Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/501
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Ionosol and Dextrose (Injection, Solution)
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dailymed-instance:dosage |
The dose is dependent upon the age, weight and clinical condition
of the patient. In infants, Ionosol MB and 5% Dextrose
Injection is given only after administration of an initial priming solution:
15 mL of half isotonic saline in 5% dextrose and 0.45% Sodium Chloride Injection/kg
of body weight, administered to small infants at a maximum rate of 0.8 mL/minute.
Infants typically tolerate not more than 150 to 200 mL of Ionosol MB and 5%
Dextrose Injection per kg body weight/day. 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. In
adults, intravenous infusions of Ionosol MB and 5% Dextrose Injection are
given postoperatively, at a rate not greater than 4 mL/minute. 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 To Administer WARNING: Do not use flexible container
in series connections.
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dailymed-instance:descripti... |
Ionosol MB and 5% Dextrose Injection (Multiple Electrolytes
and 5% Dextrose Injection Type 1, USP) is a sterile, nonpyrogenic solution
designed for intravenous administration. The solution is formulated to provide
fluid and electrolytes for treatment of dehydration and acidosis. Each
100 mL contains dextrose, hydrous 5 g; sodium lactate, anhydrous 260 mg; potassium
chloride 141 mg; magnesium chloride, hexahydrate 30 mg; monobasic potassium
phosphate, anhydrous 15 mg; and monobasic sodium phosphate, monohydrate 25
mg. Each liter contains 25 mEq sodium (Na);
20 mEq potassium (K); 3 mEq magnesium (Mg); 22 mEq
chloride (Cl��); 3 mM of phosphate (PO���); and 23 mEq
lactate (CHCH(OH)COO��). The electrolyte
content is hypotonic (100 mOsmol/L) in relation to the extracellular fluid
(approx. 280 mOsmol/L). The osmolarity for the total solution is 352 mOsmol/L
(calc.). May contain hydrochloric acid for pH adjustment. pH is 5.0 (4.0 to
6.5). 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: Magnesium
Chloride, USP, hexahydrate is chemically designated MgCl���6HO, colorless flakes or crystals very soluble in water. Potassium
Chloride, USP is chemically designated KCl, a white granular powder freely
soluble in water. Monobasic Potassium Phosphate, NF,
anhydrous is chemically designated KHPO, colorless
crystals or white granular powder freely soluble in water. Sodium
Lactate, USP is chemically designated CHCH(OH)COONa, a 60% aqueous
solution miscible 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 theplastic has been confirmed by tests in animals according to
USP biological standards for plastic containers.
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dailymed-instance:clinicalP... |
Ionosol MB and 5% Dextrose Injection contains a hypotonic
concentration of electrolytes with dextrose. The letters���MB���mean���modified Butler's���solution; the modified solution
contains 5 mEq less sodium, 5 mEq more potassium, and 3 mEq added magnesium,
as compared with the original Butler's solution. The modified solution
can be used in pediatric patients for treatment of dehydration, acidosis,
diarrhea, or burns, and in adults for postoperative fluid and electrolyte
therapy. Solutions containing 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 with shock 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. 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. 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 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 resultingin potassium depletion. 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. Ionosol MB 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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dailymed-instance:supply |
Ionosol MB and 5% Dextrose Injection (Multiple Electrolytes
and 5% Dextrose Injection Type 1, USP) is supplied in 250, 500, and 1000 mL
flexible plastic single-dose containers, List No. 7372. 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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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 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.<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.
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dailymed-instance:overdosag... |
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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dailymed-instance:genericMe... |
Sodium lactate, potassium chloride, magnesium chloride, potassium phosphate, sodium phosphate and dextrose
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dailymed-instance:fullName |
Ionosol 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 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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dailymed-instance:warning |
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. In
patients 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 MB 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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dailymed-instance:indicatio... |
Ionosol MB and 5% Dextrose Injection is indicated for intravenous
administration to infants for treatment of dehydration, acidosis, diarrhea,
and burns, but only after administration of an initial priming solution: 15
mL of 5% dextrose and 0.45% Sodium Chloride Injection/kg of body weight. In
adults, Ionosol MB and 5% Dextrose Injection is indicated postoperatively
for intravenous fluid and electrolyte maintenance therapy, with a small amount
of carbohydrate calories for reducing catabolism of endogenous protein reserves.
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dailymed-instance:name |
Ionosol and Dextrose
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