pralidoxime chloride

FDA Drug Profile — Protopam Chloride

Drug Details

Generic Name
pralidoxime chloride
Brand Names
Protopam Chloride
Application Number
NDA014134
Sponsor
Baxter Healthcare Corporation
NDC Codes
1
Dosage Forms
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
Active Ingredients
PRALIDOXIME CHLORIDE

Indications and Usage

INDICATIONS AND USAGE 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.

Warnings

WARNINGS PROTOPAM Chloride is not effective in the treatment of poisoning due to phosphorus, inorganic phosphates, or organophosphates not having anticholinesterase activity. PROTOPAM Chloride is not indicated as an antidote for intoxication by pesticides of the carbamate class since it may increase the toxicity of carbaryl.