Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1641
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| rdf:type | |
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Lactated Ringers and Dextrose (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. All injections in VIAFLEX plastic containers are intended for intravenous administration
using sterile equipment. 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 weight infants, because of the increased
risk of hyperglycemia/hypoglycemia. 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 judgement 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... |
Lactated Ringer's
and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution for
fluid and electrolyte replenishment and caloric supply in a single dose
container for intravenous administration. Each 100 mL contains 5 g
Dextrose Hydrous, USP*; 600 mg Sodium Chloride, USP (NaCl); 310 mg
Sodium Lactate (C3H5NaO3); 30 mg of Potassium Chloride, USP (KCl); and
20 mg Calcium Chloride, USP (CaCl2��2H20). It contains no antimicrobial
agents. Approximate pH 5.0
(4.0 to 6.5). Lactated Ringer's
and 5% Dextrose Injection, USP administered intravenously has value as a
source of water, electrolytes, and calories. One liter has an ionic
concentration of 130 mEq sodium, 4 mEq potassium, 2.7 mEq calcium, 109
mEq chloride and 28 mEq lactate. The osmolarity is 525 mOsmol/L (calc).
Normal physiologic range is approximately 280 to 310 mOsmol/L.
Administration of substantially hypertonic solutions may cause vein
damage. The caloric content is 180 kcal/L. The VIAFLEX plastic
container is fabricated from a specially formulated polyvinyl chloride
(PL 146 Plastic). 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 to5 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... |
Lactated Ringer's
and 5% Dextrose 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. Lactated Ringer's
and 5% Dextrose Injection, USP produces a metabolic alkalinizing effect.
Lactate ions are metabolized ultimately to carbon dioxide and water,
which requires the consumption of hydrogen cations.
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Solutions
containing dextrose may be contraindicated in patients with known
allergy to corn or corn products.
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| dailymed-instance:supply |
Lactated Ringer's
and 5% Dextrose Injection, USP in VIAFLEX plastic containers 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.<br/>Directions for use
of VIAFLEX plastic container: WARNING: Do not use plastic
containers in series connections. Such use could result in air
embolism due to residual air being drawn from the primary
container before administration of the fluid from the secondary
container is completed.<br/>To Open: Tear
overwrap down side at slit and remove solution container. Some
opacity of the plastic due to moisture absorption during the
sterilization process may be observed. This is normal and does
not affect the solution quality or safety. The opacity will
diminish gradually. Check for minute leaks by squeezing inner
bag firmly. If leaks are found, discard solution as sterility
may be impaired. If supplemental medication is desired, follow
directions below.<br/>Preparation for Administration: 1. Suspend
container from eyelet support. 2. Remove
plastic protector from outlet port at bottom of container. 3. Attach
administration set. Refer to complete directions accompanying
set<br/>To Add Medication: Warning: Additives may be
incompatible.<br/>To add medication
before solution administration: 1. Prepare
medication site. 2. Using
syringe with 19 to 22 gauge needle, puncture medication port and
inject. 3. Mixsolution and medication thoroughly. For high density medication
such as potassium chloride, squeeze ports while ports are
upright and mix thoroughly.<br/>To add medication
during solution administration: 1. Close
clamp on the set. 2. Prepare
medication site. 3. Using
syringe with 19 to 22 gauge needle, puncture resealable
medication port and inject. 4. Remove
container from IV pole and/or turn to an upright position. 5. Evacuate
both ports by squeezing them while container is in the upright
position. 6. Mix
solution and medication thoroughly. 7. Return
container to in use position and continue administration. Baxter Healthcare Corporation Deerfield,
IL 60015 USA Printed in
USA Baxter,
VIAFLEX, and PL 146 are trademarks of Baxter International
Inc.
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| 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. Lactated Ringer's
and 5% Dextrose Injection, USP should be used with caution. Excess
administration may result in metabolic alkalosis. Caution must be
exercised in the administration of Lactated Ringer's and 5% Dextrose
Injection, USP to patients receiving corticosteroids or corticotropin. Lactated Ringer's
and 5% Dextrose 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 Lactated Ringer's and 5% Dextrose Injection,
USP in pediatric patients have not been established by adequate
and well controlled trials, however, the use of lactated
ringer's and dextrose solutions in the pediatric population is
referenced in the medical literature. The warnings, precautions
and adverse reactions identified in the label copy should be
observed in the pediatric population. In very low
birth weight infants, excessive or rapid administration of
dextrose injection may result in increased serum osmolality and
possible hemorrhage.<br/>Carcinogenesis,
mutagenesis, impairment of fertility: Studies
with Lactated Ringer's and 5% Dextrose 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 Lactated Ringer's and 5% Dextrose Injection, USP is
administered to a nursing mother.<br/>Geriatric Use: Clinical
studies of Lactated Ringer's and 5% Dextrose 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 frequencyof decreased
hepatic, renal, or cardiac function, and of concomitant disease
or drug therapy. Do not
administer unless solution is clear and the seal is
intact.
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| dailymed-instance:genericMe... |
Sodium chloride, sodium lactate, potassium chloride, calcium chloride and dextrose
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| dailymed-instance:fullName |
Lactated Ringers and Dextrose (Injection, Solution)
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| dailymed-instance:adverseRe... |
Allergic reactions
or anaphylactoid symptoms such as localized or generalized urticaria and
pruritus; periorbital, facial, and/or laryngeal edema, coughing,
sneezing, and/or difficulty with breathing have been reported during
administration of Lactated Ringer's and 5% Dextrose Injection, USP. The
reporting frequency of these signs and symptoms is higher in women during pregnancy. 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 |
Lactated Ringer's
and 5% Dextrose 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. Lactated Ringer's
and 5% Dextrose 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. Lactated Ringer's and 5% Dextrose Injection, USP should be used with great care 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 these ions,
such as severe hepatic insufficiency. Lactated Ringer's
and 5% Dextrose Injection, USP should not be administered simultaneously with blood through the same administration set because of the likelihood
of coagulation. The intravenous
administration of Lactated Ringer's and 5% Dextrose 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 Lactated Ringer's and 5%
Dextrose Injection, USP may result in sodium or potassium retention. Lactated Ringer's
and 5% Dextrose Injection, USP is not for use in the treatment of lactic
acidosis.
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| dailymed-instance:indicatio... |
Lactated Ringer's
and 5% Dextrose Injection, USP is indicated as a source of water,
electrolytes and calories or as an alkalinizing agent.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
Lactated Ringers and Dextrose
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