Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/650
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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. 50% and 70% Dextrose Injection, USP in the 2000 mL
flexible Pharmacy Bulk Package are designed for use with automated
compounding devices for preparing intravenous nutritional admixtures.
Dosages will be in accordance with the recommendation of the prescribing
physician. 50% and 70% Dextrose Injection, USP are not intended for
direct infusion. Admixtures should be made by, or under the direction
of, a pharmacist using strict aseptic technique under a laminar flow
hood. Compounded admixtures may be stored under refrigeration for
up to 24 hours. Administration of admixtures should be completed within
24 hours after removal from refrigeration. 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. 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. 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. Parenteral drug products should be inspected visually
for particulate matter and discoloration prior to administration,
whenever solution and container permit. See PRECAUTIONS. Drug Interactions Additives may be incompatible with the fluid withdrawn
from this container. Consult with pharmacist, if available. When compounding
admixtures, 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. Recommended
Directions for Use of the Pharmacy Bulk Package Use Aseptic Technique
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50% and 70% Dextrose Injection, USP (concentrated
dextrose in water) are sterile, nonpyrogenic, hypertonic solutions
of Dextrose, USP in water for injection for intravenous administration
after appropriate admixture or dilution. The
Pharmacy Bulk Package is a sterile dosage form which contains multiple
single doses for use only in a pharmacy bulk admixture program. The content and physical characteristics of the solutions
are as follows: * Caloric value calculated on the basis of 3.4
kcal/g of dextrose, hydrous. 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. This Pharmacy Bulk Package
is intended only for use in the preparation of sterile, intravenous
nutrient admixtures using automated compounding devices. 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). 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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50% and 70% Dextrose Injection, USP are supplied
as follows: Store at 20 to 25��C (68 to 77��F). [See
USP Controlled Room Temperature.] Protect from freezing. Covered by one or more of the following patents: 4,368,765. Revised:July, 2006 Hospira, Inc., Lake Forest, IL 60045 USA
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Pharmacy Bulk Package���Not For Direct Infusion. FOR USE ONLY WITH AUTOMATED COMPOUNDING DEVICES.
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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. Aseptic technique is essential
with the use of sterile preparations for compounding nutritional admixtures.
Discard container within 4 hours of entering closure. 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.<br/>General Precautions: N/A<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. Caution should
be exercised with low birth weight premature neonates, who are receiving
dextrose concentrations of10% or greater, as they are most susceptible
to glucose intolerance and hyperglycemia. 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.
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In the event of overhydration or solute overload
during therapy, re-evaluate 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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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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50% and 70% Dextrose Injection, USP (concentrated
dextrose in water) in Pharmacy Bulk Packages are indicated for use
with automated compounding devices for preparing intravenous nutritional
admixtures in the pharmacy.
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Dextrose
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