DuoDote® Auto-Injector

(atropine and pralidoxime chloride injection)

Dosing

DuoDote® is indicated for the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides. It should be administered by emergency medical services personnel who have had adequate training in the recognition and treatment of organophosphorous nerve agent or insecticide intoxication.1

Each DuoDote® Auto-Injector dose contains 2.1 mg of atropine in 0.7 mL of sterile, pyrogen-free solution and 600 mg of pralidoxime chloride in 2 mL of sterile, pyrogen-free solution.

More in-depth dosing and administration instruction has been provided in a downloadable training presentation for registered users.

DuoDote® is indicated for the treatment of poisoning by organophosphorous nerve agents as well as organophosphorus insecticides. It should be administered by emergency medical services personnel who have had adequate training in the recognition and treatment of organophosphorous nerve agent or insecticide intoxication.1

Each DuoDote® Auto-Injector dose contains 2.1 mg of atropine in 0.7 mL of sterile, pyrogen-free solution and 600 mg of pralidoxime chloride in 2 mL of sterile, pyrogen-free solution.

More in-depth dosing and administration instruction has been provided in a downloadable training presentation for registered users.

Mild Symptoms1

Administer 1 DuoDote® injection into the mid-lateral thigh if the patient experiences 2 or more MILD symptoms of organophosphorous nerve agent or insecticide poisoning.

Evacuation and decontamination procedures should be undertaken as soon as possible to remove yourself and others from the contaminated area. If, after 10 to 15 minutes, the patient does not develop any SEVERE symptoms, no additional DuoDote® injections are recommended, but definitive medical care should be sought immediately.

  • Emergency medical services personnel experiencing mild symptoms may self-administer a single dose of DuoDote®
  • 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

Worsening Symptoms1

If at any time after the first dose the patient develops any additional symptoms, or if symptoms worsen, administer 2 more DuoDote® injections in rapid succession and immediately seek definitive medical care. 

Important Notes

  • Severe difficulty in breathing after organophosphorous poisoning requires artificial respiration in addition to the use of DuoDote®
  • A potential hazardous effect of atropine is inhibition of sweating, which, in a warm environment or with exercise, can lead to hyperthermia and heat injury

Severe Symptoms Upon Initial Presentation1

If a patient experiences any SEVERE symptoms, immediately administer 3 DuoDote® injections into the patient's mid-lateral thigh in rapid succession, and immediately seek definitive medical care.

No more than 3 doses of DuoDote® should be administered unless definitive medical care (eg, hospitalization, respiratory support) is available.1

  • 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*12
  • 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
     
* Diazepam is recommended in addition to DuoDote® if symptoms include convulsions.1 Please see Important Safety Information and full Prescribing Information for diazepam.
Indication

DuoDote® (atropine and pralidoxime chloride injection) Auto-Injector is indicated for the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides.

Important Safety Information

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. It is intended as an initial treatment of the symptoms of organophosphorous nerve agent or insecticide poisoning; definitive medical care should be sought immediately.

Individuals should not rely solely upon agents such as atropine and pralidoxime to provide complete protection from organophosphorous nerve agents and insecticide poisoning. Primary protection against exposure to organophosphorous nerve agents and insecticides 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 organophosphorous nerve agent or insecticide poisoning should avoid contaminating themselves by exposure to the victim's clothing.

In the presence of life-threatening poisoning by organophosphorous nerve agents or insecticides there are no absolute contraindications to the use of DuoDote®. When symptoms of poisoning are not severe, DuoDote® should be used with extreme caution in people with heart disease, arrhythmias, recent myocardial infarction, severe narrow angle glaucoma, pyloric stenosis, prostatic hypertrophy, significant renal insufficiency, chronic pulmonary disease, or hypersensitivity to any compound of the product.

No more than three doses should be administered unless definitive medical care (eg, hospitalization, respiratory support) is available. Elderly people and children may be more susceptible to the effects of atropine. DuoDote® is pregnancy Category C and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Safety and effectiveness in children have not been established.

Muscle tightness and sometimes pain may occur at the injection site. The most common adverse effects of atropine can be attributed to its antimuscarinic action and include dryness of mouth, blurred vision, dry eyes, photophobia, confusion, headache, and dizziness among others. Pralidoxime chloride's adverse effects include changes in vision, dizziness, headache, drowsiness, nausea, tachycardia, increased blood pressure, muscular weakness, dry mouth, emesis, rash, dry skin, hyperventilation, decreased renal function, excitement, manic behavior, and transient elevation of liver enzymes and creatine phosphokinase. When atropine and pralidoxime are used together, the signs of atropinization may occur earlier than might be expected when atropine is used alone.


Indication for Diazepam

Diazepam injection is indicated as an adjunct in status epilepticus and severe recurrent convulsive seizures.

Diazepam autoinjector has other indications that are listed in the full Prescribing Information.

Important Safety Information

Intravenous administration of diazepam with the auto-injector is contraindicated.

Diazepam injection is contraindicated in patients with a known hypersensitivity to this drug; acute narrow angle glaucoma; and open angle glaucoma unless patients are receiving appropriate therapy.

Diazepam auto-injector is to be administered only by the intramuscular (IM) route.

Extreme care must be used in administering injectable diazepam to the elderly, to very ill patients and to those with limited pulmonary reserve. Concomitant use of barbiturates, alcohol, or other central nervous system depressants increases depression with increased risk of apnea. Resuscitative equipment including that necessary to support respiration should be readily available.

Diazepam injection should not be administered to patients in shock, coma, or in acute alcoholic intoxication with depression of vital signs.

Patients receiving diazepam should be cautioned against engaging in hazardous occupations requiring complete mental alertness, such as operating machinery or driving a motor vehicle.

The use of diazepam during the first trimester of pregnancy should almost always be avoided. Diazepam injection is not recommended for obstetrical use.

The cumulative maximum dose of diazepam should not exceed 30 mg; the interval between doses should be no less than 10 minutes.

Side effects most commonly reported with diazepam injection are drowsiness, fatigue and ataxia, venous thrombosis, and phlebitis at the site of injection. Manifestations of diazepam overdosage include somnolence, confusion, coma and diminished reflexes.

Withdrawal symptoms have occurred following the abrupt discontinuation of diazepam.

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The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

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BinaJect and DuoDote are registered trademarks of Meridian Medical Technologies™, Inc., a Pfizer company.
Copyright © 2012 Meridian Medical Technologies™, Inc., a Pfizer company. All rights reserved. DUO464708-01 Nov 2012