SUMMARY
PRALIDOXIME CHLORIDE INJECTION
(AUTO-INJECTOR)
Pralidoxime Chloride Injection (auto-injector) provides pralidoxime chloride in a sterile solution for intramuscular injection. Each prefilled auto-injector provides a dose of the antidote, pralidoxime chloride in a self-contained unit, specially designed for automatic self- or buddy- administration by military personnel. Pralidoxime in the auto-injector may also be administered by qualified civilian emergency responders who have had adequate training in the on-site recognition and treatment of nerve agent intoxication in the event of an accidental release of nerve agent. The recommended procedure (see DOSAGE AND ADMINISTRATION) is to inject the contents of the auto-injector into the muscles of an outer thigh. After an auto-injector has been activated, the empty container should be disposed of properly (see DOSAGE AND ADMINISTRATION), it cannot be refilled nor can the protruding needle be retracted. When activated, each auto-injector dispenses 600 mg of pralidoxime chloride in 2 mL of a sterile solution containing 20 mg/mL benzyl alcohol, 11.26 mg/mL glycine in Water for Injection, USP. The pH is adjusted with hydrochloric acid. The pH range is 2.0-3.0. The product is pyrogen free. Pralidoxime chloride is a cholinesterase reactivator. Chemical Name: 2-formyl-1 methylpyridinium chloride oxime (pyridine-2-aldoxime methochloride). Also referred to as 2-PAM Chloride.
This auto-injector for pralidoxime chloride is specifically indicated for intramuscular use as an adjunct to atropine in the treatment of poisoning by nerve agents having anticholinesterase activity.
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NEWS HIGHLIGHTS
Published Studies Related to Pralidoxime Injection
Continuous pralidoxime infusion versus repeated bolus injection to treat organophosphorus pesticide poisoning: a randomised controlled trial. [2006.12.16]
BACKGROUND: The role of oximes for the treatment of organophosphorus pesticide poisoning has not been conclusively established. We aimed to assess the effectiveness of a constant pralidoxime infusion compared with repeated bolus doses to treat patients with moderately severe poisoning from organophosphorus pesticides... INTERPRETATION: A high-dose regimen of pralidoxime, consisting of a constant infusion of 1 g/h for 48 h after a 2 g loading dose, reduces morbidity and mortality in moderately severe cases of acute organophosphorus-pesticide poisoning.
Clinical Trials Related to Pralidoxime Injection
Study to Know the Efficacy of Higher Doses of Pralidoxime in Patients of Organophpsphorus Poisoning. [Completed]
The purpose of this study is to determine whether high doses of pralidoxime(PAM) are
effective as compare to lower doses of PAM in the management of moderately sever
organophosphorus poisoning patients.
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