Overview
Potassium citrate (also known as tripotassium citrate) is a potassium salt of citric acid. It is a white, hygroscopic crystalline powder. It is odorless with a saline taste. It contains 38.3% potassium by mass. In the monohydrate form it is highly hygroscopic and deliquescent. Potassium citrate is used to treat a kidney stone condition called renal tubular acidosis. Potassium Citrate is indicated also for the management of Hypocitraturic calcium oxalate nephrolithiasis.
Indication
For the management of renal tubular acidosis, hypocitraturic calcium oxalate nephrolithiasis, and uric acid lithiasis with or without calcium stones.
Associated Conditions
- Bowel preparation therapy
- Constipation
- Hypocitraturic calcium oxalate nephrolithiasis
- Kidney Stones
- Metabolic Acidosis
- Renal tubular acidosis
- Uremia
- Uric Acid Nephrolithiasis
- Chronic metabolic acidosis
Clinical Trials
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Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2009/06/04 | Phase 2 | Completed | |||
2007/07/31 | Phase 3 | Completed | Kantonsspital Baselland Bruderholz | ||
2006/07/27 | Phase 4 | Completed | |||
2005/07/19 | Not Applicable | Withdrawn | Children's Mercy Hospital Kansas City | ||
1999/10/19 | Phase 3 | Completed | National Center for Research Resources (NCRR) |
FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| ATLANTIC BIOLOGICALS CORP. | 17856-0677 | ORAL | 550 mg in 5 mL | 9/26/2018 | |
| Zydus Lifesciences Limited | 65841-536 | ORAL | 5 meq in 1 1 | 10/3/2023 | |
| REMEDYREPACK INC. | 70518-3160 | ORAL | 10 meq in 1 1 | 3/13/2024 | |
| Bryant Ranch Prepack | 71335-1706 | ORAL | 10 meq in 1 1 | 2/25/2022 | |
| Bryant Ranch Prepack | 63629-8759 | ORAL | 10 meq in 1 1 | 6/1/2022 | |
| Upsher-Smith Laboratories, LLC | 0245-0071 | ORAL | 10 meq in 1 1 | 8/11/2022 | |
| Strides Pharma Inc. | 42543-408 | ORAL | 15 meq in 1 1 | 5/25/2023 | |
| Mission Pharmacal Company | 0178-0615 | ORAL | 15 meq in 1 1 | 1/8/2024 | |
| Zydus Pharmaceuticals (USA) Inc. | 68382-536 | ORAL | 5 meq in 1 1 | 10/3/2023 | |
| Bryant Ranch Prepack | 72162-2122 | ORAL | 5 meq in 1 1 | 1/19/2022 |
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 Citrate Granules | 国药准字H20065593 | 化学药品 | 颗粒剂 | 7/23/2020 | |
| Potassium Citrate Granules | 国药准字H20054682 | 化学药品 | 颗粒剂 | 5/22/2020 | |
| Potassium Citrate Granules | 国药准字H20074119 | 化学药品 | 颗粒剂 | 4/12/2022 | |
| Potassium Citrate Granules | 国药准字H10970220 | 化学药品 | 颗粒剂 | 3/12/2020 | |
| Potassium Citrate Granules | 国药准字H22024249 | 化学药品 | 颗粒剂 | 4/8/2020 |
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 |
|---|---|---|---|---|---|
| Everyday Hydration Mixed Berry | 408802 | Medicine | A | 5/11/2023 | |
| Essential Health Men's High Potency Multivitamins | 343036 | Medicine | A | 9/5/2020 | |
| ENDURA LOW CARB HYDRATION GRAPEBERRY | 330953 | Medicine | A | 3/10/2020 | |
| Mega B and Electrolytes | 333489 | Medicine | A | 4/6/2020 | |
| Rehydraid Orange Electrolyte Ice Blocks | 321747 | Medicine | A | 8/14/2019 | |
| ENDURA PERFORMANCE HYDRATION ORANGE | 375078 | Medicine | A | 9/22/2021 | |
| Pure Children’s Essentials | 371280 | Medicine | A | 7/19/2021 | |
| AlkaMin Essentials | 398358 | Medicine | A | 10/25/2022 | |
| METAGENICS CALMX TROPICAL | 365752 | Medicine | A | 5/13/2021 | |
| Colgate Sensitive Enamel Protect Toothpaste | 165215 | Medicine | A | 9/12/2009 |
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