PROTOPAM CHLORIDE
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
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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.
PROTOPAM CHLORIDE FDA Label Details
ProIndications & 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.