pharmacopeia
GET
/api/v1/drug/sodium-bicarbonate

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Acid-Base Activity; Electrolyte Activity.

Indications

Sourced from openFDA
  • 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.

Contraindications

Sourced from openFDA
  • 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.contraindicated

Dosage & administration

Sourced from openFDA

Sodium Bicarbonate Injection, USP is administered by the intravenous route. In cardiac arrest , a rapid intravenous dose of one to two 50 mL vials (44.6 to 100 mEq) may be given initially and continued at a rate of 50 mL (44.6 to 50 mEq) every 5 to 10 minutes if necessary (as indicated by arterial pH and blood gas monitoring) to reverse the acidosis. Caution should be observed in emergencies where very rapid infusion of large quantities of bicarbonate is indicated. Bicarbonate solutions are hypertonic and may produce an undesirable rise in plasma sodium concentration in the process of correcting the metabolic acidosis. In cardiac arrest, however, the risks from acidosis exceed those of hypernatremia. In less urgent forms of metabolic acidosis , Sodium Bicarbonate Injection, USP may be added to other intravenous fluids. The amount of bicarbonate to be given to older children and adults over a four-to-eight-hour period is approximately 2 to 5 mEq/kg of body weight - depending upon the severity of the acidosis as judged by the lowering of total CO 2 content, blood pH and clinical condition of the patient. In metabolic acidosis associated with shock, therapy should be monitored by measuring blood gases, plasma osmolarity, arterial blood lactate, hemodynamics and cardiac rhythm. Bicarbonate therapy should always be planned in a stepwise fashion since the degree of response from a given dose is not precisely predictable.

Warnings & precautions

Sourced from openFDA

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 .

Adverse reactions

Sourced from openFDA

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.

Overdosage

Sourced from openFDA

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 .

Approval history

Sourced from openFDA
  • Jul 13, 1984NDANDA019011Azurity
  • Apr 22, 1991NDANDA019797Azurity
  • Sep 27, 1996NDANDA020577Lukare Medical Llc
  • Jun 15, 2004NDANDA021636Salix
  • Feb 27, 2006NDANDA021849Salix
  • Oct 25, 2006NDANDA021703Vantive Us Hlthcare
  • Dec 1, 2009NDANDA022281Riley Consumer
  • Jan 13, 2015NDANDA207026Vantive Us Hlthcare

FDA shortages

View JSON

Reference statistics from the openFDA drug-shortage dataset. For a live view, consult the FDA database directly. Not clinical guidance.

  • Sodium Bicarbonate, Injection, 10 mEq/10 mL (8.4%, 1 mEq/mL) Syringes (NDC 0409-4900-14)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Sodium Bicarbonate, Injection, 2.5 mEq/5 mL (4.2%, 0.5 mEq/mL) (NDC 0409-5555-01)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated
  • Sodium Bicarbonate, Injection, 2.5 mEq/5 mL (4.2%, 0.5 mEq/mL) (NDC 0409-5555-02)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Sodium Bicarbonate, Injection, 42 mg/1 mL (NDC 0409-5534-14)To be discontinued
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Sodium Bicarbonate, Injection, 42 mg/1 mL (NDC 51754-5012-4)Active
    Sponsor: Exela Pharma Sciences, LLC
    Updated
  • Sodium Bicarbonate, Injection, 42 mg/1 mL (NDC 63323-083-05)Active
    Sponsor: Fresenius Kabi USA, LLC
    Updated
  • Sodium Bicarbonate, Injection, 44.6 mEq/50 mL (7.5%, 0.9 mEq/mL) Syringes (NDC 0409-4916-14)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Sodium Bicarbonate, Injection, 5 mEq/10 mL (4.2%, 0.5 mEq/mL) Syringes (NDC 0409-5534-14)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Sodium Bicarbonate, Injection, 50 mEq/50 mL (8.4%, 1 mEq/mL) (NDC 0409-6625-14)Active
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Sodium Bicarbonate, Injection, 50 mEq/50 mL (8.4%, 1 mEq/mL) (NDC 0409-6625-35)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Other
    Updated
  • Sodium Bicarbonate, Injection, 50 mEq/50 mL (8.4%, 1 mEq/mL) Syringes (NDC 0409-6637-14)Active
    Sponsor: Hospira, Inc., a Pfizer Company · Reason: Discontinuation of the manufacture of the drug
    Updated
  • Sodium Bicarbonate, Injection, 75 mg/1 mL (NDC 0409-4916-14)To be discontinued
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 0409-4900-14)To be discontinued
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 0409-6637-14)To be discontinued
    Sponsor: Hospira, Inc., a Pfizer Company
    Updated
  • Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 51754-5001-5)Active
    Sponsor: Exela Pharma Sciences, LLC
    Updated
  • Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 51754-5011-4)Active
    Sponsor: Exela Pharma Sciences, LLC
    Updated
  • Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 63323-089-50)Active
    Sponsor: Fresenius Kabi USA, LLC
    Updated
  • Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 76329-3352-1)Active
    Sponsor: Amphastar Pharmaceuticals, Inc. · Reason: Demand increase for the drug
    Updated
  • Sodium Bicarbonate, Injection, 84 mg/1 mL (NDC 81298-7620-3)Active
    Sponsor: Long Grove Pharmaceuticals LLC
    Updated

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
27,530 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Acute Kidney Injury2,2338.1%
  2. 2Renal Failure1,9116.9%
  3. 3Drug Ineffective1,8646.8%
  4. 4Chronic Kidney Disease1,8446.7%
  5. 5Off Label Use1,7346.3%
  6. 6Diarrhoea1,6345.9%
  7. 7Nausea1,5515.6%
  8. 8Vomiting1,2584.6%
  9. 9Pain1,1954.3%
  10. 10Dyspnoea1,1794.3%
  11. 11Death1,1694.2%
  12. 12Anaemia1,1474.2%
  13. 13Fatigue1,1384.1%
  14. 14Headache1,0643.9%
  15. 15Pneumonia1,0123.7%

Literature

View JSON

Recent PubMed references pinned to Sodium Bicarbonate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 574 ClinicalTrials.gov registrations naming Sodium Bicarbonate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Sodium Bicarbonate work?
Mechanism-of-action classes: Acid-Base Activity; Electrolyte Activity.
What is Sodium Bicarbonate used for?
According to FDA labeling, Sodium Bicarbonate carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Sodium Bicarbonate?
Sodium Bicarbonate is classified as Electrolyte solutions, Salt solutions, Acid-Base Activity, Electrolyte Activity, Gastric Acid Alteration, Increased Renal HCO3- Excretion.
What are the brand names for Sodium Bicarbonate?
Sodium Bicarbonate is marketed under brand names including Alka-Seltzer, Bromo Seltzer Antacid Pain Reliever, Ceo-Two, Desempacho, E-Z-Gas II, GaviLyte-C, GaviLyte-N, Gavilyte-G.
What are the contraindications for Sodium Bicarbonate?
Sodium Bicarbonate labeling lists contraindications including: 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.. Always consult the full prescribing information and a clinician.
Note. Data for sodium-bicarbonate is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients