Approved Drug Label (PDF)
4
Contraindications
CONTRAINDICATIONS
(Additions
and/or revisions are underlined)
Ringer’s Injection is contraindicated in:
Patients
with known hypersensitivity to the
product or any ingredients in the formulation (see WARNINGS).
Newborns
(less than or equal to 28 days of age) receiving concomitant treatment with ceftriaxone, even
if separate infusion lines are
used due to the risk of
fatal ceftriaxone-calcium salt
precipitation in the neonate’s bloodstream.
5
Warnings and Precautions
WARNINGS
(Additions and/or revisions are underlined)
Hypersensitivity
Hypersensitivity reactions, including anaphylaxis, have been reported with Ringer’s Injection. Stop the
infusion immediately if
signs or symptoms of a hypersensitivity reaction
develop. Appropriate therapeutic countermeasures must be instituted as clinically indicated.
Electrolyte Imbalances
Hyperkalemia
Potassium-containing solutions, including Ringer’s Injection,
may
increase the
risk of hyperkalemia.
Patient’s at increased risk of developing hyperkalemia
include those:
With conditions predisposing to hyperkalemia and/or associated with increased sensitivity to potassium, such
as patients
with severe renal impairment,
acute dehydration, extensive tissue injury
or burns, certain cardiac disorders such as congestive heart failure
Treated concurrently or recently with
agents or products that cause or
increase the risk
of hyperkalemia.
Avoid use of
Ringer’s Injection in patients with, or at risk
for, hyperkalemia. If use cannot
be avoided, monitor serum potassium
concentrations.
Hypernatremia and Hyperchloremia
Electrolyte imbalances such as
hypernatremia, hyperchloremia, and metabolic acidosis may occur with Ringer’s
Injection.
Conditions
that may increase the risk
of hypernatremia, fluid overload and edema (peripheral
and/or pulmonary), include patients with aldosteronism; hypertension, congestive heart failure, liver
disease, and pre-eclampsia.
Certain medications, such as corticosteroids or corticotropin,
may also increase risk of sodium and
fluid retention.
Avoid Ringer’s
Injection in patients
with, or at risk for, hypernatremia
or hyperchloremia. Administration
of Ringer’s Injection may result in acute kidney injury (AKI)
in patients with or at risk
for hyperchloremia. If use cannot
be avoided,
monitor serum sodium and
chloride concentrations acid-base balance, and renal function.
Hyponatremia
Ringer’s Injection may lead
to hyponatremia in at-risk patients.
Hyponatremia can lead to
acute hyponatremic encephalopathy characterized
by
headache, nausea, seizures, lethargy, and vomiting.
Patients with brain edema are at
particular risk of severe,
irreversible and
life-threatening brain injury.
The risk of
hospital-acquired hyponatremia is
increased in patients with cardiac or pulmonary failure, and
in patients with non-osmotic vasopressin
release (including SIADH)
treated with high volume of
hypotonic Ringer’s Injection.
The risk for hyponatremia is increased in pediatric
patients, elderly patients, postoperative patients,
those with psychogenic polydipsia, and
in patients treated with medications
that increase the risk of
hyponatremia (such as
diuretics, certain antiepileptic and psychotropic medications).
Patients at increased risk
for developing complications
of hyponatremia such as hyponatremic encephalopathy, include pediatric patients, women (in
particular, premenopausal women), patients
with hypoxemia, and patients with
underlying central nervous
system disease. Avoid
Ringer’s Injection in patients
with or at risk for hyponatremia. If use cannot
be avoided, monitor serum sodium concentrations.
Rapid correction of hyponatremia is potentially
dangerous with risk of
serious neurologic complications.
Brain adaptations reducing
risk of cerebral
edema make the brain vulnerable
to injury when chronic hyponatremia is too rapidly corrected, which is known as osmotic demyelination syndrome (ODS).
To
avoid complications, monitor serum sodium and chloride concentrations, fluid status,
acid-base balance, and signs
of
neurologic complications.
Fluid Overload
Depending on the volume and rate
of infusion, the patient’s
underlying clinical condition, the
intravenous administration of Ringer’s
Injection can cause
electrolyte disturbances such as
overhydration and congested states including pulmonary congestion and edema.
Avoid Ringer’s
Injection in patients
with or at risk for fluid and/or solute overloading.
If use cannot be avoided, monitor fluid balance, electrolyte concentrations
and
acid base balance,
as needed and especially
during prolonged use.
Hypercalcemia
Ringer’s Injection may cause
hypercalcemia. Avoid intravenous administration of Ringer’s
Injection in patients with: hypercalcemia or
conditions predisposing to hypercalcemia; and in patients with calcium renal calculi
or a history of such calculi.
PRECAUTIONS
(Additions and/or revisions are underlined)
Patients with Severe Renal Impairment
Administration of Ringer’s
Injection in patients with or at risk of severe renal impairment, may result
in hyperkalemia, hypernatremia, hyperchloremia and/or fluid
overload. Avoid
Ringer’s Injection in patients with
severe renal impairment. If use cannot be avoided, monitor patients
with severe renal impairment
for
development of these adverse reactions.
Pregnancy
Animal reproduction studies have not been conducted
with Ringer’s Injection. It is also not
known whether Ringer’s Injection can cause fetal harm
when administered to a
pregnant woman or can affect reproduction capacity. Ringer’s Injection should be given to a pregnant woman only if the
potential benefit justifies
the potential risk to the fetus.
Pediatric Use
The use of
Ringer’s Injection in pediatric patients is based
on clinical practice.
Pediatric patients
are at increased
risk of developing
hyponatremia as well as
for developing encephalopathy as a
complication of hyponatremia.
Geriatric Use
Geriatric patients are at increased
risk of developing electrolyte imbalances. Ringer's Injection
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. Therefore, 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. Consider monitoring renal function
in elderly patients.
6
Adverse Reactions
ADVERSE REACTIONS
(Additions and/or
revisions are underlined)
The
following adverse
reactions associated with the
use of Ringer’s Injection were identified in clinical trials or postmarketing reports. Because these reactions were reported
voluntarily from a population of uncertain size, it is not always
possible to estimate their frequency, reliably,
or
to establish a causal
relationship to drug exposure.
Hypersensitivity
reactions: anaphylaxis, shortness of breath, palpitations, erythema, hives,
urticaria, chills, and pyrexia
Metabolism
and nutritional
disorders: electrolyte imbalance, fluid overload, and hyponatremia
Nervous System Disorders: hyponatremic encephalopathy.
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.
7
Drug Interactions
DRUG INTERACTIONS
(Additions and/or revisions are underlined)
Ceftriaxone
For information on interaction with ceftriaxone, See CONTRAINDICATIONS.
Other Products that Cause Hyperkalemia
Administration of Ringer’s
Injection in patients treated
concurrently or recently
with products that are associated
with hyperkalemia increases the risk of
severe and potentially fatal hyperkalemia,
in particular in the presence
of other risk factors for hyperkalemia.
Avoid use of
Ringer’s Injection in patients receiving such
products (e.g, potassium sparing diuretics,
ACE inhibitors, angiotensin II receptor antagonists,
or the immunosuppressants cyclosporine and tacrolimus). If use cannot be avoided, monitor serum potassium
concentrations
Digoxin
Administration of calcium may increase
the effects of digitalis and lead to serious
or fatal cardiac arrhythmia. In
patients treated with digoxin,
consider reducing the volume, and/or rate of administration.
Other Products that Affect
Fluid and/or Electrolyte Balance
Administration of Ringer’s
Injection in patients treated
concomitantly with medications associated
with sodium and fluid retention
may
increase the risk of
hypernatremia and volume overload.
Avoid use of Ringer’s
Injection in patients receiving such products, such
as corticosteroids
or corticotropin. If use cannot
be avoided, monitor serum
electrolytes, fluid balance, and acid-base balance.
Other Drugs that Increase the Risk of Hyponatremia
Administration of Ringer’s
Injection in patients treated
concomitantly with medications associated
with hyponatremia may increase
the risk of developing hyponatremia.
Avoid use of
Ringer’s Injection in patients receiving products, such as diuretics, and certain antiepileptic and psychotropic
medications. Drugs that increase the vasopressin effect
reduce renal electrolyte free water excretion and may also
increase the risk of hyponatremia following treatment
with intravenous fluids. If use cannot be
avoided, monitor
serum sodium concentrations.
Other Drugs that Increase the Risk of Hypercalcemia
Avoid Ringer’s
Injection in patients
treated with thiazide diuretics
or vitamin D, as these can increase
the risk of hypercalcemia.
Other
DIRECTIONS FOR USE OF VIAFLEX PLASTIC CONTAINER
(Additions and/or
revisions are underlined)
For
information on risk
of air embolism – see PRECAUTIONS.
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