Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1174
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Dextrose and Sodium Chloride (Injection, Solution)
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| dailymed-instance:dosage |
The dose is dependent upon the age, weight and clinical condition
of the patient. 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. Consult with pharmacist, if available. When introducing
additives, use aseptic technique, mix thoroughly and do not store.
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| dailymed-instance:descripti... |
Dextrose and Sodium Chloride Injection, USP solutions are
sterile and nonpyrogenic. They are large volume parenteral solutions containing
various concentrations and combinations of these drugs in water for injection
intended for intravenous administration. See Table for
summary of content and characteristics of these solutions. The
solutions contain no bacteriostat, antimicrobial agent or added buffer and
each is intended only as a single-dose injection. When smaller doses are required
the unused portion should be discarded. The solutions
are parenteral fluid, nutrient and electrolyte replenishers. Dextrose,
USP is chemically designated D-glucose monohydrate (CHO���HO), a hexose sugar freely soluble in water. It has the following
structural formula: Sodium Chloride, USP is chemically
designated NaCl, a white crystalline powder freely soluble in water. Water
for Injection, USP is chemically designated H0. 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.
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When administered intravenously, these solutions provide
a source of water, carbohydrate and electrolytes. Solutions
which provide combinations of hypotonic or isotonic concentrations of dextrose
and of sodium chloride are suitable for parenteral maintenance or replacement
of water and electrolyte requirements with minimal carbohydrate calories. 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 injected
parenterally undergoes oxidation to carbon dioxide and water. Sodium
chloride in water dissociates to provide sodium (Na) and chloride
(Cl��) ions. Sodium (Na) is the principal cation of the extracellular
fluid and plays a large part in the therapy of fluid and electrolyte disturbances.
Chloride (Cl��) has an integral role in buffering action when oxygen and
carbon dioxide exchange occurs in the red blood cells. The distribution and
excretion of sodium (Na) and chloride (Cl��) are largely under
the control of the kidney which maintains a balance between intake and output. Water
is an essential constituent of all body tissues and accounts for approximately
70% of total body weight. Average normal adult daily requirements range 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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None known.
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| dailymed-instance:supply |
Dextrose and Sodium Chloride Injection, USP are supplied
in single-dose flexible plastic containers in various sizes and concentrations
as shown in the accompanying Table. Exposure of pharmaceutical products to heat should be minimized.
Avoid excessive heat. Protect from freezing. Store at 20 to 25��C (68
to 77��F). [See USP Controlled Room Temperature.] October, 2004 HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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| dailymed-instance:precautio... |
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. Solutions
containing dextrose should be used with caution in patients with known subclinical
or overt diabetes mellitus. Caution must be exercised
in the administration of parenteral fluids, especially those containing sodium
ions to patients receiving corticosteroids or corticotropin. 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 or sodium chloride. It is also not known whether dextrose or sodium
chloride can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. Dextrose or sodium chloride 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.<br/>Geriatric Use.: An evaluation of current literature revealed no clinical
experience identifying differences in response between 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 other drug therapy. Sodium ions are known to be substantially excreted
by the kidney, and the risk of toxic reactions may be greater in patients
with impaired renal function. Because elderly patients are more likely to
have decreased renal function, care should be taken in dose selection, and
it may be useful to monitor renal function.
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| dailymed-instance:overdosag... |
In the event of overhydration or solute overload, re-evaluate
the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS,
and ADVERSE REACTIONS.
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| dailymed-instance:genericMe... |
Dextrose monohydrate and Sodium Chloride
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| dailymed-instance:fullName |
Dextrose and Sodium Chloride (Injection, Solution)
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| dailymed-instance:adverseRe... |
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 |
Solutions containing sodium ions should be used with great
care, if at all, in patients with congestive heart failure, severe renal insufficiency
and in clinical states in which there exists edema with sodium retention. Excessive
administration of potassium-free solutions may result in significant hypokalemia. In
patients with diminished renal function, administration of solutions containing
sodium ions may result in sodium retention. 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. The risk of dilutional
states is inversely proportional to the electrolyte concentrations of administered
parenteral solutions. The risk of solute overload causing congested states
with peripheral and pulmonary edema is directly proportional to the electrolyte
concentrations of such solutions.
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| dailymed-instance:indicatio... |
Intravenous solutions containing dextrose and sodium chloride
are indicated for parenteral replenishment of fluid, minimal carbohydrate
calories, and sodium chloride as required by the clinical condition of the
patient.
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| dailymed-instance:name |
Dextrose and Sodium Chloride
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