FDA
Sodium Bicarbonate
The FDA lists this product in 24 strengths and forms.
Indications
Sodium bicarbonate injection 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.
Contraindications
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 .
Warnings and precautions
General Do not use unless solution is clear and the container or seal is intact. Discard unused portion. 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 amount of sodium present in the solution.
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.
Laboratory Tests The aim of all bicarbonate therapy is to produce a substantial correction of the low total CO 2 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. 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. NOTE: Do not use the injection if it contains precipitate. Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, consult with pharmacist, if available.
At a glance
- Brand name
- Sodium Bicarbonate
- Route
- Intravenous
- Dosage form
- Solution
- Applicant
- Anthea Pharma
- Status
- Prescription
- FDA approval
- 26 Jun 2025
- Application
- ANDA219701-001



