Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1938
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Normosol-M and Dextrose (Injection, Solution)
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Normosol-M and 5% Dextrose Injection is administered by intravenous
infusion. The dose is dependent upon the age, weight and clinical condition
of the patient. A daily total amount of 1500 mL/Mof body surface
will meet the usual adult daily requirements for water and principal electrolytes
in patients unable to take anything by mouth. The usual daily maintenance
amount for an average adult (70 kg and 1.8 square meters of body surface)
is approximately three liters. 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. To
avoid precipitation of calcium salts that may occur when certain drugs are
added, Normosol-M and 5% Dextrose Injection does not contain calcium. 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. The opacity will diminish
gradually. 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-M and 5% Dextrose Injection (Multiple Electrolytes
and 5% Dextrose Injection Type 1, USP) is a sterile, nonpyrogenic, hypertonic
solution of balanced maintenance electrolytes and 5% dextrose injection in
water for injection. The solution is administered by
intravenous infusion for parenteral maintenance of routine daily fluid and
electrolyte requirements with minimal carbohydrate calories. Each
100 mL contains dextrose, hydrous 5 g, sodium chloride, 234 mg, potassium
acetate, 128 mg and magnesium acetate, anhydrous 21 mg. May contain hydrochloric
acid for pH adjustment. The electrolyte content (not including hydrochloric
acid) and other characteristics are as follows: 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-M and 5% Dextrose Injection
is a parenteral fluid, electrolyte 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: Sodium Chloride, USP is chemically
designated NaCl, a white crystalline powder freely soluble in water. Potassium
Acetate, USP is chemically designated CHCOOK, colorless crystals
or white crystalline powder very soluble in water. Magnesium
acetate is chemically designated Mg (CHO),
colorless or white crystals very soluble in water. Water
for Injection, USP is chemically designated HO. The
flexible plastic container is fabricated from a specially formulated polyvinyl
chloride. 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. ������������������������������������������������������������������ 'Normosol������multiple electrolyte solutions,
Hospira.
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| dailymed-instance:clinicalP... |
When administered intravenously, Normosol-M and 5% Dextrose
Injection provides water and electrolytes (with dextrose as a readily available
source of carbohydrate) for maintenance of daily fluid and electrolyte requirements,
plus minimal carbohydrate calories. The electrolyte composition approaches
that of the principal ions of normal plasma (extracellular fluid). The electrolyte
concentration is hypotonic (112 mOsmol/liter) in relation to the extracellular
fluid (280 mOsmol/liter). One liter provides approximately one-third of theaverage adult daily requirement for water and principal electrolytes in balanced
proportions, with acetate as a bicarbonate alternate, plus 170 calories from
dextrose. 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 in 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 acetate in water dissociates
to provide potassium (K) and acetate (CHCOO)
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
acetate in water dissociates to provide magnesium (Mg) and acetate
(CHCOO) 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. Acetate
anion (CHCOO), a source of hydrogen ion acceptors,
serves 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. 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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| dailymed-instance:supply |
Normosol-M and 5% Dextrose Injection (Multiple Electrolytes
and 5% Dextrose Injection Type 1, USP) is supplied in single-dose 500 and
1000 mL flexible plastic containers (List No. 7965). Exposure
of pharmaceutical products to heat should be minimized. Store at 20 to 25��C(68
to 77��F). [See USP Controlled Room Temperature.] Covered by one or more
of the following patents: 4,344,472; 4,368,765. November, 2004 ��Hospira 2004 EN-0708 Printed in
USA 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. Caution
must be exercised in the administration of parenteral fluids, especially those
containing sodium ions, to patients receiving corticosteroids or corticotropin. Solutions
containing acetate 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. In
very low birth weight infants, excessive or rapid administration of dextrose
injection may result in increased serum osmolality and possible intracerebral
hemorrhage.<br/>Pregnancy Category C.: Animal reproduction studies have not been conducted with
Normosol-M 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 and 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.
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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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| dailymed-instance:genericMe... |
Dextrose, Sodium Chloride, Potassium Acetate and Magnesium Acetate
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Normosol-M and Dextrose (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 reactiondoes 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. 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. Solutions
containing acetate should be used with great care in patients with metabolic
or respiratory alkalosis, and in those conditions in which there is an increased
level or an impaired utilization of acetate, such as severe hepatic insufficiency. Administration
of this solution 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... |
Normosol-M and 5% Dextrose Injection (Multiple Electrolytes
and 5% Dextrose Injection Type 1, USP) is indicated for parenteral maintenance
of routine daily fluid and electrolyte requirements with minimal carbohydrate
calories from dextrose. Magnesium in the formula may help to prevent iatrogenic
magnesium deficiency in patients receiving prolonged parenteral therapy.
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| dailymed-instance:name |
Normosol-M and Dextrose
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