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SODIUM BICARBONATE
Overview
What is Sodium Bicarbonate?
Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHCO
) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer.
Solutions are offered in concentrations of 4.2%, 5.0%, 7.5% and 8.4%. See table in HOW SUPPLIED section for contents and characteristics.
Solution in LVP container has 0.9 mg/mL of edetate disodium, anhydrous added as a stabilizer.
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 HCO
¯. Sodium Bicarbonate, USP is chemically designated NaHCO
, a white crystalline powder soluble in water.
Water for Injection, USP is chemically designated H
O.
What does Sodium Bicarbonate look like?
What are the available doses of Sodium Bicarbonate?
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What should I talk to my health care provider before I take Sodium Bicarbonate?
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How should I use Sodium Bicarbonate?
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 blood pigments. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate.
Treatment 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 itself.
Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO
content is crucial ― e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis.
Sodium Bicarbonate Injection, USP is administered by the intravenous route.
In cardiac arrest,
In infants
In less urgent forms of metabolic acidosis,
In general, it is unwise to attempt full correction of a low total CO
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 CO
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 CO
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.
Do not use unless solution is clear and the container or seal is intact. Discard unused portion.
What interacts with Sodium Bicarbonate?
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.
What are the warnings of Sodium Bicarbonate?
Extravascular infiltration should be avoided, see ADVERSE REACTIONS.
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.
In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
Extravascular infiltration should be avoided, see ADVERSE REACTIONS.
What are the precautions of Sodium Bicarbonate?
The potentially 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 SUPPLIED section for amounts of sodium present in solutions.
Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.
Potassium 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.
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.
Drug Interactions
Additives may be incompatible; norepinephrine and dobutamine are incompatible with sodium bicarbonate solution.
The 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.
Do not use the injection if it contains precipitate.
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
Laboratory Tests
The aim of all bicarbonate therapy is to produce a substantial correction of the low total CO
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.
Pregnancy Category C.
What are the side effects of Sodium Bicarbonate?
Overly aggressive therapy with Sodium Bicarbonate Injection, USP can result in metabolic alkalosis (associated with muscular twitchings, irritability and tetany) and hypernatremia.
Inadvertent 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 prevent sloughing of extravasated I.V. infusions.
What should I look out for while using Sodium Bicarbonate?
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.
In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
Extravascular infiltration should be avoided, see ADVERSE REACTIONS.
What might happen if I take too much Sodium Bicarbonate?
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.
How should I store and handle Sodium Bicarbonate?
Storage and HandlingStore LEUKINE vials refrigerated at 2°C–8°C (36°F–46°F) in the original carton to protect from light. Do not freeze or shake. Do not use beyond the expiration date printed on the vial.Storage and HandlingStore LEUKINE vials refrigerated at 2°C–8°C (36°F–46°F) in the original carton to protect from light. Do not freeze or shake. Do not use beyond the expiration date printed on the vial.Sodium Bicarbonate Injection, USP is supplied in the following dosage forms:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2005 ©Hospira 2005 EN-1064 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USAABBOJECT is a trademark of the Abbott group of companies. Sodium Bicarbonate Injection, USP is supplied in the following dosage forms:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2005 ©Hospira 2005 EN-1064 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USAABBOJECT is a trademark of the Abbott group of companies. Sodium Bicarbonate Injection, USP is supplied in the following dosage forms:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2005 ©Hospira 2005 EN-1064 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USAABBOJECT is a trademark of the Abbott group of companies. Sodium Bicarbonate Injection, USP is supplied in the following dosage forms:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2005 ©Hospira 2005 EN-1064 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USAABBOJECT is a trademark of the Abbott group of companies. Sodium Bicarbonate Injection, USP is supplied in the following dosage forms:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2005 ©Hospira 2005 EN-1064 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USAABBOJECT is a trademark of the Abbott group of companies. Sodium Bicarbonate Injection, USP is supplied in the following dosage forms:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2005 ©Hospira 2005 EN-1064 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USAABBOJECT is a trademark of the Abbott group of companies. Sodium Bicarbonate Injection, USP is supplied in the following dosage forms:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2005 ©Hospira 2005 EN-1064 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USAABBOJECT is a trademark of the Abbott group of companies. Sodium Bicarbonate Injection, USP is supplied in the following dosage forms:Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]Revised: October, 2005 ©Hospira 2005 EN-1064 Printed in USAHOSPIRA, INC., LAKE FOREST, IL 60045 USAABBOJECT is a trademark of the Abbott group of companies.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Intravenous sodium bicarbonate therapy increases plasma bicarbonate, buffers excess hydrogen ion concentration, raises blood pH and reverses the clinical manifestations of acidosis.
Sodium bicarbonate in water dissociates to provide sodium (Na
) and bicarbonate (HCO
¯) 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 (HCO
¯) 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 (H
CO
) and thence to its volatile form, carbon dioxide (CO
) 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.
Non-Clinical Toxicology
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.
In patients with diminished renal function, administration of solutions containing sodium ions may result in sodium retention.
The intravenous administration of these solutions can cause fluid and/or solute overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema.
Extravascular infiltration should be avoided, see ADVERSE REACTIONS.
Caution should be exercised when propranolol is administered with drugs that have an effect on CYP2D6, 1A2, or 2C19 metabolic pathways. Co-administration of such drugs with propranolol may lead to clinically relevant drug interactions and changes in its efficacy and/or toxicity (see ).
The potentially 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 SUPPLIED section for amounts of sodium present in solutions.
Caution must be exercised in the administration of parenteral fluids, especially those containing sodium ions, to patients receiving corticosteroids or corticotropin.
Potassium 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.
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.
Drug Interactions
Additives may be incompatible; norepinephrine and dobutamine are incompatible with sodium bicarbonate solution.
The 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. Do not use the injection if it contains precipitate.
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
Laboratory Tests
The aim of all bicarbonate therapy is to produce a substantial correction of the low total CO 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.
Pregnancy Category C.
Overly aggressive therapy with Sodium Bicarbonate Injection, USP can result in metabolic alkalosis (associated with muscular twitchings, irritability and tetany) and hypernatremia.
Inadvertent 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 prevent sloughing of extravasated I.V. infusions.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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