Potassium citrate

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

Title	Posted	Study ID	Phase	Status	Sponsor
Impact of Sodium Bicarbonate on 24-hour Urine Parameters in Hypocitriuric and Uric Acid Stone Formers	2024/03/28	NCT06335537	Phase 1	Recruiting	University of California, Irvine
Hydroxycitrate: A Novel Therapy for Calcium Phosphate Urinary Stones	2023/08/21	NCT06003348	Phase 4	Recruiting	University of Texas Southwestern Medical Center
Potassium Citrate and Crystal Light Lemonade	2022/05/25	NCT05389995	Not Applicable	Recruiting	Northwestern University
Comparing Alkalinizing Agents Efficacy on Stone Risk in Patients on a Metabolically Controlled Diet	2020/12/03	NCT04651088	Early Phase 1	Not yet recruiting	University of Texas Southwestern Medical Center
Study Evaluating Patients With Cystinuria and Efficacy and Safety Exploratory Study in the Youngest Children	2019/11/01	NCT04147871	Phase 2	Not yet recruiting	Advicenne Pharma
Study Evaluating Patients With Cystinuria	2019/10/24	NCT04137978	Phase 2	Withdrawn	Advicenne Pharma
Extension Study in Primary Distal Renal Tubular Acidosis	2019/02/05	NCT03831152	Phase 3	Withdrawn	Advicenne Pharma
Dietary Counseling or Potassium Supplement to Increase Potassium Intake in Patients With High Blood Pressure	2019/01/18	NCT03809884	Phase 3	Completed	Ottawa Hospital Research Institute
Study Evaluating Subjects With Distal Renal Tubular Acidosis	2018/08/23	NCT03644706	Phase 3	Terminated	Advicenne Pharma
Study to Assess the Efficacy and Safety of Oral Potassium Citrate on the Prevention of Nephrocalcinosis in Extreme Premature	2012/12/27	NCT01756547	Phase 3	UNKNOWN	Juan A. Arnaiz

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
POTASSIUM CITRATE	Ascent Pharmaceuticals Inc	43602-399	ORAL	5 meq in 1 1	1/18/2021
Potassium Citrate	Upsher-Smith Laboratories, LLC	0245-0070	ORAL	5 meq in 1 1	8/11/2022
Potassium Citrate	Zydus Pharmaceuticals (USA) Inc.	68382-538	ORAL	15 meq in 1 1	10/3/2023
Potassium Citrate	American Health Packaging	68084-850	ORAL	10 meq in 1 1	9/13/2022
Potassium Citrate	Actavis Pharma, Inc.	0591-2729	ORAL	10 meq in 1 1	6/1/2022
POTASSIUM CITRATE	Ascent Pharmaceuticals Inc	43602-401	ORAL	15 meq in 1 1	1/18/2021
TRICITRATES	PAI Holdings, LLC	0121-0677	ORAL	550 mg in 5 mL	4/10/2023
POTASSIUM CITRATE EXTENDED RELEASE	Bryant Ranch Prepack	72162-2476	ORAL	5 meq in 1 1	5/2/2025
POTASSIUM CITRATE	Bryant Ranch Prepack	72162-2121	ORAL	15 meq in 1 1	1/19/2022
POTASSIUM CITRATE	XLCare Pharmaceuticals, Inc.	72865-191	ORAL	5 meq in 1 1	1/21/2022

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
UROCIT-K TABLET 1080 mg	MISSION PHARMACAL COMPANY	SIN08734P	TABLET	1080 mg	5/27/1996
POTASSIUM CITRATE MIXTURE BP	ICM PHARMA PTE. LTD.	SIN06732P	SOLUTION	30% w/v	12/19/1991
POTCIT MIXTURE	BEACONS PHARMACEUTICALS PTE LTD	SIN05148P	SOLUTION	1 g/5 ml	10/16/1990

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
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
ENDURA LOW CARB HYDRATION COCONUT	330951	Metagenics (Aust) Pty Ltd	Medicine	A	3/10/2020
HYDRAlyte Ready to Use Orange Flavoured Electrolyte Solution	90732	Care Pharmaceuticals Pty Ltd	Medicine	A	8/26/2002
Hydralyte Orange Electrolyte Powder (Tub)	292256	The Hydration Pharmaceuticals Trust	Medicine	A	7/31/2017
Hydralyte Orange Electrolyte Ice Blocks	229731	The Hydration Pharmaceuticals Trust	Medicine	A	10/24/2014
Quality Health Australia Daily Multi	404880	Pharmacare Laboratories Pty Ltd	Medicine	A	2/15/2023
Natal Care	395834	Biomedica Nutraceuticals Pty Ltd	Medicine	A	9/12/2022
Isotonix Calcium Plus	396040	Market Australia Inc	Medicine	A	9/16/2022
ElementAll Diet	447331	Factors Group Australia Pty Ltd	Medicine	A	5/1/2024
Liquid I.V. Hydration Multiplier Passionfruit	423890	Unilever Australia Limited	Medicine	A	10/4/2023
Rehydraid Orange Slushie	414391	Redland Pharmaceuticals Pty Ltd	Medicine	A	7/24/2023

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
REHYDRALYTE	ross laboratories, division of abbott laboratories ltd.	00763195	Liquid - Oral	2.04 MG / ML	12/31/1988
FORMULA NO. 2 PLUS K LIQ	golden pride/rawleigh	02048256	Liquid - Oral	19.5 MG / ML	12/31/1993
LYTREN RHS LIQ	mead johnson nutritionals	00841803	Liquid - Oral	217 MG / 100 ML	12/31/1990
POWER C PLUS	sportscience labs inc.	00540951	Tablet (Extended-Release) - Oral	60 MG	12/31/1980
UROCIT-K	MISSION PHARMACAL COMPANY	02353997	Tablet (Extended-Release) - Oral	1080 MG	2/11/2011
UROCIT-K	MISSION PHARMACAL COMPANY	01914022	Tablet (Extended-Release) - Oral	540 MG	1/1/1995
LYTREN	mead johnson nutritionals	00654957	Liquid - Oral	270 MG / 100 ML	12/31/1985
SUPER MULTI-TAB	gahler enterprises ltd.	02137801	Tablet - Oral	10 MG	10/30/1994
NEO PECTOL	neolab inc	00147656	Syrup - Oral	975 MG / 30 ML	12/31/1951
B6 PLUS TAB	vita health products inc	00393347	Tablet - Oral	50 MG	12/31/1979

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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