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.
Background
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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2010/05/25 | Not Applicable | Terminated | |||
2010/02/26 | Phase 3 | Completed | |||
2009/11/01 | Phase 3 | Completed | |||
2009/07/31 | Phase 4 | UNKNOWN | CardioVascular Research Foundation, Korea | ||
2009/06/30 | Phase 3 | Terminated | MD Scientific | ||
2009/06/16 | Phase 2 | Completed | Community Medical Center, Scranton, PA | ||
2009/04/27 | Phase 2 | Completed | |||
2009/04/09 | Phase 2 | Terminated | |||
2008/12/16 | Phase 4 | Completed | Procter and Gamble | ||
2008/10/21 | Phase 4 | Terminated | University of Erlangen-Nürnberg Medical School |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Zydus Pharmaceuticals USA Inc. | 68382-501 | ORAL | 1100 mg in 1 1 | 3/24/2023 | |
| Braintree Laboratories, Inc. | 52268-700 | ORAL | 6.36 g in 1 L | 5/28/2021 | |
| Ajanta Pharma USA Inc. | 27241-031 | ORAL | 1100 mg in 1 1 | 11/23/2023 | |
| International Medication Systems, Limited | 76329-3352 | INTRAVENOUS | 84 mg in 1 mL | 9/25/2017 | |
| Hospira, Inc. | 0409-4916 | INTRAVENOUS | 75 mg in 1 mL | 11/23/2020 | |
| Oceanside Pharmaceuticals | 68682-102 | ORAL | 1100 mg in 1 1 | 10/11/2023 | |
| A-S Medication Solutions | 50090-6521 | ORAL | 6.74 g in 4 L | 9/28/2022 | |
| Civica | 72572-740 | INTRAVENOUS | 84 mg in 1 mL | 1/9/2024 | |
| Lukare Medical, LLC | 55792-007 | INTRATHECAL | 19 mg in 10 mL | 11/16/2018 | |
| Lupin Pharmaceuticals,Inc. | 43386-090 | ORAL | 6.74 g in 274.31 g | 2/17/2023 |
EMA Drug Approvals
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Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
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Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
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Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Sodium Bicarbonate Injection | 国药准字H32021914 | 化学药品 | 注射剂 | 8/13/2020 | |
| Sodium Bicarbonate Injection | 国药准字H20057131 | 化学药品 | 注射剂 | 6/4/2020 | |
| Sodium Bicarbonate Injection | 国药准字H20153284 | 化学药品 | 注射剂 | 11/28/2020 | |
| Sodium Bicarbonate Injection | 国药准字H32022138 | 化学药品 | 注射剂 | 8/31/2020 | |
| Sodium Bicarbonate Injection | 国药准字H20044245 | 化学药品 | 注射剂 | 5/26/2020 | |
| Sodium Bicarbonate Injection | 国药准字H13022134 | 化学药品 | 注射剂 | 5/22/2020 | |
| Sodium Bicarbonate Injection | 国药准字H62020214 | 化学药品 | 注射剂 | 4/8/2020 | |
| Sodium Bicarbonate Injection | 国药准字H51021424 | 化学药品 | 注射剂(注射液) | 10/13/2020 | |
| Sodium Bicarbonate Injection | 国药准字H20183434 | 化学药品 | 注射剂 | 5/26/2023 | |
| Sodium Bicarbonate Injection | 国药准字H42020420 | 化学药品 | 注射剂 | 3/29/2022 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Hydrodol After Powder | 340033 | Medicine | A | 7/23/2020 | |
| PHYSIONEAL 40 Glucose 3.86% w/v Peritoneal Dialysis Solution Bag | 97431 | Medicine | A | 5/31/2005 | |
| ENO REGULAR oral powder jar | 40655 | Medicine | A | 7/30/1992 | |
| Hydrate Apple + Berry | 472193 | Medicine | A | 12/9/2024 | |
| CHEMISTS' OWN CONSTIPATION RELIEF WITH ELECTROLYTES powder for oral solution sachet | 220587 | Medicine | A | 2/27/2014 | |
| GAVISCON COOL cool mint flavour oral liquid bottle | 127289 | Medicine | A | 4/26/2006 | |
| PHYSIONEAL 40 Glucose 2.27% w/v Peritoneal Dialysis Solution Twin Bag | 119078 | Medicine | A | 5/31/2005 | |
| CHEMISTS' OWN MACROGOL JUNIOR WITH ELECTROLYTES powder for oral solution sachet | 220586 | Medicine | A | 2/27/2014 | |
| Physioneal 40 Glucose 1.36% w/v Peritoneal Dialysis solution - Twin Bag | 215517 | Medicine | A | 9/30/2013 | |
| Physioneal 40 Glucose 2.27%w/v Peritoneal Dialysis solution - Twin Bag | 215416 | Medicine | A | 9/27/2013 |