Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3091
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Dextrose and Electrolyte No. 48 (Injection, Solution)
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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 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... |
5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose
Injection, Type 1, 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*, 260 mg Sodium Lactate
(CHNaO), 141 mg Potassium
Chloride, USP (KCl), 31 mg Magnesium Chloride, USP
(MgC���6H0), 20 mg Monobasic
Potassium Phosphate, NF (KHPO), and 12 mg Sodium
Chloride, USP (NaCl). It contains no antimicrobial agents. pH 5.0 (4.0
to 6.5). 5% Dextrose and
Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose
Injection, Type 1, USP) administered intravenously has value as a source
of water, electrolytes, and calories. One liter has an ionic
concentration of 25 mEq sodium, 20 mEq potassium, 3 mEq magnesium, 24
mEq chloride, 23 mEq lactate and 3 mEq phosphate as
HPO. The osmolarity is 348 mOsmol/L (calc).
Normal physiologic osmolarity range is approximately 280 to 310
mOsmol/L. Administration of substantially hypertonic solutions
(���600 mOsmol/L) 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 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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5% Dextrose and
Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose
Injection, Type 1, USP) has value as a source of water, electrolytes and
calories. They are capable of inducing diuresis depending on the
clinical condition of the patient. 5% Dextrose and
Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose
Injection, Type 1, USP) produce 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 |
5% Dextrose and
Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose
Injection, Type 1, USP) in VIAFLEX plastic containers is available as
shown below: 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... |
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. 5% Dextrose and
Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose
Injection, Type 1, USP) should be used with caution. Excess
administration may result in metabolic alkalosis. Caution must be
exercised in the administration of these injections to patients
receiving corticosteroids or corticotropin. 5% Dextrose and
Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose
Injection, Type 1, 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 5% Dextrose and Electrolyte No. 48 Injection
(Multiple Electrolytes and Dextrose Injection, Type 1, USP) in
pediatric patients have not been established by adequate and
well controlled trials, however, the use of dextrose and
electrolytes 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/>Geriatric Use: Clinical
studies of 5% Dextrose and Electrolyte No. 48 Injection
(Multiple Electrolytes and Dextrose Injection, Type 1, 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 foran 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. 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.<br/>Carcinogenesis and
Mutagenesis and Impairment of Fertility: Studies
with 5% Dextrose and Electrolyte No. 48 Injection (Multiple
Electrolytes and Dextrose Injection, Type 1, 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 5% Dextrose and Electrolyte No. 48 Injection (Multiple
Electrolytes and Dextrose Injection, Type 1, USP) is
administered to a nursing mother. Do not
administer simultaneously with blood. Do not administer unless
solution is clear and seal is intact.
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Sodium Lactate, Potassium Chloride, Magnesium
Chloride, Monobasic Potassium Phosphate, Sodium Chloride
and Dextrose monohydrate
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Dextrose and Electrolyte No. 48 (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 |
5% Dextrose and
Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose
Injection, Type 1, 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. 5% Dextrose and
Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose
Injection, Type 1, 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. 5% Dextrose and
Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose
Injection, Type 1, 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. 5% Dextrose and
Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose
Injection, Type 1, USP) should not be administered simultaneously with
blood through the same administration set because of the possibility of
pseudoagglutination or hemolysis. The intravenous
administration of 5% Dextrose and Electrolyte No. 48 Injection (Multiple
Electrolytes and Dextrose Injection, Type 1, 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 5% Dextrose and Electrolyte
No. 48 Injection (Multiple Electrolytes and Dextrose Injection, Type 1,
USP) may result in sodium or potassium retention. 5% Dextrose and Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose
Injection, Type 1, USP) is not for use in the treatment of lactic
acidosis.
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| dailymed-instance:indicatio... |
5% Dextrose and
Electrolyte No. 48 Injection (Multiple Electrolytes and Dextrose
Injection, Type 1, USP) is indicated as a source of water, electrolytes,
and calories or as an alkalinizing agent.
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Dextrose and Electrolyte No. 48
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