Overview
A white crystal or crystalline powder used as an electrolyte replenisher, in the treatment of hypokalemia, in buffer solutions, and in fertilizers and explosives. The FDA withdrew its approval for the use of all solid oral dosage form drug products containing potassium chloride that supply 100 mg or more of potassium per dosage unit, except for controlled-release dosage forms and those products formulated for preparation of solution prior to ingestion.
Background
A white crystal or crystalline powder used as an electrolyte replenisher, in the treatment of hypokalemia, in buffer solutions, and in fertilizers and explosives. The FDA withdrew its approval for the use of all solid oral dosage form drug products containing potassium chloride that supply 100 mg or more of potassium per dosage unit, except for controlled-release dosage forms and those products formulated for preparation of solution prior to ingestion.
Indication
For use as an electrolyte replenisher and in the treatment of hypokalemia.
Associated Conditions
- Dehydration
- Dry Mouth
- Hypokalemia
- Hypotonic Dehydration
- Hypovolaemia
- Isotonic Dehydration
- Markedly Reduced Food Intake
- Metabolic Acidosis
- Hypodermoclysis
- Mild Metabolic acidosis
- Mild, moderate Metabolic Acidosis
- Ocular edema
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/02/12 | Not Applicable | Completed | Yuanyuan Zhang | ||
2014/10/03 | Phase 2 | Completed | |||
2013/04/18 | Phase 1 | Completed | Norgine | ||
2013/03/26 | Phase 4 | Completed | Diakonhjemmet Hospital | ||
2013/01/18 | Phase 2 | Completed | |||
2012/11/26 | Phase 3 | Completed | |||
2012/11/01 | Phase 4 | Completed | |||
2012/10/26 | Phase 2 | Completed | Norgine | ||
2012/09/21 | Phase 4 | Completed | Norgine | ||
2012/02/15 | Not Applicable | Completed |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| REMEDYREPACK INC. | 70518-2964 | ORAL | 750 mg in 1 1 | 3/12/2024 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1516 | INTRAVENOUS | 30 mg in 100 mL | 1/27/2024 | |
| IT3 Medical LLC | 70529-027 | INTRAVENOUS | 30 mg in 100 mL | 6/6/2018 | |
| Novel Laboratories, Inc. | 40032-090 | ORAL | 2.97 g in 274.31 g | 2/8/2023 | |
| Belcher Pharmaceuticals LLC | 62250-714 | ORAL | 40 meq in 15 mL | 10/5/2023 | |
| Sun Pharmaceutical Industries, Inc. | 63304-090 | ORAL | 750 mg in 1 1 | 1/10/2024 | |
| Proficient Rx LP | 71205-996 | ORAL | 750 mg in 1 1 | 7/1/2022 | |
| Par Pharmaceutical | 0603-1554 | ORAL | 1.5 g in 1.58 g | 3/31/2020 | |
| Baxter Healthcare Corporation | 24571-102 | INTRAVENOUS | 0.157 g in 1 L | 11/1/2018 | |
| Becton Dickinson and Company | 17271-710 | INTRAVENOUS | 30 mg in 100 mL | 3/20/2019 |
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 |
|---|---|---|---|---|---|
| Potassium Chloride Injection | 国药准字H20053971 | 化学药品 | 注射剂 | 10/18/2023 | |
| Potassium Chloride Injection | 国药准字H33021529 | 化学药品 | 注射剂 | 7/13/2020 | |
| Potassium Chloride Injection | 国药准字H32024860 | 化学药品 | 注射剂 | 6/30/2020 | |
| Potassium Chloride Injection | 国药准字H53020917 | 化学药品 | 注射剂 | 8/12/2020 | |
| Potassium Chloride Injection | 国药准字H65020288 | 化学药品 | 注射剂 | 12/9/2020 | |
| Potassium Chloride Injection | 国药准字H42020908 | 化学药品 | 注射剂 | 10/12/2022 | |
| Potassium Chloride Injection | 国药准字H20249638 | 化学药品 | 注射剂 | 12/1/2024 | |
| Potassium Chloride Injection | 国药准字H20013005 | 化学药品 | 注射剂 | 12/9/2019 | |
| Potassium Chloride Injection | 国药准字H32021915 | 化学药品 | 注射剂 | 7/7/2020 | |
| Potassium Chloride Injection | 国药准字H20247013 | 化学药品 | 注射剂 | 1/16/2024 |
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 |
|---|---|---|---|---|---|
| Active Elements Active 4.1 Tablets | 127005 | Medicine | A | 4/18/2006 | |
| B BRAUN COMPOUND SODIUM LACTATE 1000mL injection | 49330 | Medicine | A | 8/15/1994 | |
| BAXTER RINGERS SOLUTION injection 1000mL AHB2304 | 19443 | Medicine | A | 9/30/1991 | |
| BAXTER 0.224% POTASSIUM CHLORIDE and 5% GLUCOSE 1000mL injection AHB1174 | 19469 | Medicine | A | 9/30/1991 | |
| OLICLINOMEL N5-800 E 2000 mL IV emulsion for infusion with electrolytes bag | 141383 | Medicine | A | 9/4/2007 | |
| O.R.S. ORAL REHYDRATION SALTS oral powder sachet | 81381 | Medicine | A | 2/27/2002 | |
| Schuessler Tissue Salts General Tonic Comb 12 | 121322 | Medicine | A | 8/16/2005 | |
| Hydrate Orange | 321236 | Medicine | A | 8/2/2019 | |
| MOVIPREP ORANGE powder for oral solution sachet | 206448 | Medicine | A | 2/27/2013 | |
| Schuessler Tissue Salts Congestion Comb J | 120756 | Medicine | A | 7/21/2005 |