Defense Against an Uncertain World

We believe emergency medical personnel, the armed forces, and firefighters are our Real World Heroes. Their job is ultimately to protect the lives of others, themselves, and their loved ones. At Meridian, we are dedicated to doing our part to help by providing quality products and advancing the technology of drug delivery devices.

Antidote Treatment Nerve Agent, Auto-Injector (ATNAA) (atropine and pralidoxime chloride injection)

Indication: For the treatment of poisoning by susceptible organophosphorous nerve agents having anticholinesterase activity.

This product is only available for use by United States military personnel.

Important Safety Information

The ATNAA Auto-Injector should be administered by military personnel who have had adequate training in the recognition and treatment of nerve agent intoxication. It is intended as an initial treatment of the symptoms of organophosphorous nerve agent poisoning; additional medical care should be sought as soon as possible.

Individuals should not rely solely upon agents such as atropine and pralidoxime when encountering a situation of nerve agent exposure. Primary protection against exposure to organophosphorous nerve agents 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 poisoning should avoid contaminating themselves by exposure to the victim's clothing.

In the presence of life-threatening poisoning by organophosphorous nerve agents there are no absolute contraindications to the use of ATNAA. When symptoms of poisoning are not severe, ATNAA 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.

Severe difficulty in breathing requires artificial respiration in addition to the use of the ATNAA.

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

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. ATNAA 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 full Prescribing Information for ATNAA (PDF).

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CYANOKIT® (hydroxocobalamin for injection) 5 g

Indication: CYANOKIT (hydroxocobalamin for injection) 5 g for intravenous infusion is indicated for the treatment of known or suspected cyanide poisoning. If clinical suspicion of cyanide poisoning is high, CYANOKIT should be administered without delay.

Important Safety Information

Cyanide poisoning may result from inhalation, ingestion, or dermal exposure. Prior to administration of CYANOKIT, smoke-inhalation victims should be assessed for: exposure to fire or smoke in an enclosed area; presence of soot around the mouth, nose, or oropharynx; and altered mental status. In addition to CYANOKIT, treatment of cyanide poisoning must include immediate attention to airway patency, adequacy of oxygenation and hydration, cardiovascular support, and management of any seizure activity.

Use caution in the management of patients with known anaphylactic reactions to hydroxocobalamin or cyanocobalamin. Consideration should be given to use of alternative therapies, if available. Allergic reactions may include: anaphylaxis, chest tightness, edema, urticaria, pruritus, dyspnea, and rash. Allergic reactions including angioneurotic edema have also been reported in postmarketing experience.

Substantial increases in blood pressure may occur following CYANOKIT therapy. Elevations in blood pressure (≥180 mmHg systolic or ≥110 mmHg diastolic) were observed in approximately 18% of healthy subjects receiving hydroxocobalamin 5 g and 28% of subjects receiving 10 g. 

Usage may interfere with some clinical laboratory evaluations. Also, because of its deep red color, hydroxocobalamin may cause hemodialysis machines to shut down due to an erroneous detection of a "blood leak." This should be considered before hemodialysis is initiated in patients treated with hydroxocobalamin. Due to potential photosensitivity, patients should avoid direct sun until erythema resolves. 

CYANOKIT is Pregnancy Category C and should be used during pregnancy only if the potential benefit justifies the potential risk. Safety and effectiveness of CYANOKIT have not been established in pediatric patients.

The most common adverse reactions (>5%) included transient chromaturia, erythema, rash (predominantly acneiform), increased blood pressure, nausea, headache, decreased lymphocyte percentage, and injection site reactions.

View full Prescribing Information for CYANOKIT (PDF).

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DuoDote® Auto-Injector (atropine and pralidoxime chloride injection)

Indication: DuoDote Auto-Injector (atropine and pralidoxime chloride injection) 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 full Prescribing Information for DuoDote (PDF).

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