Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3345
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Normosol-R (Injection, Solution)
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Normosol-R 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 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. Drug Interactions Additives may be incompatible. Consult with
pharmacist, if available. When introducing additives, use aseptic technique,
mix thoroughly and do not store. Parenteral drug products
should be inspected visually for particulate matter or discoloration prior
to administration, whenever solution and container permit. See PRECAUTIONS. Normosol-Rdoes 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 can be used for starting blood transfusion. 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 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 contains sodium chloride,
526 mg; sodium acetate, 222 mg; sodium gluconate, 502 mg; potassium chloride,
37 mg; magnesium chloride hexahydrate, 30 mg. May contain HCl and/or NaOH
for pH adjustment. pH 6.6 (4.0 to 8.0); 294 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
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 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/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 (Multiple Electrolytes Injection Type 1, USP)
is supplied in 500 and 1000 mL single-dose flexible plastic containers (List
No. 7967). 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: 4,368,765; 4,344,472. April, 2004 ��Hospira 2004 EN-0068 Printed in USA HOSPIRA, INC., LAKE FOREST, IL 60045 USA
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Normosol-R 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 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. 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 have been established
in the age groups of birth to 16 years. Use of Normosol-R 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, 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 monitor renal 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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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 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma,
burns or shock. Normosol-R also can be used as an adjunct to restore a decrease
in circulatory volume in patients with moderate blood loss. Normosol-R 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
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