Antidote Treatment Nerve Agent, Auto-Injector (ATNAA) (atropine and pralidoxime chloride injection)
Indication: For the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides.
This product is only FDA approved for United States military personnel.
Important Safety Information
The ATNAA 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 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.
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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AtroPen® Auto-Injector (atropine injection)
Indication: The AtroPen® Auto-Injector is indicated for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides.
The AtroPen® Auto-Injector should be used by persons who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication. The AtroPen® is intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings (generally breathing difficulties due to increased secretions); definitive medical care should be sought immediately.
Important Safety Information
In the face of life-threatening poisoning by organophosphorous nerve agents and insecticides, there are no absolute contraindications for the use of atropine.
Primary protection against exposure to chemical nerve agents and insecticide poisoning is the wearing of protective garments including masks designed specifically for this use. Individuals should not rely solely upon antidotes such as atropine and pralidoxime to provide complete protection from chemical nerve agents and insecticide poisoning. Immediate evacuation from the contaminated environment is essential. Decontamination of the poisoned individual should occur as soon as possible.
AtroPen® should be administered with extreme caution to individuals with the following disorders when the symptoms of nerve agent poisoning are less severe: individuals who are hypersensitive to any component of the product, disorders of heart rhythm such as atrial flutter, severe narrow angle glaucoma, pyloric stenosis, prostatic hypertrophy, significant renal insufficiency, or a recent myocardial infarction.
No more than three doses should be administered unless under the supervision of trained medical personnel. Children and the elderly may be more susceptible to the pharmacologic effects of atropine.
Severe difficulty in breathing requires artificial respiration in addition to the use of atropine since atropine is not dependable in reversing the weakness or paralysis of the respiratory muscles.
Pregnancy Category C. Atropine should be administered to a pregnant woman only if clearly needed.
Mild to moderate pain may be experienced at the site of injection. The major and most common side effects of atropine can be attributed to its antimuscarinic action and include dryness of the mouth, blurred vision, photophobia, confusion, headache, dizziness, and anhidrosis among others.
View full Prescribing Information for AtroPen® (PDF).
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CYANOKIT® (hydroxocobalamin for injection) 5 g
Indication: 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. Allergic reactions may include: anaphylaxis, chest tightness, edema, urticaria, pruritus, dyspnea, rash, and angioneurotic edema.
Substantial increases in blood pressure may occur following CYANOKIT® therapy. 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%) are transient and include chromaturia, erythema, rash (predominantly acneiform), increased blood pressure, nausea, headache, decreased lymphocyte percentage, and injection site reactions.
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Diazepam Auto-Injector C-IV (diazepam injection)
Indications: Diazepam is indicated for the management of anxiety disorders for the short-term relief of the symptoms of anxiety, excluding mild and moderate degrees of anxiety and anxiety related disorders.
In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis.
As an adjunct prior to endoscopic procedures if apprehension, anxiety or acute stress reactions are present, and to diminish the patient's recall of the procedures.
Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology, spasticity caused by upper motor neuron disorders, athetosis, stiff man syndrome, and tetanus.
Diazepam injection is a useful adjunct in status epilepticus and severe recurrent convulsive seizures.
Diazepam is useful premedication for relief of anxiety and tension in patients who are to undergo surgical procedures.
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.
View full Prescribing Information for Diazepam (PDF).
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DuoDote® Auto-Injector (atropine and pralidoxime chloride injection)
Indication: For the treatment of poisoning by organophosphorous nerve agents as well as organophosphorous insecticides.
Important Safety Information
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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Morphine Auto-Injector C-II (morphine sulfate injection)
Indication: For intramuscular injection for the management of pain.
Important Safety Information
Morphine sulfate may be habit forming.
This product is contraindicated in patients with a known hypersensitivity to morphine.
The morphine auto-injector system was developed for use under conditions which require an automatic injection device. It carries a low risk of inadvertent intravascular injection and injection site reactions. It is preferable to deliver morphine by standard hospital techniques when conditions permit.
Morphine should be used with caution in patients with increased intracranial pressure or with head injury. Care is urged in using this drug in patients who have a decreased respiratory reserve and some other respiratory conditions such as asthma. The administration of morphine may result in severe hypotension in an individual whose ability to maintain their blood pressure has been compromised by blood loss or shock. Therapeutic administration of morphine may result in smooth muscle hyper tonicity which can aggravate or induce biliary colic. Caution must be used when injecting any opioid intramuscularly into chilled areas or in patients with hypotension or shock.
Analgesic doses of morphine cloud judgment and impair the mental and/or physical abilities which are required for the performance of tasks such as driving a vehicle or operating machinery. Morphine should be administered cautiously to avoid additive effects when other central nervous system depressants including other narcotic analgesics, general anesthetics and alcohol are given concomitantly. Use of morphine in conjunction with other CNS active drugs may increase the risk of respiratory depression.
Morphine is a Pregnancy Category C medication. As the auto-injector is intended for fixed-dose administration by non-medical personnel, it is not recommended for routine obstetrical analgesia. Use of this product in nursing mothers should be guided by the relative risk of narcotic effects in the infant and the maternal need for analgesia.
This product is not designed for use in pediatric patients under the age of 14 or weighing less than 40 kg (90 lb). The pharmacodynamic effects of morphine in the aged are more variable than in the younger population.
Adverse reactions: The major hazards of morphine are respiratory depression, and to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest, particularly with overdosage, rapid intravenous administration, and pre-existing hypovolemic shock. The most frequently observed adverse reactions include sedation, lightheadedness, dizziness, nausea, vomiting, and sweating.
The morphine sulfate in the auto-injector is an opioid agonist and a schedule II controlled substance with an abuse liability similar to other legal or illegal opioid agonists. Overdosage of morphine is characterized by respiratory depression, with or without concomitant CNS depression.
The morphine Auto-Injector contains a spring-driven injection mechanism and is capable of inflicting injury if accidentally misused.
Caution: Federal Law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.
View full Prescribing Information for Morphine (PDF).
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Pralidoxime Chloride Auto-Injector (pralidoxime chloride injection)
Indication: This auto-injector for pralidoxime chloride is specifically indicated for intramuscular use as an adjunct to atropine in the treatment of poisoning by nerve agents having anticholinesterase activity.
Important Safety Information
The pralidoxime chloride auto-injector is contraindicated in patients who are hypersensitive to any component of the product.
Pralidoxime is not effective in the treatment of poisoning due to phosphorus, inorganic phosphates or organophosphates not having anticholinesterase activity.
Because pralidoxime is excreted in the urine, a decrease in renal function will result in increased blood levels of the drug. Thus the dosage of pralidoxime should be reduced in the presence of renal insufficiency.
The pralidoxime chloride auto-injector should be self- or buddy- administered by military personnel or administered by qualified civilian emergency medical personnel only after the individual has donned his mask and ensured that some or all of the symptoms of nerve agent poisoning are present.
Pregnancy Category C. Pralidoxime should be administered to a pregnant woman only if clearly needed.
Mild to moderate pain may be experienced at the site of injection. Pralidoxime may cause blurred vision, diplopia and impaired accommodation, dizziness, headache, and drowsiness among other symptoms.
View full Prescribing Information for Pralidoxime Chloride (PDF).
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