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
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/01/09 | Not Applicable | Recruiting | |||
2022/10/03 | Phase 4 | Recruiting | Lars Wiuff Andersen | ||
2022/04/21 | Not Applicable | UNKNOWN | |||
2021/11/09 | Not Applicable | Recruiting | |||
2021/08/16 | Phase 4 | Recruiting | |||
2021/07/30 | Phase 2 | Recruiting | |||
2021/07/07 | N/A | Completed | |||
2021/03/19 | Not Applicable | Active, not recruiting | |||
2021/02/26 | Not Applicable | Completed | Zonguldak Ataturk State Hospital | ||
2020/12/03 | Early Phase 1 | Not yet recruiting |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Exela Pharma Sciences, LLC | 51754-5011 | INTRAVENOUS | 84 mg in 1 mL | 9/27/2017 | |
| Baxter Healthcare Corporation | 24571-102 | INTRAVENOUS | 3.09 g in 1 L | 11/1/2018 | |
| Medical Purchasing Solutions, LLC | 71872-7310 | INTRAVENOUS | 84 mg in 1 mL | 11/10/2023 | |
| Proficient Rx LP | 71205-984 | ORAL | 1100 mg in 1 1 | 2/1/2023 | |
| Woodward Pharma Services LLC | 69784-700 | ORAL | 1100 mg in 1 1 | 6/8/2021 | |
| Cipla USA Inc. | 69097-914 | ORAL | 1100 mg in 1 1 | 11/1/2023 | |
| ScieGen Pharmaceuticals, Inc. | 50228-364 | ORAL | 1100 mg in 1 1 | 11/6/2023 | |
| 78271 | 78271-041 | TOPICAL | 5 g in 25 g | 5/27/2025 | |
| Oceanside Pharmaceuticals | 68682-104 | ORAL | 1100 mg in 1 1 | 10/11/2023 | |
| Ajanta Pharma USA Inc. | 27241-032 | ORAL | 1100 mg in 1 1 | 11/23/2023 |
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 |
|---|---|---|---|---|---|
| SODIUM BICARBONATE INTRAVENOUS INFUSION BP 4.2% w/v | SIN09851P | INJECTION | 4.2% w/v | 6/26/1998 | |
| SODIUM BICARBONATE INJECTION BP 8.4% | SIN05953P | INJECTION | 8.4 g/100 ml | 5/23/1991 | |
| SODIUM BICARBONATE INTRAVENOUS INFUSION 8.4% w/v | SIN09226P | INJECTION | 8.4% w/v | 2/20/1997 | |
| GAVISCON DOUBLE ACTION LIQUID, SUSPENSION | SIN14016P | SUSPENSION | 213MG/10ML | 9/19/2011 | |
| DUOSOL WITHOUT POTASSIUM SOLUTION FOR HAEMOFILTRATION | SIN15783P | SOLUTION, STERILE | 3.59g/1000ml | 8/20/2019 | |
| GAVISCON LIQUID SACHETS | SIN13738P | SUSPENSION | 267MG/10ML | 11/23/2009 | |
| E-Z-GAS II GRANULES | SIN06442P | GRANULE | 2.22 g/4 g | 7/11/1991 | |
| DUOSOL WITH 4 MMOL/L POTASSIUM SOLUTION FOR HAEMOFILTRATION | SIN15785P | SOLUTION, STERILE | 3.59g/1000ml | 8/20/2019 | |
| INON GRANULES | SIN03440P | GRANULE | 525 mg/1.8 g | 6/8/1989 | |
| GAVISCON PEPPERMINT TABLETS | SIN13947P | TABLET, CHEWABLE | 133.5MG | 4/14/2011 |
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H36021242 | 化学药品 | 注射剂 | 7/17/2022 | |
| Sodium Bicarbonate Injection | 国药准字H42020501 | 化学药品 | 注射剂 | 10/12/2022 | |
| Sodium Bicarbonate Injection | 国药准字H20258008 | 化学药品 | 注射剂 | 1/9/2025 | |
| Sodium Bicarbonate Injection | 国药准字H20253723 | 化学药品 | 注射剂 | 3/25/2025 | |
| Sodium Bicarbonate Injection | 国药准字H42022235 | 化学药品 | 注射剂 | 6/10/2022 | |
| Sodium Bicarbonate Injection | 国药准字H20253516 | 化学药品 | 注射剂 | 3/4/2025 | |
| Sodium Bicarbonate Injection | 国药准字H20258022 | 化学药品 | 注射剂 | 2/27/2025 | |
| Sodium Bicarbonate Injection | 国药准字H20258026 | 化学药品 | 注射剂 | 3/10/2025 | |
| Sodium Bicarbonate Injection | 国药准字H20247291 | 化学药品 | 注射剂 | 11/21/2024 | |
| Sodium Bicarbonate Injection | 国药准字H20253531 | 化学药品 | 注射剂 | 3/4/2025 |
PPB Drug Approvals
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Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| LEMON FLAVOURED ENO FRUIT SALT | N/A | N/A | N/A | 8/8/1983 | |
| BABY LOVE ANTI-GRIPE WATER | N/A | N/A | N/A | 12/22/2008 | |
| PHOXILIUM 1.2MMOL/L PHOSPHATE SOLUTION FOR HAEMODIALYSIS/HAEMOFILTRATION | N/A | N/A | N/A | 3/26/2012 |
TGA Drug Approvals
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Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| Hydrate + Energy Raspberry Burst | 468609 | Medicine | A | 11/14/2024 | |
| Hydralyte Lemon Lime Effervescent Electrolyte Tablets | 217300 | Medicine | A | 11/14/2013 | |
| PHOXILIUM 1.2 mmol/L phosphate haemofiltration / haemodiafiltration solution bag | 261012 | Medicine | A | 12/14/2016 | |
| Chemists' Own Cystitis Relief effervescent granules sachet | 297741 | Medicine | A | 12/19/2017 | |
| Coles Electrolyte | 442602 | Medicine | A | 2/27/2024 | |
| Essential Health Electrolyte Lemon & Lime Flavour Effervescent Tablets | 279845 | Medicine | A | 9/2/2016 | |
| MOVICOL FLAVOUR FREE powder for oral solution sachet | 181834 | Medicine | A | 4/4/2011 | |
| Guardian Hydration + Electrolytes Watermelon | 450630 | Medicine | A | 6/3/2024 | |
| PHYSIONEAL 40 Glucose 3.86% w/v Peritoneal Dialysis Solution Twin Bag | 119079 | Medicine | A | 5/31/2005 | |
| LAX-SACHETS HALF powder for oral solution sachet | 202203 | Medicine | A | 10/24/2012 |
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