Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3389
| Predicate | Object |
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| rdf:type | |
| rdfs:label |
Potassium chloride, dextrose and sodium chloride (Injection, Solution)
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| dailymed-instance:dosage |
As directed by a
physician. Dosage is dependent upon the age, weight and clinical
condition of the patient as well as laboratory determinations. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. Use of a final filter is recommended during administration of
all parenteral solutions, where possible. All injections in
VIAFLEX Plus plastic containers are intended for intravenous
administration using sterile equipment. Additives may be
incompatible. Complete information is not available. Those additives
known to be incompatible should not be used. Consult with pharmacist, if
available. If, in the informed judgment of the physician, it is deemed
advisable to introduce additives, use aseptic technique. Mix thoroughly
when additives have been introduced. Do not store solutions containing
additives.
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| dailymed-instance:descripti... |
Potassium Chloride
in 5% Dextrose and Sodium Chloride Injection, USP is a sterile,
nonpyrogenic solution for fluid and electrolyte replenishment and
caloric supply in a single dose container for intravenous
administration. It contains no antimicrobial agents. Composition,
osmolarity, pH, ionic concentration and caloric content are shown in
Table 1. The VIAFLEX Plus
plastic container is fabricated from a specially formulated polyvinyl
chloride (PL 146 Plastic). VIAFLEX Plus on the container indicates the
presence of a drug additive in a drug vehicle. The VIAFLEX Plus plastic
container system utilizes the same container as the VIAFLEX plastic
container system. The amount of water that can permeate from inside the
container into the overwrap is insufficient to affect the solution
significantly. Solutions in contact with the plastic container can leach
out certain of its chemical components in very small amounts within the
expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts
per million. However, the safety of the plastic has been confirmed in
tests in animals according to USP biological tests for plastic
containers as well as by tissue culture toxicity studies.
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| dailymed-instance:clinicalP... |
Potassium Chloride
in 5% Dextrose and Sodium Chloride Injection, USP has value as a source
of water, electrolytes and calories. It is capable of inducing diuresis
depending on the clinical condition of the patient.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
Solutions
containing dextrose may be contraindicated in patients with known
allergy to corn or corn products.
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| dailymed-instance:supply |
Potassium Chloride
in 5% Dextrose and Sodium Chloride Injection, USP in VIAFLEX Plus
plastic container is available as follows: Exposure of
pharmaceutical products to heat should be minimized. Avoid excessive
heat. It is recommended the product be stored at room temperature
(25��C); brief exposure up to 40��C does not adversely affect the
product.
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| 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 Potassium Chloride in 5% Dextrose and
Sodium Chloride Injection, USP to patients receiving corticosteroids or
corticotropin. Potassium Chloride
in 5% Dextrose and Sodium Chloride Injection, USP should be used with
caution in patients with overt or subclinical diabetes
mellitus.<br/>Pregnancy::<br/>Teratogenic
Effects:<br/>Pediatric Use:: Safety and
effectiveness of Potassium Chloride in 5% Dextrose and Sodium
Chloride Injection, USP in pediatric patients have not been
established by adequate and well-controlled studies. However,
the use of potassium chloride injection in pediatric patients to
treat potassium deficiency states when oral replacement therapy
is not feasible is referenced in the medical literature. Dextrose is
safe and effective for the stated indications in pediatric
patients (see Indications and Usage). As reported in the literature, the dosage selection
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. Frequent monitoring of serum
glucose concentrations is required when dextrose is prescribed
to pediatric patients, particularly neonates and low birth
weight infants.<br/>Geriatric Use: Clinical
studies of Potassium Chloride in 5% Dextrose and Sodium Chloride
Injection, USP did not include sufficient numbers of subjects
aged 65 and over to determine whether they respond differently
from younger subjects. Other reported clinical experience has
not identified differences in responses between the 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.<br/>Carcinogenesis and
Mutagenesis and Impairment of Fertility: Studies
with Potassium Chloride in 5% Dextrose and Sodium Chloride
Injection, USP have not been performed to evaluate carcinogenic
potential, mutagenic potential or effects on
fertility.<br/>Nursing Mothers: It is not
known whether this drug is excreted in human milk. Because many
drugs are excreted in human milk, caution should be exercised
when Potassium Chloride in 5% Dextrose and Sodium Chloride Injection, USP is administered to a nursing mother. For
patients receiving potassium supplement at greater than
maintenance rates, frequent monitoring of serum potassium levels
and serial EKGs are recommended. Do not
administer unless solution is clear and seal is
intact.
|
| dailymed-instance:genericMe... |
Potassium chloride, dextrose and sodium chloride
|
| dailymed-instance:fullName |
Potassium chloride, dextrose and sodium chloride (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.
|
| dailymed-instance:warning |
Potassium Chloride
in 5% Dextrose and Sodium Chloride Injection, USP 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. Potassium Chloride
in 5% Dextrose and Sodium Chloride Injection, USP 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. Injections
containing carbohydrates with low electrolyte concentration should not
be administered simultaneously with blood through the same
administration set because of the possibility of pseudoagglutination or
hemolysis. The container label for these injections bears the statement:
Do not administer simultaneously with blood. The intravenous
administration of Potassium Chloride in 5% Dextrose and Sodium Chloride
Injection, USP 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 the injection. The
risk of solute overload causing congested states with peripheral and
pulmonary edema is directly proportional to the electrolyte
concentrations of the injection. In patients with
diminished renal function, administration of Potassium Chloride in 5%
Dextrose and Sodium Chloride Injection, USP may result in sodium or
potassium retention. In very low birth
weight infants, excessive or rapid administration of dextrose injection
may result in increased serum osmolality and possible intracerebral
hemorrhage. Potassium salts
should never be administered by IV push.
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| dailymed-instance:indicatio... |
Potassium Chloride
in 5% Dextrose and Sodium Chloride Injection, USP is indicated as a
source of water, electrolytes and calories.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Potassium chloride, dextrose and sodium chloride
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