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DuoDote

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DuoDote

INDICATIONS

DuoDote is indicated for the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides.

The DuoDote Auto-Injector should be administered by emergency medical services personnel who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication.

The DuoDote Auto-Injector is intended as an initial treatment of the symptoms of organophosphorous insecticide or nerve agent poisonings; definitive medical care should be sought immediately.

The DuoDote Auto-Injector should be administered as soon as symptoms of organophosphorous poisoning appear (e.g., usually tearing, excessive oral secretions, sneezing, muscle fasciculations). (See DOSAGE AND ADMINISTRATION)

INDIVIDUALS SHOULD NOT RELY SOLELY UPON ATROPINE AND PRALIDOXIME TO PROVIDE COMPLETE PROTECTION FROM CHEMICAL NERVE AGENTS AND INSECTICIDE POISONING.

PRIMARY PROTECTION AGAINST EXPOSURE TO CHEMICAL NERVE AGENTS AND INSECTICIDE POISONING IS THE WEARING OF PROTECTIVE GARMENTS INCLUDING MASKS DESIGNED SPECIFICALLY FOR THIS USE.

EVACUATION AND DECONTAMINATION PROCEDURES SHOULD BE UNDERTAKEN AS SOON AS POSSIBLE. MEDICAL PERSONNEL ASSISTING EVACUATED VICTIMS OF NERVE AGENT POISONING SHOULD AVOID CONTAMINATING THEMSELVES BY EXPOSURE TO THE VICTIM'S CLOTHING.

DOSAGE AND ADMINISTRATION

THE DUODOTE AUTO-INJECTOR SHOULD BE ADMINISTERED BY EMERGENCY MEDICAL SERVICES PERSONNEL WHO HAVE HAD ADEQUATE TRAINING IN THE RECOGNITION AND TREATMENT OF NERVE AGENT OR INSECTICIDE INTOXICATION.

CAUTION! INDIVIDUALS SHOULD NOT RELY SOLELY UPON ATROPINE AND PRALIDOXIME TO PROVIDE COMPLETE PROTECTION FROM CHEMICAL NERVE AGENTS AND INSECTICIDE POISONING.

PRIMARY PROTECTION AGAINST EXPOSURE TO CHEMICAL NERVE AGENTS AND INSECTICIDE POISONING IS THE WEARING OF PROTECTIVE GARMENTS INCLUDING MASKS DESIGNED SPECIFICALLY FOR THIS USE.

EVACUATION AND DECONTAMINATION PROCEDURES SHOULD BE UNDERTAKEN AS SOON AS POSSIBLE. MEDICAL PERSONNEL ASSISTING EVACUATED VICTIMS OF NERVE AGENT POISONING SHOULD AVOID CONTAMINATING THEMSELVES BY EXPOSURE TO THE VICTIM'S CLOTHING.

DuoDote is indicated for the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides. DuoDote should only be administered to patients experiencing symptoms of organophosphorous poisoning in a situation where exposure is known or suspected. DuoDote should be administered as soon as symptoms of organophosphorous poisoning appear.

The DuoDote Auto-Injector is intended as an initial treatment of the symptoms of organophosphorous insecticide or nerve agent poisonings; definitive medical care should be sought immediately.

Nerve Agent And Insecticide Poisoning Symptoms

Common symptoms of organophosphorous exposure are listed below. Individuals may not have all symptoms:

Mild Symptoms
  • Blurred vision, miosis
  • Excessive, unexplained teary eyes
  • Excessive, unexplained runny nose
  • Increased salivation such as sudden drooling
  • Chest tightness or difficulty breathing
  • Tremors throughout the body or muscular twitching
  • Nausea and/or vomiting
  • Unexplained wheezing, coughing or increased airway secretions
  • Acute onset of stomach cramps
  • Tachycardia or bradycardia
Severe Symptoms
  • Strange or confused behavior
  • Severe difficulty breathing or copious secretions from lungs/airway
  • Severe muscular twitching and general weakness
  • Involuntary urination and defecation
  • Convulsions
  • Unconsciousness

Three (3) DuoDote Auto-Injectors should be available for use in each patient (including emergency medical services personnel) at risk for organophosphorous poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms as described below. Each DuoDote Auto-Injector delivers atropine 2.1 mg plus pralidoxime chloride 600 mg.

Treatment Of Mild Symptoms

First Dose: In the situation of known or suspected organophosphorous poisoning, administer one (1) DuoDote injection into the mid-lateral thigh if the patient experiences two or more MILD symptoms of nerve gas or insecticide exposure.

Emergency medical services personnel with mild symptoms may self-administer a single dose of DuoDote.

Wait 10 to 15 minutes for DuoDote to take effect. If, after 10 to 15 minutes, the patient does not develop any of the SEVERE symptoms listed above, no additional DuoDote injections are recommended, but definitive medical care should ordinarily be sought immediately. For emergency medical services personnel who have self-administered DuoDote, an individual decision will need to be made to determine their capacity to continue to provide emergency care.

Additional Doses: If, at any time after the first dose, the patient develops any of the SEVERE symptoms listed above, administer two (2) additional DuoDote injections in rapid succession, and immediately seek definitive medical care.

Treatment Of Severe Symptoms

If a patient has any of the SEVERE symptoms listed above, immediately administer three (3) DuoDote injections into the patient's mid-lateral thigh in rapid succession, and immediately seek definitive medical care.

No more than three doses of DuoDote should be administered unless definitive medical care (e.g., hospitalization, respiratory support) is available.

Emergency care of the severely poisoned individual should include removal of oral and bronchial secretions, maintenance of a patent airway, supplemental oxygen, and, if necessary, artificial ventilation.

An anticonvulsant such as diazepam may be administered to treat convulsions if suspected in the unconscious individual. The effects of nerve agents and some insecticides can mask the motor signs of a seizure.

Close supervision of all severely poisoned patients is indicated for at least 48 to 72 hours.

Instructions For The Use Of The Duodote Auto-Injector

(Also see the illustrated Instruction Sheet for Emergency Medical Personnel)

IMPORTANT: Do Not Remove Gray Safety Release until ready to use.

CAUTION: Never touch the Green Tip (Needle End)!

  1. Tear open the plastic pouch at any of the notches. Remove the DuoDote Auto-Injector from the pouch.
  2. Place the DuoDote Auto-Injector in your dominant hand. (If you are right-handed, your right hand is dominant.) Firmly grasp the center of the DuoDote Auto- Injector with the Green Tip (needle end) pointing down.
  3. With your other hand, pull off the Gray Safety Release. The DuoDote Auto-Injector is now ready to be administered.
  4. The injection site is the mid-outer thigh area. The DuoDote Auto-Injector can inject through clothing. However, make sure pockets at the injection site are empty.
  5. Swing and firmly push the Green Tip straight down (a 90° angle) against the mid-outer thigh. Continue to firmly push until you feel the DuoDote Auto-Injector trigger.
    IMPORTANT: After the auto-injector triggers, hold the DuoDote Auto-Injector firmly in place against the injection site for approximately 10 seconds.
  6. Remove the DuoDote Auto-Injector from the thigh and look at the Green Tip. If the needle is visible, the drug has been administered. If the needle is not visible, check to be sure the Gray Safety Release has been removed, and then repeat above steps beginning with Step 4, but push harder in Step 5.
  7. After the drug has been administered, push the needle against a hard surface to bend the needle back against the DuoDote Auto-Injector.
  8. Put the used DuoDote Auto-Injector back into the plastic pouch, if available. Leave used DuoDote Auto-Injector(s) with the patient to allow other medical personnel to see the number of DuoDote Auto-Injector(s) administered.
  9. Immediately move yourself and the patient away from the contaminated area and seek definitive medical care for the patient.

HOW SUPPLIED

Each DuoDote Auto-Injector contains a sterile solution of atropine (2.1 mg/0.7 mL) and a sterile solution of pralidoxime chloride (600 mg/2 mL) in two separate internal chambers. When activated, the DuoDote Auto-Injector sequentially administers both drugs intramuscularly through a single needle in one injection.

DuoDote is available in a single unit carton, NDC-11704-620-01.

Each DuoDote is supplied in a pouch that provides protection from light.

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [See USP Controlled Room Temperature]. Contains no latex. Keep from freezing. Protect from light.

Manufactured by: Meridian Medical Technologies™, Inc., Columbia, MD 21046.

Last reviewed on RxList: 4/25/2013
This monograph has been modified to include the generic and brand name in many instances.

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