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Basic Drug Info
Drug Name:DuoDote
Manufacturer:Meridian Medical Technologies, Inc.
Other Info:

(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)!Tear open the plastic pouch at any of the notches.

Remove the DuoDote Auto-Injector from the pouch.Place the DuoDote Auto-Injector in your dominant hand.

(If you are right-handed, your right hand is dominant.) Firmly graspthe center of the DuoDote Auto-lnjector with the Green Tip (needle end) pointing down.With your other hand, pull off the Gray Safety Release.

The DuoDote Auto-lnjector is now ready to be administered.The injection site is the mid-outer thigh area.

The DuoDote Auto-lnjector can inject through clothing.

However, make sure pockets at the injection site are empty.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-lnjector trigger.

IMPORTANT: After the auto-injector triggers, hold the DuoDote Auto-lnjector firmly in place against the injection site for approximately 10 seconds.Remove the DuoDote Auto-lnjector 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.After the drug has been administered, push the needle against a hard surface to bend the needle back against the DuoDote Auto-lnjector.Put the used DuoDote Auto-lnjector back into the plastic pouch, if available.

Leave used DuoDote Auto-lnjector(s) with the patient to allow other medical personnel to see the number of DuoDote Auto-lnjector(s) administered.Immediately move yourself and the patient away from the contaminated area and seek definitive medical care for the patient.



Clinical Trials:


Indications and Usage

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.
Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.

Excessive tearing --

Sneezing -- The sudden, forceful, involuntary expulsion of air from the NOSE and MOUTH caused by irritation to the MUCOUS MEMBRANES of the upper RESPIRATORY TRACT.

Muscular fasciculation -- Involuntary contraction of the muscle fibers innervated by a motor unit. Fasciculations can often by visualized and take the form of a muscle twitch or dimpling under the skin, but usually do not generate sufficient force to move a limb. They may represent a benign condition or occur as a manifestation of MOTOR NEURON DISEASE or PERIPHERAL NERVOUS SYSTEM DISEASES. (Adams et al., Principles of Neurology, 6th ed, p1294)

Contraindications
In the presence of life-threatening poisoning by organophosphorous nerve agents or insecticides, there are no absolute contraindications to the use of DuoDote.
Warnings

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.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 component of the product.

Organophosphorous nerve agent poisoning often causes bradycardia but can be associated with a heart rate in the low, high, or normal range.

Atropine increases heart rate and alleviates the bradycardia.

In patients with a recent myocardial infarction and/or severe coronary artery disease, there is a possibility that atropine-induced tachycardia may cause ischemia, extend or initiate myocardial infarcts, and stimulate ventricular ectopy and fibrillation.

In patients without cardiac disease, atropine administration is associated with the rare occurrence of ventricular ectopy or ventricular tachycardia.

Conventional systemic doses may precipitate acute glaucoma in susceptible individuals, convert partial pyloric stenosis into complete pyloric obstruction, precipitate urinary retention in individuals with prostatic hypertrophy, or cause inspiration of bronchial secretions and formation of dangerous viscid plugs in individuals with chronic lung disease.More than one dose of DuoDote, to a maximum of three doses, may be necessary initially when symptoms are severe.

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

(See DOSAGE AND ADMINISTRATION)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.The elderly and children may be more susceptible to the effects of atropine.

This web-site is for informational purposes only and is not intended as a substitute for advice from your doctor. It should not to be used for self-diagnosis or treatment.