sodium bicarbonate injection, solution HOSPIRA, INC.
Sodium Bicarbonate Injection, USP
THE CORRECTION OF
Ansyr® II Syringe
Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic,
hypertonic solution of sodium bicarbonate (NaHCO3) in water for
injection for administration by the intravenous route as an electrolyte replenisher
and systemic alkalizer.
Solutions are offered in concentrations
of 7.5% and 8.4%. See table in HOW SUPPLIEDsection for contents and characteristics.
in the Ansyr® II syringe have an approximate pH of 8.0 (7.5
The solutions contain no bacteriostat, antimicrobial
agent or added buffer and are intended only for use as a single-dose injection.
When smaller doses are required, the unused portion should be discarded with
the entire unit.
Sodium bicarbonate, 84 mg is equal
to one milliequivalent each of Na+ and HCO3¯. Sodium
Bicarbonate, USP is chemically designated NaHCO3, a white crystalline
powder soluble in water.
Water for Injection, USP is
chemically designated H2O.
The syringe is
molded from a specially formulated polypropylene. Water permeates from inside
the container at an extremely slow rate which will have an insignificant effect
on solution concentration over the expected shelf life. Solutions in contact
with the plastic container may leach out certain chemical components from
the plastic in very small amounts; however, biological testing is supportive
of the safety of the syringe material.
Ansyr® II— Unit of Use Syringe
Intravenous sodium bicarbonate therapy increases plasma bicarbonate,
buffers excess hydrogen ion concentration, raises blood pH and reverses the
clinical manifestations of acidosis.
in water dissociates to provide sodium (Na+) and bicarbonate (HCO3¯ )
ions. Sodium (Na+) is the principal cation of the extracellular
fluid and plays a large part in the therapy of fluid and electrolyte disturbances.
Bicarbonate (HCO3¯ ) is a normal constituent of body
fluids and the normal plasma level ranges from 24 to 31 mEq/liter. Plasma
concentration is regulated by the kidney through acidification of the urine
when there is a deficit or by alkalinization of the urine when there is an
excess. Bicarbonate anion is considered “labile” since at a
proper concentration of hydrogen ion (H+) it may be converted to
carbonic acid (H2CO3) and thence to its volatile form,
carbon dioxide (CO2) excreted by the lung. Normally a ratio of
1:20 (carbonic acid; bicarbonate) is present in the extracellular fluid. In
a healthy adult with normal kidney function, practically all the glomerular
filtered bicarbonate ion is reabsorbed; less than 1% is excreted in the urine.
INDICATIONS AND USAGE
Sodium Bicarbonate Injection, USP is indicated in the treatment
of metabolic acidosis which may occur in severe renal disease, uncontrolled
diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal
circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium
bicarbonate is further indicated in the treatment of certain drug intoxications,
including barbiturates (where dissociation of the barbiturate-protein complex
is desired), in poisoning by salicylates or methyl alcohol and in hemolytic
reactions requiring alkalinization of the urine to diminish nephrotoxicity
of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated
in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
of metabolic acidosis should, if possible, be superimposed on measures designed
to control the basic cause of the acidosis − e.g., insulin in uncomplicated
diabetes, blood volume restoration in shock. But since an appreciable time
interval may elapse before all of the ancillary effects are brought about,
bicarbonate therapy is indicated to minimize risks inherent to the acidosis
Vigorous bicarbonate therapy is required in
any form of metabolic acidosis where a rapid increase in plasma total CO2 content
is crucial − e.g., cardiac arrest, circulatory insufficiency due to
shock or severe dehydration, and in severe primary lactic acidosis or severe
Sodium Bicarbonate Injection, USP is contraindicated in patients
who are losing chloride by vomiting or from continuous gastrointestinal suction,
and in patients receiving diuretics known to produce a hypochloremic alkalosis.
Solutions containing sodium ions 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.
patients with diminished renal function, administration of solutions containing
sodium ions may result in sodium retention.
administration of these solutions can cause fluid and/or solute overloading
resulting in dilution of serum electrolyte concentrations, overhydration,
congested states or pulmonary edema.
should be avoided, see ADVERSE REACTIONS.
Do not use unless solution is clear and the container or
seal is intact. Discard unused portion.
large loads of sodium given with bicarbonate require that caution be exercised
in the use of sodium bicarbonate in patients with congestive heart failure
or other edematous or sodium-retaining states, as well as in patients with
oliguria or anuria. See table in HOW SUPPLIEDsection for amounts of sodium present in solutions.
must be exercised in the administration of parenteral fluids, especially those
containing sodium ions, to patients receiving corticosteroids or corticotropin.
depletion may predispose to metabolic alkalosis and coexistent hypocalcemia
may be associated with carpopedal spasm as the plasma pH rises. These dangers
can be minimized if such electrolyte imbalances are appropriately treated
prior to or concomitantly with bicarbonate infusion.
The aim of all bicarbonate therapy is to produce a substantial
correction of the low total CO2 content and blood pH, but the risks
of overdosage and alkalosis should be avoided. Hence, repeated fractional
doses and periodic monitoring by appropriate laboratory tests are recommended
to minimize the possibility of overdosage.
Additives may be incompatible; norepinephrine and dobutamine
are incompatible with sodium bicarbonate solution.
addition of sodium bicarbonate to parenteral solutions containing calcium
should be avoided, except where compatibility has been previously established.
Precipitation or haze may result from sodium bicarbonate/calcium admixtures. NOTE: Do not use the injection if it contains precipitate.
may be incompatible. Consult with pharmacist, if available. When introducing
additives, use aseptic technique, mix thoroughly and do not store.
Teratogenic Effects. Pregnancy Category C. Animal reproduction studies
have not been conducted with sodium bicarbonate. It is also not known whether
sodium bicarbonate can cause fetal harm when administered to a pregnant woman
or can affect reproduction capacity. Sodium bicarbonate should be given to
a pregnant woman only if clearly needed.
Rapid injection (10 mL/min) of hypertonic Sodium Bicarbonate
Injection, USP solutions into neonates and children under two years of age
may produce hypernatremia, a decrease in cerebrospinal fluid pressure and
possible intracranial hemorrhage. The rate of administration in such patients
should therefore be limited to no more than 8 mEq/kg/day. A 4.2% solution
may be preferred for such slow administration. In emergencies such as cardiac
arrest, the risk of rapid infusion must be weighed against the potential for
fatality due to acidosis.
Clinical studies of Sodium Bicarbonate 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
frequency of decreased hepatic, renal, or cardiac function and of concomitant
disease or other drug therapy.
Overly aggressive therapy with Sodium Bicarbonate Injection,
USP can result in metabolic alkalosis (associated with muscular twitchings,
irritability, and tetany) and hypernatremia.
extravasation of intravenously administered hypertonic solutions of sodium
bicarbonate have been reported to cause chemical cellulitis because of their
alkalinity, with tissue necrosis, ulceration or sloughing at the site of infiltration.
Prompt elevation of the part, warmth and local injection of lidocaine or hyaluronidase
are recommended to reduce the likelihood of tissue sloughing from extravasated
Should alkalosis result, the bicarbonate should be stopped
and the patient managed according to the degree of alkalosis present. 0.9%
sodium chloride injection intravenous may be given; potassium chloride also
may be indicated if there is hypokalemia. Severe alkalosis may be accompanied
by hyperirritability or tetany and these symptoms may be controlled by calcium
gluconate. An acidifying agent such as ammonium chloride may also be indicated
in severe alkalosis. See WARNINGS and PRECAUTIONS.
DOSAGE AND ADMINISTRATION
Sodium Bicarbonate Injection, USP is administered by the
arrest, a rapid intravenous dose of one to two 50 mL syringes (44.6
to 100 mEq) may be given initially and continued at a rate of 50 mL (44.6
to 50 mEq) every 5 to 10 minutes if necessary (as indicated by arterial pH
and blood gas monitoring) to reverse the acidosis. Caution should be observed
in emergencies where very rapid infusion of large quantities of bicarbonate
is indicated. Bicarbonate solutions are hypertonic and may produce an undesirable
rise in plasma sodium concentration in the process of correcting the metabolic
acidosis. In cardiac arrest, however, the risks from acidosis exceed those
urgent forms of metabolic acidosis, Sodium Bicarbonate Injection,
USP may be added to other intravenous fluids. The amount of bicarbonate to
be given to older children and adults over a four-to-eight-hour period is
approximately 2 to 5 mEq/kg of body weight − depending upon the severity
of the acidosis as judged by the lowering of total CO2 content,
blood pH and clinical condition of the patient. In metabolic acidosis associated
with shock, therapy should be monitored by measuring blood gases, plasma osmolarity,
arterial blood lactate, hemodynamics and cardiac rhythm. Bicarbonate therapy
should always be planned in a stepwise fashion since the degree of response
from a given dose is not precisely predictable. Initially an infusion of 2
to 5 mEq/kg body weight over a period of 4 to 8 hours will produce a measurable
improvement in the abnormal acid-base status of the blood. The next step of
therapy is dependent upon the clinical response of the patient. If severe
symptoms have abated, then the frequency of administration and the size of
the dose may be reduced.
In general, it is unwise to
attempt full correction of a low total CO2 content during the first
24 hours of therapy, since this may be accompanied by an unrecognized alkalosis
because of a delay in the readjustment of ventilation to normal. Owing to
this lag, the achievement of total CO2 content of about 20 mEq/liter
at the end of the first day of therapy will usually be associated with a normal
blood pH. Further modification of the acidosis to completely normal values
usually occurs in the presence of normal kidney function when and if the cause
of the acidosis can be controlled. Values for total CO2 which are
brought to normal or above normal within the first day of therapy are very
likely to be associated with grossly alkaline values for blood pH, with ensuing
undesired side effects.
Parenteral drug products should
be inspected visually for particulate matter and discoloration prior to administration,
whenever solution and container permit. See PRECAUTIONS.
Sodium Bicarbonate Injection, USP is supplied
in the following dosage forms.
Plastic Ansyr® II
Plastic Ansyr® II
Store at 20 to 25°C (68 to 77°F). [See USP Controlled