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Pralidoxime Injection (Pralidoxime Chloride Injection) - Summary




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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Published Studies Related to Pralidoxime Injection

Pharmacokinetic analysis of pralidoxime after its intramuscular injection alone or in combination with atropine-avizafone in healthy volunteers. [2010.12]
BACKGROUND AND PURPOSE: Treatment of organophosphate poisoning with pralidoxime needs to be improved. Here we have studied the pharmacokinetics of pralidoxime after its intramuscular injection alone or in combination with avizafone and atropine using an auto-injector device... CONCLUSIONS AND IMPLICATIONS: The two approaches, non-compartmental and compartmental, showed that the administration of avizafone and atropine with pralidoxime results in a faster absorption into the general circulation and higher maximal concentrations, compared with the administration of pralidoxime alone.

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.

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Clinical Trials Related to Pralidoxime Injection

Is the WHO Recommended Dose of Pralidoxime Effective in the Treatment of Organophosphorus Poisoning? [Completed]

Adding Nebulized Salbutamol to Intravenous Atropine and Oxygen in OP Poisoning [Recruiting]
We hypothesize that salbutamol will speed removal of alveolar fluid compared to atropine alone in OP poisoned patients. We propose to compare the effect of two stat doses of nebulized salbutamol (2. 5 mg; 5. 0 mg), with nebulized saline placebo, in symptomatic patients receiving standard resuscitation with atropine, oxygen, and fluids after poisoning with OP pesticides. 25 patients will be randomised to each arm (total 75 patients). Primary outcome will be oxygen saturation's over the following 60 min during resuscitation. Secondary outcomes will include atropine dose administered, speed to stabilization, aspiration or pneumonia, intubation, tachydysrhythmias, and mortality. A positive outcome will result in design of a large definitive phase III study.

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Page last updated: 2011-12-09

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