Overview
Sodium bicarbonate is a white, crystalline powder that is commonly used as a pH buffering agent, an electrolyte replenisher, systemic alkalizer and in topical cleansing solutions.
Indication
Sodium bicarbonate is used for 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. Also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturateprotein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of blood pigments.
Associated Conditions
- Barbiturate intoxication
- Breast Cancer
- Constipation
- Dental Decay
- Duodenal Ulcer
- Dyspepsia
- Gastro-esophageal Reflux Disease (GERD)
- Gingival Bleeding
- Heartburn
- Helicobacter Infections
- Hyperkalemia
- Ischaemia
- Metabolic Acidosis
- Myocardial Infarction
- Plaque, Dental
- Pruritis of the skin
- Skin Irritation
- Upper GI Bleeding
- Upset stomach
- Zollinger-Ellison Syndrome
- Abdominal bloating
- Benign, active Gastric Ulcer
- Methyl alcohol poisoning
- Prophylaxis of Contrast-induced nephropathy
- Salicylate poisoning
- Severe Diarrhea
- Swelling of the gums
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/05/31 | Phase 2 | Recruiting | |||
2024/10/02 | Not Applicable | Recruiting | Hospital General de Mexicali | ||
2024/03/28 | Phase 1 | Recruiting | |||
2024/01/02 | Phase 1 | Completed | |||
2023/09/21 | Phase 4 | Terminated | |||
2023/09/21 | Not Applicable | Completed | |||
2023/07/03 | Phase 2 | Recruiting | |||
2023/04/18 | Phase 4 | Completed | Yuzuncu Yıl University | ||
2023/02/09 | Phase 3 | Recruiting | Oslo University Hospital | ||
2023/01/26 | Phase 3 | Recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Henry Schein, Inc. | 0404-9950 | INTRAVENOUS | 84 mg in 1 mL | 11/14/2023 | |
| ScieGen Pharmaceuticals, Inc. | 50228-363 | ORAL | 1100 mg in 1 1 | 11/6/2023 | |
| Hospira, Inc. | 0409-4900 | INTRAVENOUS | 84 mg in 1 mL | 1/19/2024 | |
| Oceanside Pharmaceuticals | 68682-990 | ORAL | 1680 mg in 1 1 | 10/11/2023 | |
| Lupin Pharmaceuticals,Inc. | 43386-090 | ORAL | 6.74 g in 274.31 g | 12/20/2016 | |
| Baxter Healthcare Corporation | 24571-111 | INTRAVENOUS | 2.21 g in 1 L | 11/1/2018 | |
| Zydus Lifesciences Limited | 70771-1102 | ORAL | 1100 mg in 1 1 | 9/27/2023 | |
| Henry Schein, Inc. | 0404-9951 | INTRAVENOUS | 42 mg in 1 mL | 11/14/2023 | |
| Exela Pharma Sciences, LLC | 51754-5012 | INTRAVENOUS | 42 mg in 1 mL | 9/27/2017 | |
| Novel Laboratories, Inc. | 40032-090 | ORAL | 6.74 g in 274.31 g | 2/8/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| BICART POWDER FOR HAEMODIALYSIS | SIN06382P | POWDER, FOR SOLUTION | 100% | 7/3/1991 | |
| ALKA-SELTZER TABLET (Lemon Flavour) | SIN08632P | TABLET | 1737 mg | 4/4/1996 | |
| KAOMIX ORAL MIXTURE | SIN08787P | SUSPENSION | 5% w/v | 7/3/1996 | |
| AROMAG ANTACID MIXTURE | SIN08784P | SUSPENSION | 5% w/v | 7/3/1996 | |
| SODIUM BICARBONATE CAPSULE 500 mg | SIN05414P | CAPSULE | 500 mg | 2/18/1991 | |
| BIBAG (5008 DESIGN) POWDER FOR HAEMODIALYSIS | SIN13822P | POWDER, FOR SOLUTION | 100 % | 7/2/2010 | |
| Ural Effervescent Granules | SIN14374P | GRANULE, EFFERVESCENT | 1.76g | 6/26/2013 | |
| BIBAG POWDER FOR HAEMODIALYSIS | SIN10583P | POWDER, FOR SOLUTION | 100% | 12/22/1998 | |
| GASCOVID LIQUID | SIN16041P | SUSPENSION | 267 mg/10ml | 11/17/2020 | |
| OHTA'S ISAN ANTACID POWDER | SIN05820P | POWDER | 600 mg/1.3 g | 5/3/1991 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Hemofiltration Replacement Fluid of Sodium Bicarbonate | 国药准字HJ20220049 | 化学药品 | 注射剂 | 5/18/2022 | |
| Sodium Bicarbonate Injection | 国药准字H20247327 | 化学药品 | 注射剂 | 12/24/2024 | |
| Sodium Bicarbonate Injection | N/A | 国药准字H20258009 | 化学药品 | 注射剂 | 1/9/2025 |
| Sodium Bicarbonate Injection | 国药准字H20258017 | 化学药品 | 注射剂 | 2/19/2025 | |
| Sodium Bicarbonate Injection | 国药准字H20258004 | 化学药品 | 注射剂 | 1/9/2025 | |
| Sodium Bicarbonate Injection | 国药准字H20258005 | 化学药品 | 注射剂 | 1/9/2025 | |
| Sodium Bicarbonate Injection | 国药准字H20247111 | 化学药品 | 注射剂 | 5/23/2024 | |
| Sodium Bicarbonate Injection | 国药准字H20258006 | 化学药品 | 注射剂 | 1/9/2025 | |
| Sodium Bicarbonate Injection | 国药准字H20258018 | 化学药品 | 注射剂 | 2/19/2025 | |
| Sodium Bicarbonate Injection | 国药准字H36021490 | 化学药品 | 注射剂 | 7/17/2022 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| PRISMASOL B0 SOLUTION FOR HAEMOFILTRATION AND HAEMODIALYSIS | N/A | N/A | N/A | 10/15/2013 | |
| BAROS EFFERVESCENT GRANULES | N/A | N/A | N/A | 9/6/1988 | |
| ISOCOLAN POWDER FOR ORAL SOLUTION | N/A | N/A | N/A | 8/19/2024 | |
| OHTA'S ISAN POWDER | N/A | N/A | N/A | 4/13/1987 | |
| ROTER TAB | N/A | N/A | N/A | 10/23/2001 | |
| TAITIAN STOMACH TAB | N/A | N/A | N/A | 5/17/1999 | |
| MELOCE BABY WATER | N/A | N/A | N/A | 2/17/1981 | |
| PHYSIONEAL 40 DEXTROSE 1.5% P.D. SOLUTION | N/A | N/A | N/A | 10/10/2005 | |
| MARCHING ANTI-GRIPE WATER | N/A | N/A | N/A | 5/31/2007 | |
| PHYSIONEAL 40 DEXTROSE 2.5% P.D. SOLUTION | N/A | N/A | N/A | 10/10/2005 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| MOVICOL JUNIOR CHOCOLATE FLAVOUR powder for oral solution sachet | 207698 | Medicine | A | 4/3/2013 | |
| GAVISCON EXTRA STRENGTH peppermint flavour chewable tablet blister pack | 156040 | Medicine | A | 10/21/2008 | |
| GAVISCON DUAL ACTION mixed berry flavour oral liquid bottle | 328032 | Medicine | A | 12/23/2019 | |
| HEMOSOL B0 haemofiltration / haemodiafiltration solution bag | 260992 | Medicine | A | 12/14/2016 | |
| MACROVIC FLAVOURED JUNIOR powder for oral solution sachet | 220580 | Medicine | A | 2/27/2014 | |
| MACROVIC JUNIOR powder for oral solution sachet | 220582 | Medicine | A | 2/27/2014 | |
| Hydralyte Tropical Flavoured Effervescent Electrolyte Tablets | 370691 | Medicine | A | 7/7/2021 | |
| MULTIBIC potassium-free, Solution for Haemofiltration | 357591 | Medicine | A | 8/2/2021 | |
| APOHEALTH Cystitis Relief oral powder sachet | 227717 | Medicine | A | 9/8/2014 | |
| Physioneal 40 Glucose 3.86%w/v Peritoneal Dialysis solution Single Bag | 215417 | Medicine | A | 9/27/2013 |
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