MedPath

Potassium

Generic Name
Potassium
Drug Type
Small Molecule
Chemical Formula
K
CAS Number
7440-09-7
Unique Ingredient Identifier
RWP5GA015D

Overview

Potassium is an essential nutrient, like Calcium and Magnesium. It was identified as a shortfall nutrient by the 2015-2020 Advisory Committee of Dietary Guidelines for Americans. Many conditions and diseases interfere with normal body potassium balance, and underconsumption of potassium is one example. Hypokalemia (low potassium) or hyperkalemia (high potassium) may result, manifesting as various signs and symptoms. Some examples of potassium-related complications include life-threatening arrhythmia, neuromuscular dysfunction, diarrhea, nausea, and vomiting. Various pharmacological preparations have been formulated to replenish potassium. They are available in an assortment of tablet, injection, and other forms, depending on the setting and condition being treated. Potassium is often a key ingredient for intravenous fluids, given to patients in clinical settings for rehydration, nutrition, and replenishment of electrolytes. Examples of potassium formulations include potassium citrate, potassium chloride, and potassium with dextrose and sodium chloride.

Background

Potassium is an essential nutrient, like Calcium and Magnesium. It was identified as a shortfall nutrient by the 2015-2020 Advisory Committee of Dietary Guidelines for Americans. Many conditions and diseases interfere with normal body potassium balance, and underconsumption of potassium is one example. Hypokalemia (low potassium) or hyperkalemia (high potassium) may result, manifesting as various signs and symptoms. Some examples of potassium-related complications include life-threatening arrhythmia, neuromuscular dysfunction, diarrhea, nausea, and vomiting. Various pharmacological preparations have been formulated to replenish potassium. They are available in an assortment of tablet, injection, and other forms, depending on the setting and condition being treated. Potassium is often a key ingredient for intravenous fluids, given to patients in clinical settings for rehydration, nutrition, and replenishment of electrolytes. Examples of potassium formulations include potassium citrate, potassium chloride, and potassium with dextrose and sodium chloride.

Indication

General uses of potassium Potassium is indicated to treat a variety of conditions. Firstly, it used to replenish potassium that has been depleted by conditions including but not limited to malabsorption, decreased intake, or excess sodium intake. The causes of potassium deficiency are numerous. The following indications for potassium are not comprehensive, but include the main indications for which this nutrient is used. Various products and preparations contain potassium. Potassium chloride Potassium chloride is one of the main preparations of potassium used in a clinical setting. The oral solution is indicated for the prevention and treatment of hypokalemia presenting with or without metabolic alkalosis, in patients who have failed conservative management with potassium-rich foods or diuretic dose titrations. The injection form of potassium chloride is indicated to replenish potassium in patients who are not feasible candidates for oral potassium. Highly concentrated potassium is intended for the treatment of potassium deficiency in fluid restricted individuals who cannot tolerate fluid volumes normally associated with injected potassium solutions that contain lower concentrations. Finally, the extended-release tablet preparation of potassium chloride is used to treat hypokalemia with or without metabolic alkalosis, to treat digitalis intoxication, and to manage patients with hypokalemic familial periodic paralysis. It is also used in the prevention of hypokalemia in those who are at a high risk of negative clinical outcomes if hypokalemia occurs; patients on digitalis or those with cardiac arrhythmias would be at particular risk of negative outcomes. Potassium chloride with dextrose and sodium chloride This liquid preparation is is indicated in a clinical setting as a source of water, calories and electrolytes. Potassium acetate solution is meant as an alternative to potassium chloride, replenishing potassium and added to large volume infusion fluids for intravenous injection. Potassium citrate The potassium citrate preparation is used for the management of renal tubular acidosis (RTA) with calcium stones (nephrolithiasis); calcium oxalate stones by any cause, and uric acid nephrolithiasis (with or without calcium stones). This regimen also includes adequate water intake (leading to a urine out put of 2 L/day or more) and sodium restriction.

Associated Conditions

  • Caloric Intake
  • Electrolyte and fluid balance conditions
  • Hydration
  • Hypokalemia
  • Potassium

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
2025/06/18
Phase 1
Not yet recruiting
2025/05/13
Phase 4
Recruiting
2025/02/11
Phase 1
Not yet recruiting
2024/12/24
Not Applicable
Completed
University of Modena and Reggio Emilia
2024/08/20
Phase 4
Recruiting
Shanghai Jiao Tong University School of Medicine
2024/08/20
Phase 4
Recruiting
Shanghai Jiao Tong University School of Medicine
2024/07/26
Phase 4
Active, not recruiting
Xijing Hospital of Digestive Diseases
2024/06/21
Not Applicable
Recruiting
National Aeronautics and Space Administration (NASA)
2024/05/21
Phase 2
Recruiting
2024/01/31
N/A
Completed

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Baxter Healthcare Corporation
0338-1023
INTRAVENOUS
2000000 [iU] in 50 mL
7/18/2016
Baxter Healthcare Corporation
0338-1021
INTRAVENOUS
1000000 [iU] in 50 mL
7/18/2016
Athenex Pharmaceutical Division, LLC.
70860-127
INTRAVENOUS
20000000 [iU] in 1 1
3/5/2024
King Bio Inc.
57955-2819
ORAL
10 [hp_X] in 59 mL
5/20/2025
Roerig
0049-0530
INTRAVENOUS
20000000 [iU] in 1 1
12/1/2022
WG Critical Care, LLC
44567-311
INTRAVENOUS, INTRAMUSCULAR
5000000 [iU] in 1 1
9/16/2021
BM Private Limited
85816-1031
ORAL
6 [hp_X] in 60 mg
6/20/2025
Roerig
0049-0520
INTRAVENOUS, INTRAMUSCULAR, INTRAPLEURAL, INTRATHECAL
5000000 [iU] in 1 1
12/1/2022
King Bio Inc.
57955-2830
ORAL
10 [hp_X] in 59 mL
5/20/2025
Roerig
0049-0420
INTRAVENOUS, INTRAMUSCULAR, INTRAPLEURAL, INTRATHECAL
5000000 [iU] in 1 1
12/1/2022

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
No HSA approvals found for this drug.

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

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