POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (potassium chloride)
This intravenous medication is indicated as a source of electrolytes and water for the treatment and prevention of potassium deficiency (hypokalemia) when oral replacement is not feasible or is inadequate. It serves to maintain or restore potassium levels and provide fluid and sodium chloride for electrolyte balance in patients with restricted oral intake or excessive losses.
How POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Works
Potassium is the principal intracellular cation, essential for maintaining intracellular tonicity and the electrochemical gradient across cell membranes. It is a critical cofactor in nerve impulse transmission, the contraction of cardiac, skeletal, and smooth muscle, and the maintenance of normal renal function. This solution provides exogenous potassium to restore the gradient between intracellular and extracellular concentrations, while the sodium chloride component assists in maintaining extracellular fluid volume and osmotic pressure.
Details
- Status
- Prescription
- First Approved
- 2008-09-10
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Approval History
What POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Treats
2 indicationsPOTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is approved for 2 conditions since its original approval in 2008. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypokalemia
- Metabolic Alkalosis
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% 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| NCT04316611 POTACREH | APHP180577 2019-002544-24 | Ph 2 | withdrawn | Potassium Chloride in Out-of-hospital Cardiac Arrest Due to Refractory Ventricular Fibrillation |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 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER FDA Label Details
Indications & Usage
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is indicated for the treatment of Hypokalemia; Metabolic Alkalosis.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.