Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1238
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Normosol-R and Dextrose (Injection, Solution)
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Normosol-R and 5% Dextrose Injection is administered by intravenous
infusion. The amount to be infused is based on replacement of losses of extracellular
fluid volume in the individual patient. Up to 3 times the volume of estimated
blood loss during and after surgery can be given to correct circulatory volume
when there is only a moderate loss of blood. 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. Drug Interactions Additives
may be incompatible. Consult with pharmacist, if available. When introducing
additives, use aseptic technique, mix thoroughly and do not store. Normosol-R
and 5% Dextrose solution does not contain calcium to avoid precipitation of
calcium salts that may occur when certain drugs are added. Parenteral
drug products should be inspected visually for particulate matter or discoloration
prior to administration, whenever solution and container permit. See PRECAUTIONS. INSTRUCTIONS FOR USE To Open: Tear outer wrap
at notch and remove solution container. Some opacity of the plastic due to
moisture absorption during the sterilization process may be observed. This
is normal and does not affect the solution quality or safety. If supplemental
medication is desired, follow directions below before preparing for administration. To Add Medication To Administer WARNING: Do not use flexible container
in series connections.
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| dailymed-instance:descripti... |
Normosol-R and 5% Dextrose Injection is a sterile, nonpyrogenic
solution of balanced electrolytes (with dextrose) in water for injection.
The solution is administered by intravenous infusion for parenteral replacement
of acute losses of extracellular fluid (with minimal carbohydrate calories). Each
100 mL of Normosol-R and 5% Dextrose Injection contains dextrose 5 g; sodium
chloride 526 mg; sodium acetate, anhydrous 222 mg; sodium gluconate 502 mg;
potassium chloride 37 mg; magnesium chloride, hexahydrate 30 mg; pH adjusted
with hydrochloric acid. See TABLE for summary of electrolyte
content, caloric value and characteristics of this solution. The
solution contains no bacteriostat, antimicrobial agent or added buffer (except
for pH adjustment) and is intended only for use as a single-dose injection.
When smaller doses are required the unused portion should be discarded. Normosol-R
and 5% Dextrose Injection is a parenteral fluid, electrolyte and nutrient
replenisher. Dextrose, USP is chemically designated
D-glucose monohydrate (CHO���H0), 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. Potassium
Chloride, USP is chemically designated KCl, a white granular powder freely
soluble in water. Magnesium Chloride, USP is chemically
designated magnesium chloride hexahydrate (MgCl���6H0) deliquescent
crystals very soluble in water. Sodium Acetate, USP,
is chemically designated sodium acetate anhydrous (CHNaO),
a hygroscopic powder soluble in water. It has the following structural formula: Sodium
gluconate is chemically designated CHNaO,
the normal sodium salt of gluconic acid soluble in water. It has the following
structural formula: 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, Normosol-R and 5% Dextrose
Injection provides water and electrolytes with carbohydrate calories for replacement
of acute extracellular fluid losses without disturbing normal electrolyte
relationships. The electrolyte composition approaches that of the principal
ions of normal plasma (extracellular fluid). The electrolyte concentration
is approximately isotonic in relation to the extracellular fluid (approx.
280 mOsmol/liter) and provides a physiologic sodium to chloride ratio, normal
plasma concentrations of potassium and magnesium and two bicarbonate alternates,
acetate and gluconate. Dextrose provides minimal calories and renders the
solution hypertonic. Solutions containing carbohydrate
in the form of dextrose restore blood glucose levels and supply 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. Potassium
chloride in water dissociates to provide potassium (K) and chloride
(Cl) ions. Potassium is the chief cation of body cells (160 mEq/liter
of intracellular water). It is found in low concentration in plasma and extracellular
fluids (3.5 to 5.0 mEq/liter in a healthy adult and child over 10 days old;
3.5 to 6.0 mEq/liter in a child less than 10 days old). Potassium plays an
important role in electrolyte balance. Normally about
80 to 90% of the potassium intake is excreted in the urine; the remainder
in the stools and to a small extent, in the perspiration. The kidney does
not conserve potassium well so that during fasting or in patients on a potassium-free
diet, potassium loss from the body continues resulting in potassium depletion. Magnesium
chloride in water dissociates to provide magnesium (Mg) and chloride
(Cl���) ions. Magnesium is the second most plentiful cation of the intracellular
fluids. It is an important cofactor for enzymatic reactions and plays an important
role in neurochemical transmission and muscular excitability. Normal plasma
concentration ranges from 1.5 to 2.5 or 3.0 mEq per liter. Magnesium is excreted
solely by the kidney at a rate proportional to the plasma concentration and
glomerular filtration. Sodium acetate provides sodium
(Na) and acetate (CHCOO���) ions, the latter
anion (a source of hydrogen ion acceptors) serving as an alternate source
of bicarbonate (HCO���) by metabolic conversion in the liver.
This has been shown to proceed readily even in the presence of severe liver
disease. Thus, acetate anion exerts a mild systemic antiacidotic action that
may be advantageous during fluid and electrolyte replacement therapy. Sodium
gluconate provides sodium (Na) and gluconate (CH���)
ions. Although gluconate is a theoretical alternate metabolic source of bicarbonate
(HC0���) anion, a significant antiacidotic action has not
been established. Thus, the gluconate anion serves primarily to complete the
cation-anion balance of the solution. 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). Average normal pediatric daily
requirements are based on the child's weight as described in the table
below: 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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Normosol-R and 5% Dextrose Injection (Multiple
Electrolytes and 5% Dextrose Injection Type 1, USP) is supplied in a 1000
mL single-dose flexible plastic container (List No. 7968). * Normosol-R and 5% Dextrose calories
derived from dextrose (170) and gluconate (15). **Not
including hydrochloric acid. Exposure of pharmaceutical
products to heat should be minimized. Avoid excessive heat. Protect from freezing.
It is recommended that the product be stored at room temperature (25��C/77��F). Covered
by one or more of the following US patents: 4,368,765; 4,344,472. 'Normosol���multiple electrolyte solution, Hospira October, 2004 ��Hospira 2004 EN-0500 Printed in
USA HOSPIRA, INC., LAKE
FOREST, IL 60045 USA
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Normosol-R and 5% Dextrose Injection should be used with
caution in severe renal impairment because of the danger of hyperkalemia.
As with all intravenous solutions, care should be taken to avoid circulatory
overload, especially in patients with cardiac or pulmonary disorders. Normosol-R
and 5% Dextrose is not intended to correct acidosis or large deficits of individual
electrolytes, nor to replace blood or plasma expanders when these are indicated. 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. Caution must be exercised
in the administration of parenteral fluids, especially those containing sodium
ions, to patients receiving corticosteroids or corticotropin. Solutions
containing acetate or gluconate ions should be used with caution, as excess
administration may result in metabolic alkalosis. Solutions
containing dextrose should be used with caution in patients with known subclinical
or overt diabetes mellitus. 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 Normosol-R
and 5% Dextrose Injection. It is also not known whether this solution can
cause fetal harm when administered to a pregnant woman or can affect reproduction
capacity. This solution 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:: Clinical studies of Normosol-R and 5% Dextrose did not include
sufficient numbers of subjects aged 65 and over to determine whether they
respond differently from younger subjects. Other reported clinical experience
has not identified 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. Elderly patients have been shown
to secrete higher levels of antidiuretic hormone than younger patients, which
may increase the risk of fluid overloading, and dilutional hyponatremia in
these patients. See WARNINGS. This drug is known to
be substantially excreted by the kidney, and the risk of toxic reactions to
this drug 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 monitorrenal function.
See WARNINGS.
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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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Dextrose, sodium chloride, sodium acetate, sodium gluconate, potassium chloride, and magnesium chloride
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Normosol-R and Dextrose (Injection, Solution)
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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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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. Solutions
which contain potassium should be used with great care, if at all, in patients
with hyperkalemia, severe renal failure and in conditions in which potassium
retention is present. In patients with diminished renal
function, administration of solutions containing sodium or potassium ions
may result in sodium or potassium retention. 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 during fluid replacement
with Normosol-R and 5% Dextrose. Solutions containing
acetate or gluconate ions should be used with great care in patients with
metabolic or respiratory alkalosis. Acetate or gluconate should be administered
with great care in those conditions in which there is an increased level or
an impaired utilization of these ions, such as severe hepatic insufficiency. The
intravenous administration of this solution can cause fluid and/or solute
overloading resulting in dilution of serum electrolyte concentrations, overhydration,
congested states or pulmonary edema. Elderly patients
may be at increased risk for the development of fluid overloading and dilutional
hyponatremia following Normosol-R and 5% Dextrose administration. 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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Normosol-R and 5% Dextrose Injection is indicated for replacement of acute extracellular fluid volume
losses in surgery, trauma, burns or shock. Normosol-R and 5% Dextrose also
can be used as an adjunct to restore a decrease in circulatory volume in patients
with moderate blood loss. The solution is not intended to supplant transfusion
of whole blood or packed red cells in the presence of uncontrolled hemorrhage
or severe reductions of red cell volume.
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Normosol-R and Dextrose
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