PROTOPAM CHLORIDE (pralidoxime chloride) · Baxter
PROTOPAM Chloride is an antidote indicated for the treatment of poisoning caused by organophosphate pesticides and chemicals, including nerve agents. It is also utilized to manage overdosage of anticholinesterase medications used in the treatment of myasthenia gravis. The drug is primarily used to address clinical manifestations such as muscle weakness and respiratory depression in affected patients.
How PROTOPAM CHLORIDE Works
Pralidoxime chloride is a cholinesterase reactivator. It works by displacing the phosphate group from the active site of the acetylcholinesterase enzyme that has been inhibited by an organophosphate pesticide or nerve agent. This restores the enzyme's ability to hydrolyze acetylcholine, thereby reversing the neuromuscular blockade and cholinergic crisis. The drug is most effective when administered before the enzyme-inhibitor complex undergoes "aging," a chemical process that renders the enzyme-inhibitor bond permanent.
Details
- Status
- Prescription
- First Approved
- 1964-03-11
- Routes
- INJECTION, ORAL
- Dosage Forms
- INJECTABLE, TABLET
PROTOPAM CHLORIDE Approval History
What PROTOPAM CHLORIDE Treats
3 indicationsPROTOPAM CHLORIDE is approved for 3 conditions since its original approval in 1964. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Organophosphate Poisoning
- Anticholinesterase Overdose
- Myasthenia Gravis
PROTOPAM CHLORIDE Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
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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Active Pipeline
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Trial Timeline
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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.
PROTOPAM CHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)PROTOPAM Chloride is indicated as an antidote: 1. In the treatment of poisoning due to those pesticides and chemicals (e.g., nerve agents) of the organophosphate class which have anticholinesterase activity and 2. In the control of overdosage by anticholinesterase drugs used in the treatment of myasthenia gravis. The principal indications for the use of PROTOPAM Chloride are muscle weakness and respiratory depression. In severe poisoning, respiratory depression may be due to muscle weakness.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.