dilute form, but with the
opportunity to limit fluid intake.<br/>Central Vein
Administration:: 20% PROSOL
- sulfite-free (Amino Acid) Injection is intended for use in a
pharmacy admixture program and as such is restricted to the
preparation of admixtures for intravenous use. 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. 20% PROSOL - sulfite-free (Amino Acid)infection should never be administered
undiluted.<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 with or without supplemented fat
emulsion. In pediatric patients, the final solution should not
exceed twice normal serum osmolarity (718 mOsmol/L). 20% PROSOL - sulfite-free (Amino Acid)
Injection should never be administered by peripheral vein
undiluted.<br/>Protein-Sparing:: Dilute
amino acid solutions for peripheral
administration may be used in patients who exhibit
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 dilute amino acid solutions
with or without dextrose. 20% PROSOL - sulfite-free (Amino Acid)
Injection must be diluted below twice normal serum osmolarity
(718 mOsmol/L).
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ProSol
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