Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1961
Predicate | Object |
---|---|
rdf:type | |
rdfs:label |
Ionosol and Dextrose (Injection, Solution)
|
dailymed-instance:dosage |
The dose is dependent upon the age, weight and clinical condition
of the patient. The nominal dosage level for adults is 30 mL/kg. Ionosol B
and 5% Dextrose Injection is administered intravenously. 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. 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 1. Prepare additive port. 2.
Using aseptic technique and an additive delivery needle of appropriate length,
puncture resealable additive port at target area, inner diaphragm and inject.
Withdraw needle after injecting medication. 3. The
additive port may be protected by covering with an additive cap. 4.
Mix container contents thoroughly. To
Administer 1. Attach administration set per
manufacturer's instructions. 2. Regulate rate
of administration per institutional policy. WARNING: Do not use flexible container in series connections.
|
dailymed-instance:descripti... |
Ionosol B 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 meet
maintenance requirements for fluid and electrolytes. Each
100 mL contains dextrose, hydrous 5 g plus sodium chloride 180 mg; potassium
chloride 100 mg; sodium lactate, anhydrous 280 mg; magnesium chloride, hexahydrate
53 mg; dibasic potassium phosphate, anhydrous 100 mg; and monobasic sodium
phosphate, monohydrate 16 mg. Each liter contains 57
mEq sodium (Na); 25 mEq potassium (K); 5 mEq magnesium
(Mg); 49 mEq chloride (Cl); 7 mM phosphate (PO); and 25 mEq lactate
(CHCH(OH)COO). The electrolyte
content is hypotonic (174 mOsmol/L, calc.) in relation to the extracellular
fluid (approx. 280 mOsmol/L). The osmolarity for the total solution is 426
mOsmol/L (calc.). May contain hydrochloric acid and/or sodium hydroxide 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. Dibasic Potassium Phosphate, USP,
anhydrous is chemically designated KHPO, white granules
very soluble in water. Sodium Chloride, USP is chemically
designated NaCl, a white crystalline compound 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 the plastic has been confirmed by tests in animals according to
USP biological standards for plastic containers.
|
dailymed-instance:clinicalP... |
Ionosol B and 5% Dextrose Injection contains a hypotonic
concentration of electrolytes with dextrose. The original formulation was
Butler's solution, and provides the major intracellular electrolytes
(potassium, magnesium, and phosphorus) as well as sodium and chloride. The
formula is intended as an intravenous maintenance solution which at 30 mL/kg
meets adult maintenance requirements for water and electrolytes. The solution
can also be used to replace fluid loss from the large intestine. 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 helpto 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 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). 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 B 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.
|
dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
Solutions containing potassium are contraindicated in diseases
where high potassium levels may be encountered.
|
dailymed-instance:supply |
Ionosol B and 5% Dextrose Injection (Multiple Electrolytes
and 5% Dextrose Injection Type 1, USP) is supplied in 500 and 1000 mL flexible
plastic single-dose containers, List No. 7371. 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
|
dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
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. The 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.
|
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.
|
dailymed-instance:genericMe... |
Sodium chloride, potassium chloride, sodium lactate, magnesium chloride, potassium phosphate, sodium phosphate and Dextrose
|
dailymed-instance:fullName |
Ionosol and Dextrose (Injection, Solution)
|
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.
|
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 B 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.
|
dailymed-instance:indicatio... |
Ionosol B and 5% Dextrose Injection is indicated for intravenous
administration to patients who require a maintenance source of fluid and electrolytes. Ionosol
B and 5% Dextrose Injection is used in patients requiring polyionic fluid
maintenance, for alkalosis due to vomiting, diabetic acidosis, fluid losses
due to burns or stress and postoperative dehydration.
|
dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Ionosol and Dextrose
|