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
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/05/22 | Phase 4 | Not yet recruiting | |||
2025/02/12 | Phase 2 | Not yet recruiting | Joseph D. Tobias | ||
2024/03/07 | Phase 4 | Recruiting | |||
2023/05/11 | Phase 4 | Completed | Adam Fedyk, MD, FACS | ||
2023/03/16 | Not Applicable | Completed | |||
2023/03/02 | Phase 3 | Not yet recruiting | |||
2022/06/28 | Phase 4 | Recruiting | |||
2022/05/02 | Phase 3 | Completed | |||
2022/02/23 | Phase 3 | Recruiting | |||
2022/02/16 | Not Applicable | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Baxter Healthcare Corporation | 0338-0190 | IRRIGATION | 40 mg in 100 mL | 2/21/2014 | |
Zydus Pharmaceuticals USA Inc | 68382-398 | ORAL | 1500 mg in 1 1 | 11/30/2023 | |
Physicians Total Care, Inc. | 54868-4617 | ORAL | 20 meq in 1 1 | 9/5/2012 | |
Fresenius Kabi USA, LLC | 65219-153 | INTRAVENOUS | 1.49 g in 1000 mL | 3/2/2017 | |
Bryant Ranch Prepack | 63629-2620 | ORAL | 600 mg in 1 1 | 2/6/2024 | |
Carilion Materials Management | 68151-0609 | ORAL | 600 mg in 1 1 | 5/20/2015 | |
NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8399 | ORAL | 750 mg in 1 1 | 6/7/2021 | |
Lohxa | 70166-582 | ORAL | 1.5 g in 15 mL | 2/25/2021 | |
Zydus Pharmaceuticals (USA) Inc. | 68382-701 | ORAL | 750 mg in 1 1 | 12/17/2021 | |
Baxter Healthcare Corporation | 0338-0117 | INTRAVENOUS | 30 mg in 100 mL | 10/9/2019 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
No EMA approvals found for this drug. |
HSA Drug Approvals
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 |
---|---|---|---|---|---|
HIGHLY CONCENTRATED POTASSIUM CHLORIDE INJ (20MEQ) (BAXTER USA) | N/A | N/A | N/A | 3/15/2008 | |
RINGER'S INJ | N/A | otsuka pharmaceutical (h.k.) limited | N/A | N/A | 5/15/2008 |
LACTATED RINGER'S INJ | N/A | N/A | N/A | 5/17/1979 | |
ISOCOLAN POWDER FOR ORAL SOLUTION | N/A | N/A | N/A | 8/19/2024 | |
PLASMA-LYTE 148 AND GLUCOSE 5% W/V SOLUTION FOR INFUSION | N/A | N/A | N/A | 8/23/2024 | |
OLIMEL N9E EMULSION FOR INFUSION | N/A | N/A | N/A | 10/24/2013 | |
POTASSIUM CHLORIDE CONCENTRATE FOR SOLUTION FOR INFUSION 14.9% W/V | N/A | N/A | N/A | 10/23/2024 | |
KALINOR RETARD PROLONGED-RELEASE CAPSULES 600MG | N/A | N/A | N/A | 9/30/2024 | |
WIDA RL RINGER LACTATE INTRAVENOUS INFUSION | N/A | otsuka pharmaceutical (h.k.) limited | N/A | N/A | 10/30/2009 |
NAMIDA EYE-RUBY EYE DROPS | N/A | eng an trading company limited | N/A | N/A | 5/7/1996 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
---|---|---|---|---|---|
ACID CONCENTRATE RZ119C | genpharm ulc | N/A | Liquid - Haemodialysis | 3.355 G / L | 12/31/1995 |
ACID CONCENTRATE RO4137 | genpharm ulc | N/A | Liquid - Haemodialysis | 2.746 G / L | 12/31/1995 |
SELECTBAG ONE (AX 450 G) | Vantive ULC | 02415488 | Solution - Haemodialysis | 59.6 G / L | 4/21/2017 |
SB 1000 | renal systems, division of minntech corp. | 00678783 | Liquid - Haemodialysis | 5.5 G / L | 12/31/1985 |
POTASSIUM SR 600MG TABLETS | 02232701 | Tablet (Extended-Release) - Oral | 600 MG / TAB | N/A | |
POTASSIUM CHLORIDE INJECTION | baxter corporation | 02241679 | Solution - Intravenous | 40 mEq / 100 ML | 8/10/2000 |
POTASSIUM CHLORIDE BP - ADDITIVE FOR CONCENTRATED HAEMODIALYSIS SOLUTIONS | genpharm ulc | 02230681 | Powder - Haemodialysis | 12.5 G / VIAL | 6/18/1998 |
ACID CONCENTRATE RZ254C | genpharm ulc | 02178389 | Liquid - Haemodialysis | 5.032 G / L | 12/31/1995 |
PRISMASOL 2 | Vantive ULC | 02277441 | Solution - Intravenous
,
Haemodialysis | 0.157 G / L | 2/21/2006 |
POTASSIUM CHLORIDE 40 MEQ IN 5% DEXTROSE AND 0.45% SODIUM CHLORIDE | ICU Medical Canada Inc | 00603244 | Solution - Intravenous | 0.3 G / 100 ML | 12/31/1983 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
---|---|---|---|---|---|
No CIMA AEMPS (Spain) approvals found for this drug. |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Philippines FDA approvals found for this drug. |
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Saudi SFDA approvals found for this drug. |
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
---|---|---|---|---|---|
No Malaysia NPRA approvals found for this drug. |
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
---|---|---|---|---|---|
No UK EMC drug information found for this drug. |
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