Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1601
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Potassium Chloride in Dextrose (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 notgenerally 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. Parenteral
drug products should be inspected visually for particulate matter and discoloration
prior to administration, whenever solution and container permit. See PRECAUTIONS. Drug
Interactions Additives may be incompatible. Consult
with pharmacist, if available. When introducing additives, use aseptic technique,
mix thoroughly and do not store.
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Potassium Chloride in Dextrose Injection, USP are sterile
and nonpyrogenic solutions in water for injection. They are for administration
by intravenous infusion only. See Table 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 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. 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, these solutions provide
a source of water and potassium chloride with carbohydrate. 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. 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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Potassium Chloride in Dextrose Injection, USP solutions are
supplied in single-dose flexible plastic containers. See Table: 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. Covered by one or more
of the following U.S. patents: 4,368,765; 4,344,472. 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/>Pregnancy Category C.: Animal reproduction studies have not been conducted with
dextrose or potassium chloride. It is also not known whether dextrose or potassium
chloride can cause fetal harm when administered to a pregnant woman or can
affect reproduction capacity. Dextrose or potassium chloride should be given
to a pregnant woman only if clearly needed.<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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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 and Dextrose
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Potassium Chloride in Dextrose (Injection, Solution)
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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. In
patients with diminished renal function, administration of solutions containing
potassium ions may result in 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.
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Potassium Chloride in Dextrose
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