Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/312
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Dextrose (Injection, Solution)
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Concentrated Dextrose in Water is administered by
slow intravenous infusion (a) After admixture with amino acid solutions
or (b) After dilution with other compatible I.V. fluids. Dosage should
be adjusted to meet the requirements of each individual patient. The maximum rate at which dextrose can be infused
without producing glycosuria is 0.5 g/kg of body weight /hr. About
95% of the dextrose is retained when infused at a rate of 0.8 g/kg/hr. As reported in the literature, the dosage and constant
infusion rate of intravenous dextrose must be selected with caution
in pediatric patients, particularly neonates and low birth weight
infants, because of the increased risk of hyperglycemia/hypoglycemia. Clinical evaluation and periodic laboratory determinations
are necessary to monitor changes in fluid balance, electrolyte concentrations,
and acid-base balance during prolonged parenteral therapy or whenever
the condition of the patient warrants such evaluation. A list of nutritional admixture values is appended. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration,
whenever solution and container permit. See PRECAUTIONS. Drug Interaction Additives may be incompatible. Consult with pharmacist,
if available. When introducing additives, use aseptic technique, mix
thoroughly and do not store. Some opacity
of the plastic due to moisture absorption during sterilization process
may be observed. This is normal and does not affect the solution quality
or safety. The opacity will diminish gradually. WARNING: Do not use flexible container
in series connections.
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20%, 30%, 40%, 50% and 70% Dextrose Injection, USP
(concentrated dextrose in water) is a sterile, nonpyrogenic, hypertonic
solution of Dextrose, USP in water for injection for intravenous administration
after appropriate admixture or dilution. Partial-fill
containers, designed to facilitate admixture or dilution to provide
dextrose in various concentrations, are available in various sizes.
See table under HOW SUPPLIED for summary of content and characteristics
of these concentrated solutions. The solutions
contain no bacteriostat, antimicrobial agent or added buffer and are
intended only for use as a single-dose injection following admixture
or dilution. The flexible plastic container
is fabricated from a specially formulated polyvinylchloride. Water
can permeate from inside the container into the overwrap but not in
amounts sufficient to affect the solution significantly. Solutions
in contact with the plastic container may leach out certain chemical
components from the plastic in very small amounts; however, biological
testing was supportive of the safety of the plastic container materials. 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. Dextrose Injection,
USP is a parenteral fluid and nutrient replenisher. Dextrose, USP is chemically designated D-glucose, monohydrate
(CHO���HO),
a hexose sugar freely soluble in water. It has the following structural
formula: Water for Injection, USP is chemically designated HO.
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When administered intravenously, solutions containing
carbohydrate in the form of dextrose restore blood glucose levels
and provide calories. Carbohydrate in the form of dextrose may aid
in minimizing liver glycogen depletion and exerts a protein sparing
action. Dextrose injection undergoes oxidation to carbon dioxide and
water. Water is an essential constituent
of all body tissues and accounts for approximately 70% of total body
weight. Average normal adult daily requirement ranges from two to
three liters (1.0 to 1.5 liters each for insensible water
loss by perspiration and urine production, respectively). Water balance is maintained by various regulatory
mechanisms. Water distribution depends primarily on the concentration
of electrolytes in the body compartments, and sodium (Na) plays a major role in maintaining physiologic equilibrium.
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A concentrated dextrose solution should not be used
when intracranial or intraspinal hemorrhage is present nor in the
presence of delirium tremens if the patient is already dehydrated. Dextrose injection without electrolytes should not
be administered simultaneously with blood through the same infusion
set because of the possibility that pseudoagglutination of red cells
may occur.
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20%, 30%, 40%, 50% or 70% Dextrose Injection, USP
are supplied in single-dose partial-fill flexible containers. See
the following table. *Caloric value calculated on the basis of 3.4 kcal/g
of dextrose, hydrous. Store at 20 to 25��C (68 to 77��F). [See
USP Controlled Room Temperature.] Protect from freezing. Revised: July, 2006 Hospira, Inc., Lake Forest, IL 60045 USA
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Electrolyte deficits, particularly in serum potassium
and phosphate, may occur during prolonged use of concentrated dextrose
solutions. Blood electrolyte monitoring is essential, and fluid and
electrolyte imbalances should be corrected. Essential vitamins and
minerals also should be provided as needed. To minimize hyperglycemia and consequent glycosuria, it is desirable
to monitor blood and urine glucose and if necessary, add insulin.
When concentrated dextrose infusion is abruptly withdrawn, it is advisable
to follow with the administration of 5% or 10% dextrose to avoid rebound
hypoglycemia. Solutions containing dextrose
should be used with caution in patients with known subclinical or
overt diabetes mellitus. Care should be
exercised to insure that the needle (or catheter) is well within the
lumen of the vein and that extravasation does not occur. Concentrated dextrose solutions should not be administered
subcutaneously or intramuscularly. Do not
administer unless solution is clear and container is undamaged. Discard
unused portion.<br/>Pregnancy Category C.: Animal reproduction studies have not been conducted
with dextrose. It is also not known whether dextrose can cause fetal
harm when administered to a pregnant woman or can affect reproduction
capacity. Dextrose should be given to a pregnant woman only if clearly
needed.<br/>Pediatric Use:: The safety and effectiveness in the pediatric population
are based on the similarity of the clinical conditions of the pediatric
and adult populations. In neonates or very small infants the volume
of fluid may affect fluid and electrolyte balance. Frequent monitoring of serum glucose concentrations is required
when dextrose is prescribed to pediatric patients, particularly neonates
and low birth weight infants. In very low
birth weight infants, excessive or rapid administration of dextrose
injection may result in increased serum osmolality and possible intracerebral
hemorrhage. This product contains no more
than 25 mcg/L of aluminum.
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In the event of overhydration or solute overload
during therapy, reevaluate the patient and institute appropriate corrective
measures. See WARNINGS and PRECAUTIONS.
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Dextrose monohydrate
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Dextrose (Injection, Solution)
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Hyperosmolar syndrome, resulting from excessively
rapid administration of concentrated dextrose may cause hypovolemia,
dehydration, mental confusion and/or loss of consciousness. Reactions which may occur because of the solution
or the technique of administration include febrile response, infection
at the site of injection, venous thrombosis or phlebitis extending
from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the
infusion, evaluate the patient, institute appropriate therapeutic
countermeasures and save the remainder of the fluid for examination
if deemed necessary.
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| dailymed-instance:warning |
Concentrated dextrose in water should be administered
only after suitable dilution. Hypertonic dextrose solutions should
be given slowly. Significant hyperglycemia and possible hyperosmolar
syndrome may result from too rapid administration. The physician should
be aware of the symptoms of hyperosmolar syndrome, such as mental
confusion and loss of consciousness, especially in patients with chronic
uremia and those with known carbohydrate intolerance. The intravenous administration of these solutions can cause fluid
and/or solute overloading resulting in dilution of serum electrolyte
concentrations, overhydration, congested states or pulmonary edema. 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 mcg/kg/day accumulate aluminum
at levels associated with central nervous system and bone toxicity.
Tissue loading may occur at even lower rates of administration. FOR PERIPHERAL VEIN
ADMINISTRATION Hypertonic dextrose
solutions (above 5% concentration) should be given slowly, preferably
through a small bore needle into a large vein, to minimize venous
irritation. FOR CENTRAL VENOUS ADMINISTRATION Concentrated dextrose should be administered via central vein after
appropriate admixture or dilution when required.
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20%, 30%, 40%, 50% and 70% Dextrose Injection, USP
(concentrated dextrose in water) in partial-fill containers is indicated
for admixture with amino acids or dilution with other compatible I.V.
fluids to provide variable final dextrose concentrations for intravenous
infusion in patients whose condition requires parenteral nutrition.
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Dextrose
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