FDA Approves Sodium Bicarbonate Injection for Metabolic Acidosis and Urinary AlkalinizationFDA approves sodium bicarbonate injection for acidosis and poisonings.

FDA Published July 14, 2026 DOI ↗ Editorial oversight: Dr. Amelia Tan, PhD · Internal Medicine & Chronic Disease

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Key Takeaway

Consider sodium bicarbonate injection for raising pH in metabolic acidosis or alkalinizing urine in drug poisoning, but avoid in cardiac arrest.

The FDA has approved sodium bicarbonate injection for raising plasma pH in adults and pediatric patients with clinically significant metabolic acidosis and for urinary alkalinization in drug poisoning cases where enhanced elimination is desired. The approval provides a ready-to-administer formulation for intravenous infusion, with dosing based on age and severity of acidosis. For patients 2 years and older, the recommended dose is 2 to 5 mEq/kg over 4-8 hours; for those under 2 years, including neonates, 1 to 2 mEq/kg over the same period. The drug should not be used in settings requiring rapid administration, such as cardiac arrest, where more concentrated solutions are needed. This approval offers a standardized option for clinicians managing metabolic acidosis and certain poisonings.

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

Mechanism of Action

Sodium bicarbonate is an alkalinizing agent that raises plasma pH by increasing bicarbonate levels and buffering excess acid.

Indication & Patient Population

Sodium bicarbonate injection is indicated to raise plasma pH in adults and pediatric patients with clinically significant metabolic acidosis. It is also indicated to alkalinize the urine in drug poisoning in adults and pediatric patients when urinary drug elimination is enhanced by urinary alkalinization. Limitation of Use: Do not use in settings where rapid administration is required, such as cardiac arrest.

Dosing & Administration

Administer by intravenous infusion. Do NOT dilute prior to administration. For adults and pediatric patients 2 years and older: 2 mEq/kg to 5 mEq/kg over 4-8 hours, depending on severity. For pediatric patients less than 2 years (including neonates): 1 mEq/kg to 2 mEq/kg over 4-8 hours. Avoid rapid or bolus administration. Individualize dosage based on serum bicarbonate, total CO2, blood pH, and clinical condition.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Contraindicated in patients losing chloride by vomiting or continuous gastrointestinal suction, and in patients receiving diuretics known to produce hypochloremic alkalosis.

Place in Therapy

Sodium bicarbonate injection is a treatment option for clinically significant metabolic acidosis and for urinary alkalinization in drug poisoning, used alongside measures addressing the underlying cause.

The FDA has approved a new formulation of sodium bicarbonate injection for treating metabolic acidosis and for urinary alkalinization in certain poisonings. Metabolic acidosis is a condition where the body has too much acid, which can be serious. The drug helps raise the pH of the blood to a safer level. It is also used in some drug overdoses to help the body get rid of the drug faster.

This approval is for a ready-to-administer intravenous infusion. It is meant for adults and children of all ages, including newborns. The dose depends on the patient's age and how severe the acidosis is. For patients 2 years and older, the dose is 2 to 5 mEq per kilogram of body weight given over 4 to 8 hours. For younger children, the dose is lower.

This new formulation is not meant for emergencies like cardiac arrest, where a more concentrated solution is needed. It provides a standardized option for hospitals and clinics. This can make treatment more consistent and easier for healthcare providers.

If you or a loved one has metabolic acidosis or has been poisoned, talk to your doctor about the best treatment options. This approval does not mean everyone with acidosis should get this drug. Your doctor will decide if it is right for you based on your specific health needs.

What this means for you:

A new ready-to-use sodium bicarbonate injection is now available for acidosis and poisonings. Talk to your doctor.

Study Details

Study typeFda approval

PublishedJul 2026

View Original Abstract ↓

1 INDICATIONS AND USAGE Sodium bicarbonate injection is an alkalinizing agent indicated: to raise plasma pH in adults 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 adults 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 AlkalinizationFDA approves sodium bicarbonate injection for acidosis and poisonings.

Study Details

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FDA Approves Sodium Bicarbonate Injection for Metabolic Acidosis and Urinary AlkalinizationFDA approves sodium bicarbonate injection for acidosis and poisonings.

Study Details

Systematic review confirms clip anastomosis improves one and two year primary patency rates for arteriovenous fistula creation compared to suture methods

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Clinical research that matters. Delivered to your inbox.

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