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.
View the full Prescribing Information for DuoDote®.
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.
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.
This Web site is intended only for first responders and healthcare professionals and is subject to all applicable US laws. The product information provided in this site is intended only for residents of the United States. The products discussed herein may have different product labeling in different countries.
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