Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/825
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Normosol-R (Injection, Solution)
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Normosol-R pH 7.4 is administered by intravenous infusion.
It may also be administered subcutaneously. The amount to be infused is based
on replacement of losses of extracellular fluid volume in the individual patient.
Up to three 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. 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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Normosol-R pH 7.4 is a sterile, nonpyrogenic,
isotonic solution of balanced electrolytes in water for injection. The solution
is administered by intravenous infusion for parenteral replacement of acute
losses of extracellular fluid. Each 100 mL of Normosol-R
pH 7.4 contains sodium chloride, 526 mg; sodium acetate, 222 mg; sodium
gluconate, 502 mg; potassium chloride, 37 mg; magnesium chloride, hexahydrate
30 mg. May contain hydrochloric acid and/or sodium hydroxide for pH adjustment.
pH range 6.5 to 7.6; 295 mOsmol/liter (calc.). Electrolytes
per 1000 mL (not including pH adjustment): Sodium 140 mEq; potassium 5 mEq;
magnesium 3 mEq; chloride 98 mEq; acetate 27 mEq; gluconate 23 mEq. 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
pH 7.4 is a parenteral fluid and electrolyte replenisher. 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���6HO)
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 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.
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When administered intravenously, Normosol-R pH 7.4 provides
water and electrolytes 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. 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 (CHO)
ions. Although gluconate is a theoretical alternate metabolic source of bicarbonate
(HCO) anion, a significant antiacidotic action
has not been established. Thus, the gluconate anion serves primarily to complete
the cation-anion balance of the solutions. 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 pH 7.4 (Multiple Electrolytes Injection Type 1,
USP) is supplied in 500 and 1000 mL single-dose flexible plastic containers
(List No. 7670). 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 U.S. patents: 4,344,472; 4,368,765. March, 2004 ��Hospira 2004 EN-0014 Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA
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Normosol-R pH 7.4 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 pH 7.4 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. 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 pH 7.4. 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 of Normosol-R pH 7.4 have been
established in the age groups of birth to 16 years. Use of Normosol-R pH 7.4
is supported by evidence from adequate and well-controlled clinical studies
in adults with additional data from post-marketing experience in the pediatric
population.<br/>Geriatric Use:: Clinical studies of Normosol-R 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, usuallystarting
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 monitor renal function. See WARNINGS.<br/>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 pH 7.4 does not contain
calcium to avoid precipitation of calcium salts that may occur when certain
drugs are added. Solutions which contain calcium in amounts exceeding the
normal plasma concentration may enhance clotting on contact with citrated
blood. Hence, Normosol-R pH 7.4 can be used for starting a blood transfusion.
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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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Sodium Chloride, Sodium Acetate, Sodium Gluconate, Potassium Chloride and Magnesium Chloride
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Normosol-R (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. 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 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 pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma,
burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore
a decrease in circulatory volume in patients with moderate blood loss. Normosol-R
pH 7.4 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. Normosol-R pH 7.4 is particularly valuable
as a solution for use in starting blood, i.e., as a priming solution for the
infusion set. No hemolysis of blood is seen at the interface or with mixed
solution and blood. It may also be used as a diluent to aid in the transfusion
of packed red blood cells (PRBC). Normosol-R pH 7.4 and physiologic saline
solution (0.9% Sodium Chloride Injection, USP) are compatible with both young
and old PRBC.
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Normosol-R
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