Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/16
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Potassium Chloride in 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 anddiscoloration prior to administration whenever solution and container
permit. Do not administer unless solution is clear and seal is intact.
Use of a final filter is recommended during administration of all
parenteral solutions, where possible. All injections in
AVIVA 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 concentrationand caloric content are shown in
Table 1. The flexible
container is made with non-latex plastic materials specially designed
for a wide range of parenteral drugs including those requiring delivery
in containers made of polyolefins or polypropylene. For
example, the AVIVA container system is compatible with and appropriate
for use in the admixture and administration of paclitaxel. In
addition, the AVIVA container system is compatible with and appropriate
for use in the admixture and administration of all drugs deemed
compatible with existing polyvinyl chloride container systems.
The solution contact materials do not contain PVC, DEHP, or other
plasticizers. The suitability of
the container materials has been established through biological
evaluations, which have shown the container passes Class VI U.S.
Pharmacopeia (USP) testing for plastic containers. These tests confirm
the biological safety of the container system. The flexible
container is a closed system, and air is prefilled in the container to
facilitate drainage. The container does not require entry of
external air during administration. The container has
two ports: one is the administration outlet port for attachment
of an intravenous administration set and the other port has a medication
site for addition of supplemental medication (See Directions for
Use). The primary function of the overwrap is to protect the
container from the physical environment.
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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: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 AVIVA 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:precautio... |
General: Do not
connect flexible plastic containers of intravenous solutions in
series connections. Such use could result in air embolism due to
residual air being drawn from one container before
administration of the fluid from a secondary container is
completed. Pressurizing intravenous solutions contained in flexible
plastic containers to increase flow rates can result in air
embolism if the residual air in the container is not fully
evacuated prior to administration. Use of a
vented intravenous administration set with the vent in the open
position could result in air embolism. Vented intravenous
administration sets with the vent in the open position should
not be used with flexible plastic containers. For
patients receiving potassium supplement at greater than
maintenance rates, frequent monitoring of serum potassium levels and serial EKGs are recommended. Potassium
Chloride in 5% Dextrose and Sodium Chloride Injection, USP
should be used with caution in patients with overt or subclinical diabetes mellitus.<br/>Laboratory Tests: 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.<br/>Drug Interactions: Caution
must be exercised in the administration of Potassium Chloride in
5% Dextrose and Sodium Chloride Injection, USP to patients
receiving corticosteroids or corticotropin. Studies have not been conducted to evaluate additional drug/drug or
drug/food interactions with Potassium Chloride in 5% Dextrose
and Sodium Chloride Injection, USP.<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/>Pregnancy:<br/>Teratogenic
Effects:<br/>Labor and Delivery: Studies
have not been conducted to evaluate the effects of Potassium
Chloride in 5% Dextrose and Sodium Chloride Injection, USP on
labor and delivery. Caution should be exercised when
administering this drug during labor and delivery.<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.<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 the responses 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 drug therapy. This drug
is known to be substantially excreted by the kidney, and the
risk of toxic reactions to this drug 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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| dailymed-instance:genericMe... |
Dextrose monohydrate, Sodium Chloride and Potassium Chloride
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| dailymed-instance:fullName |
Potassium Chloride in 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.
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| 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:name |
Potassium Chloride in Dextrose and Sodium Chloride
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