Pralidoxime

Indications

INDICATIONS AND USAGE PROTOPAM Chloride is indicated as an antidote: in the treatment of poisoning due to those pesticides and chemicals (e.g., nerve agents) of the organophosphate class which have anticholinesterase activity and 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.

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION Organophosphate Poisoning Treatment should include general supportive care, atropinization, and decontamination, in addition to the use of PROTOPAM Chloride. Treatment is most effective if initiated immediately after poisoning. Administration of PROTOPAM Chloride should be carried out slowly and, preferably, by infusion. If intravenous administration is not feasible, intramuscular or subcutaneous injection should be used. Generally, little is accomplished if PROTOPAM Chloride is given more than 36 hours after termination of exposure to the poison.

Contraindications

CONTRAINDICATIONS There are no known absolute contraindications for the use of PROTOPAM Chloride (see PRECAUTIONS, Drug Interactions and DOSAGE AND ADMINISTRATION ). Relative contraindications include known hypersensitivity to the drug and other situations in which the risk of its use clearly outweighs possible benefit.

Warnings and precautions

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.

Pregnancy

Pregnancy Teratogenic Effects: Animal reproduction studies have not been conducted with pralidoxime chloride. It is also not known whether pralidoxime chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Pralidoxime chloride should be given to a pregnant woman only if clearly needed.

Storage and supply

Storage Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) .

Source: Pralidoxime Chloride (Protopam Chloride) — US FDA prescribing information, 2026-04-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.