Sodium Bicarbonate
(Sodium Bicarbonate Injection,)Sodium Bicarbonate Prescribing Information
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. 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 C02 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.
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.
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 reduce the likelihood of tissue sloughing from extravasated I.V. solutions.
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.
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.
Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic, hypertonic solution of sodium bicarbonate (NaHC03) in water for injection for administration by the intravenous route as an electrolyte replenisher and systemic alkalizer.
Solution is offered in concentration of 8.4%. See table in
HOW SUPPLIEDSodium Bicarbonate Injection, USP is supplied in the following strength and package size:
| NDC Code: | Conc % | mg/ml (NaHCO3) | mEq/mL (Na+) | mEq/mL (HCO3-) | mEq/ Container size (mL) | mOsmol |
| 81298-7620-1 (Single Dose vial) | 8.4 | 84 | 1 | 1 | 50/50 | 2/mL |
The 50 mL Sodium Bicarbonate Injection vials are supplied as 20 vials per carton with a single package insert (NDC Code: 81298-7620-3).
Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C to 77°F). [See USP Controlled Room Temperature.]
Revised: 07/2024
Manufactured for:
Long Grove Pharmaceuticals, LLC.
Rosemont, IL 60018 USA
Manufactured in India
US/LF/089 V01
The solution contains no bacteriostat, antimicrobial agent or added buffer and is intended only for use as a single-dose injection, the approximate pH of the solution is 8. When smaller doses are required, the unused portion should be discarded.
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.