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.
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
Research Report
A Comprehensive Monograph on Potassium Chloride (DB00761): From Physicochemical Properties to Clinical Application and Safety
Introduction and Overview
Executive Summary
Potassium chloride (KCl) is a simple metal halide salt that serves as a cornerstone medication for the treatment and prevention of hypokalemia (low blood potassium).[1] Despite its fundamental chemical nature, its profound physiological importance and narrow therapeutic index classify it as a high-risk medication requiring meticulous clinical management. As the principal intracellular cation, potassium is indispensable for numerous physiological processes, including nerve impulse transmission, muscle contraction (cardiac, skeletal, and smooth), and the maintenance of intracellular tonicity and renal function.[1] The administration of potassium chloride, while essential for correcting deficiencies, carries significant risks, most notably life-threatening hyperkalemia and severe gastrointestinal injury.[3] This report provides an exhaustive analysis of potassium chloride, synthesizing data on its chemical properties, pharmacology, clinical use, safety profile, and regulatory landscape to serve as a definitive resource for clinicians and researchers.
Scope and Objectives
This monograph covers the full spectrum of knowledge regarding potassium chloride, from its basic chemical identifiers (CAS 7447-40-7, DrugBank ID DB00761) to its complex clinical applications.[1] The objective is to provide a nuanced, integrated understanding of how its properties influence its therapeutic use and associated risks. The analysis reveals a central paradox: the drug's chemical simplicity belies its clinical complexity. This report will deconstruct this paradox by systematically connecting its physicochemical characteristics to its formulation science, its physiological role to its pharmacodynamic effects, and its pharmacokinetic profile to its stringent safety requirements.
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 |
---|---|---|---|---|---|
Physicians Total Care, Inc. | 54868-3671 | ORAL | 10 meq in 1 1 | 9/5/2012 | |
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 | |
Martin & Pleasance Pty Ltd | 84999-029 | ORAL | 6 [hp_X] in 1 1 | 9/9/2025 | |
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 | |
Laboratorios Alfa SRL | 72483-202 | INTRAVENOUS | 30 mg in 100 mL | 8/13/2025 |
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 |
---|---|---|---|---|---|
No NMPA approvals found for this drug. |
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 |
Health Canada Drug Approvals
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Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ROYCHLOR - 10% - LIQ ORL | waymar pharmaceuticals inc. | 02166372 | Liquid - Oral | 10 % | 12/31/1996 |
ACID CONCENTRATE BP RO4151 | genpharm ulc | 02240330 | Liquid - Haemodialysis | 5.4914 G / L | 9/16/1999 |
ACID CONCENTRATE RZ265C | genpharm ulc | 02230081 | Liquid - Haemodialysis | 5.032 G / L | 1/29/1997 |
ACID CONCENTRATE RO4983 | genpharm ulc | 00897825 | Liquid - Haemodialysis | 2.746 G / L | 12/31/1989 |
SELECTBAG ONE (AX 350 G) | Vantive ULC | 02415526 | Solution - Haemodialysis | 44.7 G / L | 1/4/2016 |
SLO-POT | biomed pharma | 00554308 | Tablet (Extended-Release) - Oral | 600 MG | 12/31/1982 |
POTASSIUM CHLORIDE BP - ADDITIVE FOR CONCENTRATED HAEMODIALYSIS SOLUTIONS | genpharm ulc | 02230680 | Powder - Haemodialysis | 13 G / VIAL | 6/18/1998 |
POTASSIUM CHLORIDE FOR HEMODIALYSIS 7.55 | chief medical supplies ltd | 02529793 | Powder For Solution - Haemodialysis | 7.55 G / VIAL | 10/3/2022 |
POTASS CHLORIDE 10MEQ IN 5% DEXTROSE INJ USP | baxter corporation | 00786187 | Solution - Intravenous | 75 MG / 100 ML | 12/31/1990 |
TIS-U-SOL SOLUTION | baxter corporation | 00800007 | Liquid - Irrigation | 40 MG / 100 ML | 12/31/1990 |
CIMA AEMPS Drug Approvals
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Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
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No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
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Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
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No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
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UK EMC Drug Information
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Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
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