Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1894
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Ionosol and Dextrose (Injection, Solution)
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The dose is dependent upon the age, weight and clinical condition
of the patient. 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 and discoloration prior
to administration. 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 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 Preparation for Administration (Use Aseptic Technique) WARNING: Do not use flexible container
in series connections.
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Ionosol T and 5% Dextrose Injection (Multiple Electrolytes
and 5% Dextrose Injection Type 3, USP) is a sterile, nonpyrogenic fluid electrolyte
replenisher and nutrient for intravenous administration. Each
100 mL contains dextrose, hydrous 5 g; sodium chloride 146 mg; potassium chloride
111 mg; potassium lactate, anhydrous 256 mg; monobasic sodium phosphate,
monohydrate 207 mg. The pH is 5.0 (4.0 to 6.5); the osmolarity (calc.)
is 432 mOsmol/L. Each liter contains sodium, 40 mEq; potassium, 35 mEq; chloride,
40 mEq;phosphate (PO), 15 mM; and lactate,
20 mEq. Dextrose, USP, hydrous is chemically designated
CHO���HO (D-glucose,
monohydrate), a hexose sugar freely soluble in water. Dextrose, hydrous has
the following structural formula: Potassium
Chloride, USP is chemically designated KCl, a white granular powder freely
soluble in water. Potassium lactate, anhydrous is chemically
designated CHCH(OH)COOK, a thick liquid miscible in water. Sodium
Chloride, USP is chemically designated NaCl, a white crystalline compound
freely soluble in water. Monobasic Sodium Phosphate,
USP, monohydrate is chemically designated NaHPO���HO, white crystals or granules freely soluble in water. Water
for Injection, USP is chemically designated HO. 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 inside
the plastic container also can leach out certain of their chemical components
in very small amounts before the expiration period is attained. However, the
safety of the plastic has been confirmed by tests in animals according to
USP biological standards for plastic containers.
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When administered intravenously, Ionosol T and 5% Dextrose
Injection provides a source of water, electrolytes, and carbohydrate. The
solution was originally designed as a pediatric fluid/electrolyte replacement
formula, providing nearly equal amounts of sodium, potassium, and chloride;
phosphate and lactate are also present, along with dextrose. 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. The
lactate anion provides an alkalizing effect resulting from simultaneous removal
by the liver of lactate and hydrogen ions. In the liver, the lactate is metabolized
to glycogen which is ultimately converted to carbon dioxide and water by oxidative
metabolism. The lactate anion acts as a source (alternate)
of bicarbonate when normal production and utilization of lactic acid is not
impaired as a result of disordered lactate metabolism. Since metabolic conversion
is dependent on the integrity of cellular oxidative processes, lactate may
be inadequate or ineffective as a source of bicarbonate in patients suffering
from acidosis associated withshock or other disorders involving reduced perfusion
of body tissues. When oxidative activity is intact, one to two hours time
is required for metabolism of lactate. Phosphate is
one of the three major intracellular electrolytes (along with potassium and
magnesium) and the largest anion component found within the cells. Its concentration
and excretion are largely dependent on intake, acid-base balance and endocrine
function. Its metabolism follows that of calcium in many respects. Phosphate
anion in electrolyte solutions may help to repair phosphate deficiency. 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).
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. 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 requirement ranges 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. Ionosol
T and 5% Dextrose Injection contains a hypotonic electrolyte concentration.
This should not be confused with the total tonicity (electrolytes plus nonelectrolytes)
of solutions containing both electrolytes and dextrose. In general, solutions
providing isotonic electrolyte concentrations are most applicable to replacement
of acute deficits, whereas hypotonic electrolyte concentrations are best suited
for parenteral maintenance of water requirements when only small quantities
of electrolytes are desired.
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Solutions containing potassium are contraindicated in diseases
where high potassium levels may be encountered.
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Ionosol T and 5% Dextrose Injection (Multiple Electrolytes
and 5% Dextrose Injection Type 3, USP) is supplied in flexible plastic containers
providing 500 and 1000 mL fluid volumes (List No. 7373). 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); however, brief exposure up to 40��C does not
adversely affect the product. HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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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 lactate 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
Ionosol solutions. It is also not known whether Ionosol solutions can cause
fetal harm when administered to a pregnant woman or can affect reproduction
capacity. Ionosol solutions should be given to a pregnant woman only if clearly
needed.<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. This drug is 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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In the event of overhydration or solute overload during therapy,
re-evaluate the patient and institute appropriate corrective measures. See
WARNINGS and PRECAUTIONS.
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Sodium chloride, potassium chloride, potassium lactate, sodium phosphate and dextrose
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Ionosol 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 which contain potassium ions 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. 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. Inpatients with diminished renal function, administration of solutions containing
sodium or potassium ions may result in sodium or potassium retention. Solutions
containing lactate ions should be used with great care, if at all, in patients
with metabolic or respiratory alkalosis. The administration of lactate ions
should be done with great care in those conditions in which there is an increased
level or an impaired utilization of lactate ions, such as severe hepatic insufficiency. The
intravenous administration of Ionosol T and 5% Dextrose Injection 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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Ionosol T and 5% Dextrose Injection is used to provide water,
carbohydrate, and electrolytes to cover hydration, insensible water losses
and urinary excretion. The electrolyte content of the solution is hypotonic,
but the tonicity of the total solution is hypertonic.
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Ionosol and Dextrose
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