POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (potassium chloride) · OTSUKA ICU MEDCL
Potassium Chloride in Sodium Chloride Injection is indicated for the treatment of potassium deficiency (hypokalemia) in patients for whom oral replacement therapy is not feasible, insufficient, or inappropriate. It is used to treat existing potassium depletion and to prevent deficiency in patients at risk, such as those with severe potassium loss or those requiring parenteral nutrition.
How POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Works
Potassium is the principal intracellular cation of most body tissues and is essential for various physiological processes. It is critical for maintaining intracellular tonicity, the transmission of nerve impulses, the contraction of cardiac, skeletal, and smooth muscle, and the maintenance of normal renal function. This medication restores potassium levels to maintain the vital electrical gradient between the intracellular and extracellular compartments, which is necessary for normal cellular function and electrical activity.
Details
- Status
- Prescription
- First Approved
- 1988-10-17
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Approval History
What POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Treats
2 indicationsPOTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is approved for 2 conditions since its original approval in 1988. These indications span multiple therapeutic areas including oncology, immunology, and more.
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Competitive Set
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Indication competitors
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07238400 CARDAMOM | 2025P001799 R01HL181150 | Ph 2 | recruiting | Cardiac Effects of Mineralocorticoid Receptor Antagonism After Preeclampsia |
| NCT04316611 POTACREH | APHP180577 2019-002544-24 | Ph 2 | withdrawn | Potassium Chloride in Out-of-hospital Cardiac Arrest Due to Refractory Ventricular Fibrillation |
| NCT02450773 | 201501157 | Ph 2 | withdrawn | Prevention of Severe Postpartum Hypertension |
| NCT03627130 NITRATE-CIN | 18/1 | Ph 2 | completed | The Use of Inorganic Nitrate for the Prevention of Contrast-induced Nephropathy |
| NCT03483051 PULSE-AS results posted | 828994 | Ph 2 | completed | Targeting Pulsatile Load to Increase Exercise Capacity and Quality of Life After Aortic Valve Replacement for Severe Aortic Stenosis (PULSE AS) |
| NCT01074918 | 012007-080 | Ph 1, Ph 2 | withdrawn | Potassium-Magnesium Citrate as a Blood Pressure Lowering Agent in Hypertensive Patients |
| NCT01818583 | AK-01 | Ph 4 | completed | Potassium Infusion for Conversion of Atrial Fibrillation/-Flutter |
| NCT01085071 GRIP-COMPASS | GRIP-COMPASS trial | Ph 4 | completed | Comparison of Two Potassium Targets Within the Normal Range in Intensive Care Patients |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
Potassium Chloride Extended-Release Tablets are indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium Chloride Extended-Release Tablets are a potassium salt, indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.