Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3576
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Potassium Chloride in Dextrose and Sodium Chloride (Injection, Solution)
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These solutions should be administered only by intravenous
infusion and as directed by the physician. The dose and rate of injection
are dependent upon the age, weight and clinical condition of the patient.
If the serum potassium level is greater than 2.5 mEq/liter, potassium should
be given at a rate not to exceed 10 mEq/hour in a concentration less than
30 mEq/liter. Somewhat faster rates and greater concentrations (usually up
to 40 mEq/liter) of potassium may be indicated in patients with more severe
potassium deficiency. The total 24-hour dose should not generally exceed 200 mEq
of potassium. 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.<br/>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,
whenever solution and container permit. See PRECAUTIONS.
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Intravenous solutions with potassium chloride
(I.V. solutions with KCl) are sterile and nonpyrogenic solutions in water
for injection. They are for administration by intravenous infusion only. See
Tables for summary of content and characteristics of these solutions. The
solutions contain no bacteriostat, antimicrobial agent or added buffer and
each is intended only for use as a single-dose injection. When smaller doses
are required the unused portion should be discarded. These
solutions are parenteral fluid, nutrient and/or electrolyte replenishers. Dextrose,
USP is chemically designated D-glucose, monohydrate (CHO���HO), a hexose sugar freely soluble in water. It has the following
structural formula: Potassium Chloride, USP is chemically
designated KCl, a white granular powder freely soluble in water. Sodium
Chloride, USP is chemically designated NaCl, a white crystalline powder 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 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 the 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, these solutions provide
a source of water and potassium chloride with carbohydrate (dextrose) and
sodium chloride. See HOW SUPPLIED section for specific concentrations of these
various solutions. 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. Intravenous
solutions containing potassium chloride are particularly intended to provide
needed potassium cation (K). 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.
A deficiency of either potassium or chloride will lead to a deficit of the
other. 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.
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Solutions containing potassium chloride are contraindicated
in diseases where high potassium levels may be encountered.
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Intravenous solutions with potassium chloride (I.V. solution
with KCl) are supplied in single-dose flexible plastic containers. See Tables: May contain HCl for pH adjustment. 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. Solutions
containing dextrose should be used with caution in patients with known subclinical
or overt diabetes mellitus. Caution must be exercised
in the administration of parenteral fluids, especially those containing sodium
ions, to patients receiving corticosteroids or corticotropin. Potassium
replacement therapy should be guided primarily by serial electrocardiograms.
Plasma potassium levels are not necessarily indicative of tissue potassium
levels. High plasma concentrations of potassium may
cause death through cardiac depression, arrhythmias or arrest. Potassium-containing
solutions should be used with caution in the presence of cardiac disease,
particularly in digitalized patients or in the presence of renal disease. Care
should be exercised to insure that the needle (or catheter) is well within
the lumen of the vein and that extravasation does not occur. Do
not administer unless solution is clear and container is undamaged. Discard
unused portion.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Studies with solutions from flexible plastic containers have
not been performed to evaluate carcinogenic potential, mutagenic potential
or effects on fertility.<br/>Pregnancy Category C.: Animal reproduction studies have not been conducted with
dextrose, potassium chloride or sodium chloride. It is also not known whether
dextrose, potassium chloride or sodium chloride can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity. Dextrose,
potassium chloride or sodium chloride should be given to a pregnant woman
only if clearly needed.<br/>Nursing Mothers:: Caution should be exercised when solutions from flexible
plastic containers are administered to a nursing mother.<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.<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. Sodium and potassium ions are 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 potassium overdosage, discontinue the infusion
immediately and institute intensive corrective therapy to reduce serum potassium
levels. See WARNINGS and PRECAUTIONS.
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Potassium Chloride, Dextrose and Sodium Chloride
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Potassium Chloride in Dextrose and Sodium Chloride (Injection, Solution)
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| dailymed-instance:adverseRe... |
Reactions which may occur because of the solutions or 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. Nausea, vomiting, abdominal pain and diarrhea
have been reported with potassium therapy. The signs and symptoms of potassium
intoxication include paresthesias of the extremities, flaccid paralysis, listlessness,
mental confusion, weakness and heaviness of the legs, hypotension, cardiac
arrhythmias, heart block, electrocardiographic abnormalities such as disappearance
of P waves, spreading and slurring of the QRS complex with development of
a biphasic curve and cardiac arrest. Potassium-containing
solutions are intrinsically irritating to tissues. Therefore, extreme care
should be taken to avoid perivascular infiltration. Local tissue necrosis
and subsequent sloughing may result if extravasation occurs. Chemical phlebitis
and venospasm have also been reported. Should perivascular
infiltration occur, I.V. administration at that site should be discontinued
at once. Local infiltration of the affected area with procaine hydrochloride,
1%, to which hyaluronidase may be added, will often reduce venospasm and dilute
the potassium remaining in the tissues locally. Local application of heat
may also be helpful.
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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. To
avoid potassium intoxication, do not infuse these solutions rapidly. In patients
with severe renal insufficiency or adrenal insufficiency, administration of
potassium chloride may cause potassium intoxication. 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. The
intravenous administration of these solutions 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 concentration 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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These solutions are indicated in patients requiring parenteral
administration of potassium chloride with minimal carbohydrate calories and
sodium chloride.
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Potassium Chloride in Dextrose and Sodium Chloride
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