FDA Approves Sodium Bicarbonate Injection for Metabolic Acidosis and Urinary AlkalizationFDA Approves New Ready-to-Use Sodium Bicarbonate Injection for Acidosis and Poisoning

FDA Published October 13, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Note: Do not dilute sodium bicarbonate injection; avoid use when rapid administration is required.

The FDA has approved sodium bicarbonate injection (NDA218524) for two indications: to raise plasma pH in adult and pediatric patients with clinically significant metabolic acidosis, and to alkalinize the urine in drug poisoning in cases where urinary drug elimination is enhanced by urinary alkalinization. The approval provides a ready-to-administer formulation that requires no further dilution prior to intravenous infusion.

The label specifies weight-based dosing over a four- to eight-hour period, with lower doses in pediatric patients under 2 years of age, including neonates. It carries a limitation of use: the product should not be used where rapid administration of sodium bicarbonate is required, such as cardiac arrest, because a more concentrated solution is needed in those settings.

Clinicians should note that treatment of metabolic acidosis with sodium bicarbonate should be superimposed on measures designed to address the underlying cause. The label does not report clinical trial data.

＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)

Mechanism of Action

Sodium bicarbonate injection is an alkalinizing agent. It raises plasma pH in patients with clinically significant metabolic acidosis and alkalinizes the urine in drug poisoning when urinary drug elimination is enhanced by urinary alkalinization. The label does not provide further mechanistic detail.

Indication & Patient Population

Sodium bicarbonate injection is indicated to raise plasma pH in adult and pediatric patients with clinically significant metabolic acidosis. It is also indicated to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinization. Limitation of use: do not use sodium bicarbonate injection in settings where rapid administration of sodium bicarbonate is required, such as cardiac arrest; in such situations use a more concentrated solution.

Dosing & Administration

Sodium bicarbonate injection is administered by intravenous infusion via a dedicated line. Do NOT dilute prior to administration. Inspect parenteral drug products for particulate matter and discoloration prior to administration; do not use if the solution is colored or cloudy or if it contains particulate matter. Discard any unused portion. Individualize dosage depending on the severity of the acidosis. Treatment of metabolic acidosis with sodium bicarbonate should be superimposed on measures designed to address the underlying cause of metabolic acidosis.

Recommended dosage in adults and pediatric patients 2 years of age and older: administer 2 mEq/kg to 5 mEq/kg over a four- to eight-hour period, depending upon the severity of metabolic acidosis as assessed by serum bicarbonate concentration, total CO2, blood pH, and the clinical condition of the patient.

Recommended dosage in pediatric patients less than 2 years of age, including neonates: administer 1 mEq/kg to 2 mEq/kg over a four- to eight-hour period. Avoid rapid or bolus administration.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

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. The label also states that rapid or bolus administration should be avoided in pediatric patients less than 2 years of age, including neonates.

Place in Therapy

Sodium bicarbonate injection is an intravenous alkalinizing agent for clinically significant metabolic acidosis and for urinary alkalinization in select drug poisonings. It is not intended for settings requiring rapid administration, such as cardiac arrest, where a more concentrated solution should be used. Dosing is weight-based and individualized to the severity of acidosis, and it should be used alongside measures that address the underlying cause of metabolic acidosis.

The FDA has approved a new sodium bicarbonate injection. This medicine raises the pH of blood in adults and children who have a serious condition called metabolic acidosis, where the blood becomes too acidic. It also makes urine more alkaline to help the body get rid of certain drugs in cases of poisoning. The approval covers both adults and children, including newborns, with lower doses for children under 2 years old.

The main advantage of this new product is that it is ready to give right away. It does not need to be mixed or diluted before use, which can save time and reduce mistakes. Dosing is based on the patient's weight and is given slowly over 4 to 8 hours.

There is an important limit. This product should not be used when a very fast effect is needed, such as during cardiac arrest. In those cases, a stronger, more concentrated solution is required. Also, treating acidosis with sodium bicarbonate should go along with treating the underlying cause.

This approval gives doctors another tool, but it is not a cure on its own. If you have questions about this treatment, talk to your doctor or pharmacist.

What this means for you:

A new ready-to-use sodium bicarbonate injection is approved for serious acid buildup and certain poisonings, but not for emergencies like cardiac arrest.

Study Details

Study typeFda approval

PublishedAug 2026

View Original Abstract ↓

1 INDICATIONS AND USAGE Sodium bicarbonate injection is an alkalinizing agent indicated: • to raise plasma pH in adult and pediatric patients with clinically significant metabolic acidosis. ( 1.1 ) • to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion. ( 1.2 ) Limitation of Use Do not use sodium bicarbonate injection in settings where rapid administration of sodium bicarbonate is required, such as cardiac arrest. In such situations use a more concentrated solution. 1.1 Treatment of Clinically Significant Metabolic Acidosis Sodium bicarbonate injection is indicated to raise plasma pH in adult and pediatric patients with clinically significant metabolic acidosis. 1.2 Urinary Alkalization in Drug Poisoning Sodium bicarbonate injection is indicated to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion. Limitation of Use Do not use sodium bicarbonate injection in settings where rapid administration of sodium bicarbonate is required, such as cardiac arrest. In such situations use a more concentrated solution.

FDA Approves Sodium Bicarbonate Injection for Metabolic Acidosis and Urinary AlkalizationFDA Approves New Ready-to-Use Sodium Bicarbonate Injection for Acidosis and Poisoning

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