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Potassium chloride

Generic Name
Potassium chloride
Brand Names
Bi-peglyte, Bss, Bss Ophthalmic Solution, Cardioplegic, Citrasate, Colyte, Dextrose and Electrolyte No. 75, Diphen, Eye Stream, Gavilyte-C, Gavilyte-G, Gavilyte-H and Bisacodyl, Gavilyte-N, Glycerolyte 57, Golytely, H.E.L.P.bicel, Hemosate Ultra, Ionosol-MB, Isolyte P, Isolyte S, Isolyte S pH 7.4, Isoplate, K 45, K-tab, Klor-con, Lactated Ringers, Moviprep, Naturalyte, Normosol-R, Nulytely, Nxstage Pureflow, Olimel, Peglyte, Periolimel, Phoxillum, Physiolyte, Physiosol, Plasma-lyte, Plasma-lyte 148, Plasma-lyte 148 In 5 % Dextrose, Plasma-lyte R, Plasmalyte A, Plegisol, Plenvu, Pokonza, Prismasol, Procalamine 3, Ringers, Selectbag One, Suflave, Tis-U-sol
Drug Type
Small Molecule
Chemical Formula
ClK
CAS Number
7447-40-7
Unique Ingredient Identifier
660YQ98I10

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

Published: Aug 1, 2025

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.

Continue reading the full research report

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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HSA Drug Approvals

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NMPA Drug Approvals

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No NMPA approvals found for this drug.

PPB Drug Approvals

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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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Company
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Pharmaceutical Form
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Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

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Saudi SFDA Drug Approvals

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Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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