Potassium chloride

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

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
The Effect of Preoperative Intravenous Fluid Bolus on Post-induction Hypotension in Elective Cystoscopies.	2025/05/22	NCT06985654	Phase 4	Not yet recruiting	University of Missouri-Columbia
Hypertonic Saline in Posterior Spinal Fusion	2025/02/12	NCT06822374	Phase 2	Not yet recruiting	Joseph D. Tobias
Bowel Preparation for Colonoscopy Among Individuals With Crohn's and Ulcerative Colitis Disease.	2024/03/07	NCT06298461	Phase 4	Recruiting	University of Manitoba
The Evaluation of Balanced Salt Solution During Cataract Surgery	2023/05/11	NCT05853978	Phase 4	Completed	Adam Fedyk, MD, FACS
Aggressive Intravenous Hydration With Lactated Ringer's Solution for Prevention of Post-ESWL Pancreatitis	2023/03/16	NCT05772234	Not Applicable	Completed	Changhai Hospital
Balanced Multi-Electrolyte Solution Versus Saline Trial for Diabetic KetoAcidosis	2023/03/02	NCT05752279	Phase 3	Not yet recruiting	The George Institute
A Trial to Compare Efficacy and Tolerability of Plenvu® and Picoprep® as Cleansing Agents Before Colonoscopy	2022/06/28	NCT05436054	Phase 4	Recruiting	Aalborg University Hospital
Using Vasopressor Medication to Support Blood Pressure During Intubation Procedure	2022/05/02	NCT05355974	Phase 3	Completed	Wright State University
A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects	2022/02/23	NCT05253209	Phase 3	Recruiting	Asklepion Pharmaceuticals, LLC
Effect of Low-volume (1L) vs Intermediate-volume (2L) Bowel Preparation on Cost-effectiveness and Quality of Life	2022/02/16	NCT05242562	Not Applicable	Completed	Radboud University Medical Center

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
TIS-U-SOL	Baxter Healthcare Corporation	0338-0190	IRRIGATION	40 mg in 100 mL	2/21/2014
Potassium Chloride	Zydus Pharmaceuticals USA Inc	68382-398	ORAL	1500 mg in 1 1	11/30/2023
Potassium Chloride	Physicians Total Care, Inc.	54868-4617	ORAL	20 meq in 1 1	9/5/2012
Potassium Chloride in Dextrose and Sodium Chloride	Fresenius Kabi USA, LLC	65219-153	INTRAVENOUS	1.49 g in 1000 mL	3/2/2017
Potassium Chloride	Bryant Ranch Prepack	63629-2620	ORAL	600 mg in 1 1	2/6/2024
Potassium Chloride	Carilion Materials Management	68151-0609	ORAL	600 mg in 1 1	5/20/2015
Potassium Chloride Extended-release	NCS HealthCare of KY, LLC dba Vangard Labs	0615-8399	ORAL	750 mg in 1 1	6/7/2021
Potassium Chloride	Lohxa	70166-582	ORAL	1.5 g in 15 mL	2/25/2021
POTASSIUM CHLORIDE	Zydus Pharmaceuticals (USA) Inc.	68382-701	ORAL	750 mg in 1 1	12/17/2021
Lactated Ringers	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

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP	B BRAUN MEDICAL INDUSTRIES SDN BHD, B. Braun Melsungen AG, B. Braun Medical SA	SIN06429P	INJECTION	0.04 g/100 ml	7/8/1991
STERILE POTASSIUM CHLORIDE CONCENTRATE INJECTION 7.45%	B BRAUN MEDICAL INDUSTRIES SDN BHD	SIN07923P	INJECTION	7.45 g/100 ml	11/23/1994
POTASSIUM CHLORIDE INJECTION - HIGHLY CONCENTRATED (100 mEq/l)	Baxter Healthcare Corporation, Baxter Healthcare Philippines Inc.	SIN11532P	INJECTION	746 mg/100 ml	5/29/2001
POTASSIUM CHLORIDE INJECTION - HIGHLY CONCENTRATED (400 mEq/l)	Baxter Healthcare Corporation, Baxter Healthcare Philippines Inc.	SIN11566P	INJECTION	1.49 g/50 ml	6/21/2001
POTASSIUM CHLORIDE MIXTURE 500 mg/5 ml	BEACONS PHARMACEUTICALS PTE LTD	SIN08437P	SOLUTION	500 mg/5 ml	11/11/1995
POTASSIUM CHLORIDE INJECTION - HIGHLY CONCENTRATED (200 mEq/l)	Baxter Healthcare Corporation, Baxter Healthcare Philippines Inc.	SIN11567P	INJECTION	746 mg/50 ml	6/21/2001
POTASSIUM CHLORIDE TABLETS (SLOW-RELEASE) 600 mg (YELLOW)	BEACONS PHARMACEUTICALS PTE. LTD.	SIN07447P	TABLET	600 mg	6/21/1993
Potassium Chloride 0.15% in Dextrose 5% and Sodium Chloride 0.45% Injection USP	B.Braun Medical Inc. (Parametric Release)	SIN13887P	INFUSION, SOLUTION	1.5g/1000ml	11/12/2010
SMOFKABIVEN EXTRA NITROGEN EMULSION FOR INFUSION	Fresenius Kabi AB, Site Uppsala	SIN16135P	INJECTION, EMULSION	2.3g/1000ml	3/24/2021
Potassium Chloride 0.22% in Dextrose 5% and Sodium Chloride 0.45% Injection USP	B.Braun Medical Inc. (Parametric Release)	SIN13888P	INFUSION, SOLUTION	2.2g/1000ml	11/12/2010

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
Potassium Chloride for Injection	辽宁药联制药有限公司	国药准字H20061217	化学药品	注射剂	9/2/2020
Potassium Chloride for Injection	辽宁药联制药有限公司	国药准字H20051693	化学药品	注射剂	9/2/2020
Potassium Chloride for Injection	山西普德药业有限公司	国药准字H20060259	化学药品	注射剂	3/9/2020
Potassium Chloride for Injection	海南美兰史克制药有限公司	国药准字H20052089	化学药品	注射剂	9/2/2020
Potassium Chloride for Injection	山西振东泰盛制药有限公司	国药准字H20052072	化学药品	注射剂	7/28/2020
Potassium Chloride for Injection	河北爱尔海泰制药有限公司	国药准字H20052009	化学药品	注射剂	11/6/2020
Potassium Chloride Injection	成都倍特药业股份有限公司	国药准字H32022330	化学药品	注射剂(注射液)	9/27/2020
Potassium Chloride Injection	遂成药业股份有限公司	国药准字H20247305	化学药品	注射剂	12/5/2024
Potassium Chloride Injection	南京赛瑞谱顿制药有限公司	国药准字H20253715	化学药品	注射剂	3/25/2025
Potassium Chloride Injection	北京布霖生物科技有限公司	国药准字H20253478	化学药品	注射剂	2/25/2025

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
HIGHLY CONCENTRATED POTASSIUM CHLORIDE INJ (20MEQ) (BAXTER USA)	N/A	Baxter Healthcare Ltd	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	LUEN CHEONG HONG	N/A	N/A	5/17/1979
ISOCOLAN POWDER FOR ORAL SOLUTION	N/A	TREASURE MOUNTAIN DEVELOPMENT COMPANY LIMITED	N/A	N/A	8/19/2024
PLASMA-LYTE 148 AND GLUCOSE 5% W/V SOLUTION FOR INFUSION	N/A	Baxter Healthcare Ltd	N/A	N/A	8/23/2024
OLIMEL N9E EMULSION FOR INFUSION	N/A	Baxter Healthcare Ltd	N/A	N/A	10/24/2013
POTASSIUM CHLORIDE CONCENTRATE FOR SOLUTION FOR INFUSION 14.9% W/V	N/A	B BRAUN MEDICAL SA	N/A	N/A	10/23/2024
KALINOR RETARD PROLONGED-RELEASE CAPSULES 600MG	N/A	HIND WING COMPANY LIMITED	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

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
Trainade Lemon Lime	380939	SB Functional Health Group Pty Ltd	Medicine	A	12/16/2021
MOVICOL JUNIOR CHOCOLATE FLAVOUR powder for oral solution sachet	207698	Norgine Pty Ltd	Medicine	A	4/3/2013
SMOFKABIVEN amino acids 5.1% / lipids 3.8% / glucose 12.7% / electrolytes 0.7% emulsion for intravenous infusion bag 1970 mL	180546	Fresenius Kabi Australia Pty Ltd	Medicine	A	1/9/2012
OLICLINOMEL N4-550 E 1000 mL IV emulsion for infusion with electrolytes bag	136599	Baxter Healthcare Pty Ltd	Medicine	A	9/4/2007
OLICLINOMEL N4-550 E 2500 mL IV emulsion for infusion with electrolytes bag	141396	Baxter Healthcare Pty Ltd	Medicine	A	9/4/2007
OLIMEL N5-860E Emulsion for intravenous infusion	197417	Baxter Healthcare Pty Ltd	Medicine	A	8/9/2013
MACROVIC FLAVOURED JUNIOR powder for oral solution sachet	220580	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	2/27/2014
MACROVIC JUNIOR powder for oral solution sachet	220582	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	2/27/2014
Hydralyte Tropical Flavoured Effervescent Electrolyte Tablets	370691	Care Pharmaceuticals Pty Ltd	Medicine	A	7/7/2021
SMOFKABIVEN LOW OSMO amino acids 2.5%, electrolytes 0.4%, lipids 3.5% & glucose 6.8% emulsion for intravenous infusion 2500 mL biofine bag	329619	Fresenius Kabi Australia Pty Ltd	Medicine	A	8/27/2020

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