This solution should be used with care in patients with
hypervolemia, renal insufficiency, urinary tract obstruction, or impending or
frank cardiac decompensation.
Extraordinary electrolytes losses such as may occur
during protracted nasogastric suction, vomiting, diarrhea or gastrointestinal
fistula drainage may necessitate additional electrolyte supplementation.
Additional essential electrolytes, minerals and vitamins
should be supplied as needed.
Sodium-containing solutions should be administered with
caution to patients receiving corticosteroids or corticotropin, or to other
Care should be exercised in administering solutions
containing sodium or potassium to patients with renal or cardiovascular
insufficiency, with or without congestive heart failure, particularly if they
are postoperative or elderly.
The osmolarity of 5% Dextrose in Lactated Ringer's
Injection is 530 mOsmol/liter (calc). Administration of substantially
hypertonic solutions may cause venous irritation, including phlebitis.
Solutions containing calcium should be used with caution
in the presence of cardiac disease, particularly when accompanied by renal
disease. Parenteral calcium should be administered with extreme caution to
patients receiving digitalis preparations.
Solutions containing lactate should be used with caution.
Excess administration may result in metabolic alkalosis.
The conversion of lactate to bicarbonate is markedly
delayed in the presence of tissue anoxia and reduced capacity of the liver to
metabolize lactate. This may occur under conditions such as metabolic acidosis
associated with circulatory insufficiency, extracorporeal circulation,
hypothermia, glycogen storage disease, liver dysfunction, respiratory
alkalosis, shock or cardiac decompensation.
Solutions containing dextrose should be used with caution
in patients with overt or known subclinical diabetes mellitus, or carbohydrate
intolerance for any reason.
To minimize the risk of possible incompatibilities
arising from mixing this solution with other additives that may be prescribed,
the final infusate should be inspected for cloudiness or precipitation immediately
after mixing, prior to administration, and periodically during administration.
Do not connect flexible plastic containers in series in
order to avoid air embolism due to possible residual air contained in the
If administration is controlled by a pumping device, care
must be taken to discontinue pumping action before the container runs dry or air
embolism may result. If administration is not controlled by a pumping device,
refrain from applying excessive pressure (greater than 300mmHg) causing
distortion to the container such as wringing or twisting. Such handling could
result in breakage of the container.
This solution is intended for intravenous administration
using sterile equipment. It is recommended that intravenous administration
apparatus be replaced at least once every 24 hours.
Use only if solution is clear and container and seals are
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. Significant deviations
from normal concentrations may require tailoring of the electrolyte pattern, in
this or an alternative solution.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Studies with 5% Dextrose in Lactated Ringer's Injection
have not been performed to evaluate carcinogenic potential, mutagenic potential
or effects on fertility.
Pregnancy Category C
Animal reproduction studies have not been conducted with
5% Dextrose in Lactated Ringer's Injection. It is also not known whether 5%
Dextrose in Lactated Ringer's Injection can cause fetal harm when administered
to a pregnant woman or can affect reproduction capacity. 5% Dextrose in
Lactated Ringer's Injection should be given to a pregnant woman only if clearly
Labor And Delivery
The effects of 5% Dextrose in Lactated Ringer's Injection
on the duration of labor or delivery, on the possibility that forceps delivery
or other intervention or resuscitation of the newborn will be necessary, and on
the later growth, development, and functional maturation of the child are
As reported in the literature, 5% Dextrose in Lactated
Ringer's Injection has been administered during labor and delivery. Caution
should be exercised, and the fluid balance, glucose and electrolyte concentrations,
and acid-base balance, of both mother and fetus should be evaluated
periodically or whenever warranted by the condition of the patient or fetus.
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 in Lactated Ringer's Injection is administered to a nursing
Safety and effectiveness of 5% Dextrose in Lactated
Ringer's Injection in pediatric patients has not been established by adequate
and well-controlled studies. However, as referenced in the medical literature, potassium
chloride injection has been used to treat pediatric patients with potassium
deficiency when oral replacement therapy is not feasible.
For patients receiving potassium supplement at greater
than maintenance rates, frequent monitoring of serum potassium levels and
serial EKGs are recommended.
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.
In neonates or in very small infants even small volumes
of fluid may affect fluid and electrolyte balance. Care must be exercised in
treatment of neonates, especially pre-term neonates, whose renal function may be
immature and whose ability to excrete fluid and solute loads may be limited.
Fluid intake, urine output, and serum glucose and electrolytes should be
monitored closely. See WARNINGS and DOSAGE AND ADMINISTRATION.
Clinical studies of 5% Dextrose in Lactated Ringer's
Injection 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 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.
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.