Overview
Potassium bicarbonate is a white, crystalline, slightly alkaline and salty substance. It is produced by the passage of carbon dioxide through an aqueous potassium carbonate solution. It is used in medicine as an antacid. It is registered in the FDA under the section of suitable, safe and effective ingredients for OTC antacids. This FDA denomination classifies potassium bicarbonate as a GRAS ingredient.
Indication
Potassium bicarbonate is used as an antacid, electrolyte replenisher and potassium supplement. It can also be used as an excipient in drug formulations. An antacid is a medication used to neutralize gastric acid in a short timeframe after ingestion and the effect is soon overcome by meal-stimulated acid secretion.
Associated Conditions
- Arrhythmias Cardiac caused by Hypokalemia
- Gastro-esophageal Reflux Disease (GERD)
- Hypocitraturia
- Hypokalemia
- Ketoacidosis caused by Hypokalemia
- Kidney Stones
- Neuromuscular Disorders caused by Hypokalemia
- Uric Acid Stones
- Calcium oxalate calculi Renal Calculi
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2020/12/03 | Early Phase 1 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Nomax Inc. | 51801-011 | ORAL | 782 mg in 1 1 | 12/19/2019 | |
| Qualitest Pharmaceuticals | 0603-4170 | ORAL | 25 meq in 1 1 | 4/20/2012 | |
| Nomax Inc. | 51801-007 | ORAL | 977.5 mg in 1 1 | 12/23/2019 | |
| Nomax Inc. | 51801-006 | ORAL | 977.5 mg in 1 1 | 12/23/2019 | |
| Tower Laboratories Ltd | 50201-2400 | ORAL | 25 meq in 1 1 | 10/8/2010 | |
| Nomax Inc. | 51801-014 | ORAL | 391 mg in 1 1 | 12/19/2019 | |
| Nomax Inc. | 51801-012 | ORAL | 782 mg in 1 1 | 12/19/2019 | |
| Nomax Inc. | 51801-001 | ORAL | 977.5 mg in 1 1 | 12/23/2019 | |
| Upsher-Smith Laboratories, Inc. | 0245-5326 | ORAL | 978 mg in 1 1 | 6/30/2020 | |
| Nomax Inc. | 51801-005 | ORAL | 977.5 mg in 1 1 | 12/23/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/30/2021 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| GASCOVID ADVANCE LIQUID | SIN16042P | SUSPENSION | 200 MG/10ML | 11/17/2020 | |
| GAVISCON ADVANCE-PEPPERMINT FLAVOUR SUSPENSION | SIN12635P | SUSPENSION | 200 mg/10 ml | 12/24/2004 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| CHLORVESCENT potassium 14 mmol effervescent tablet tube (reformulation) | 71981 | Medicine | A | 12/1/1999 | |
| GAVISCON EXTRA STRENGTH aniseed oral liquid bottle | 77810 | Medicine | A | 3/13/2001 | |
| GAVISCON EXTRA STRENGTH peppermint oral liquid bottle | 346341 | Medicine | A | 10/21/2020 |
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