Pralidoxime Chloride label

Pralidoxime Chloride

Pralidoxime Chloride Recall

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Side Effects & Adverse Reactions

Pralidoxime is not effective in the treatment of poisoning due to phosphorus, inorganic phosphates or organophosphates not having anticholinesterase activity.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

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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History

There is currently no drug history available for this drug.

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Other Information

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.

Structural Formula:

Image from Drug Label Content

Pralidoxime chloride occurs as an odorless, white, nonhygroscopic, crystalline powder which is soluble in water to the extent of 1 g in less than 1 mL.  Stable in air, it melts between 215°C and 225°C, with decomposition.

The specific activity of the drug resides in the 2-formyl-1 methylpyridinium ion and is independent of the particular salt employed. The chloride is preferred because of physiologic compatibility, excellent water solubility at all temperatures, and high potency per gram, due to its low (173) molecular weight.

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Pralidoxime Chloride Manufacturers

  • Meridian Medical Technologies, Inc.
    Pralidoxime Chloride | Meridian Medical Technologies, Inc.
    No Recall

    Pralidoxime Chloride | Meridian Medical Technologies, Inc.

    Pralidoxime Chloride | Meridian Medical Technologies, Inc.

    Exposure to nerve agents possessing anticholinesterase activity (organophosphate type)

    MILD CASE—headache, blurred vision, mild muscarinic signs

    MODERATELY SEVERE CASE—excessive sweating, lacrimation, salivation, diarrhea, tightness in the chest

    For optimal reactivation of organophosphate-inhibited cholinesterase, atropine and pralidoxime should be administered as soon as possible after exposure. Depending on the severity of symptoms, immediately administer one atropine-containing auto-injector, followed by one pralidoxime-containing auto-injector. Atropine must be given first until its effects become apparent and only then should pralidoxime be administered. If nerve agent symptoms are still present after 15 minutes, repeat injections. If symptoms still exist after an additional 15 minutes, repeat injections for a third time. If after the third set of injections, symptoms remain, do not give any more antidotes but seek medical help.

    Directions for Use:

    When, as described above, auto-injector use is indicated, proceed as follows:

    Remove gray safety cap. Place black end against outer thigh and push hard until the injector functions. Hold firmly in place for ten seconds, then remove. Massage the area of injection. Dispose of properly. Push ejected needle through a pocket flap (or other thick and conspicuous part of outer clothing). Bend needle into a hook.

    VERY SEVERE CASE — Cyanosis, Respiratory Embarrassment, Coma

    Initial measures should include removal of secretions, maintenance of a patent airway and, if necessary, artificial ventilation. Atropine should not be used until cyanosis has been overcome since atropine produces ventricular fibrillations in the presence of hypoxia. Morphine, theophylline, aminophylline, or succincylcholine are contraindicated. Tranquilizers of the reserpine or phenothiazine type are to be avoided.

    "Pralidoxime is most effective if administered immediately after poisoning. Generally, little is accomplished if the drug is given more than 36 hours after termination of exposure. When the poison has been ingested, however, exposure may continue for some time due to slow absorption from the lower bowel, and fatal relapses have been reported after initial improvement. Continued administration for several days may be useful in such patients. Close supervision of the patient is indicated for at least 48 to 72 hours. If dermal exposure has occurred, clothing should be removed and the hair and skin washed thoroughly with sodium bicarbonate or alcohol as soon as possible. Diazepam may be given cautiously if convulsions are not controlled by atropine."7

    IMPORTANT: PHYSICIANS AND/OR OTHER MEDICAL PERSONNEL ASSISTING EVACUATED VICTIMS OF NERVE AGENTS, SHOULD AVOID EXPOSING THEMSELVES TO CONTAMINATION BY THE VICTIMS' CLOTHING.

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