AtroPen® Auto-Injector (atropine injection)

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.

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.

CYANOKIT (hydroxocobalamin for injection) 5 g

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.

Acute renal failure with acute tubular necrosis, renal impairment, and urine calcium oxalate crystals have been reported following CYANOKIT therapy. Monitor renal function for 7 days following CYANOKIT therapy.

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.

There are no adequate and well-controlled studies of CYANOKIT in pregnant women. CYANOKIT should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Safety and effectiveness of CYANOKIT have not been established in pediatric patients.

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

DuoDote® Auto-Injector (atropine and pralidoxime chloride injection), for intramuscular use

There are no contraindications to the use of DuoDote.

Cardiovascular Risks include tachycardia, palpitations, premature ventricular contractions, flutter, fibrillation, asystole, myocardial infarction and other cardiovascular adverse reactions have been reported in the literature. Use caution in patients with known CV disease or conduction problems.

Heat injury may occur. May inhibit sweating and lead to hyperthermia; avoid excessive exercising and heat exposure.

Acute glaucoma may be precipitated in susceptible individuals and therefore DuoDote should be administered with caution in patients at risk for acute glaucoma.

Administer with caution in patient with bladder outflow obstruction as urinary retention may occur.

DuoDote should be administered with caution in patients with partial pyloric stenosis because of the risk of complete pyloric obstruction.

Atropine may cause inspiration of bronchial secretions and formation of dangerous viscid plugs and may exacerbate chronic lung disease; monitor respiratory status.

Common adverse reactions of atropine include dryness of mouth, blurred vision, dry eyes, photophobia, confusion, headache, and dizziness among others. The common adverse reactions of pralidoxime chloride 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.

Muscle tightness and pain may occur at the injection site.

Succinylcholine and Mivacurium: Accelerated reversal of neuromuscular blocking effects may occur; monitor with concomitant administration.

Safety and effectiveness of DuoDote in pediatric patients weighing less than or equal to 41kg (90 pounds) have not been established.

Geriatric patients may be more susceptible to the effects of atropine.

Pralidoxime chloride can cause decreased renal function. Patients with severe renal impairment may require less frequent doses after the initial dose.

Pralidoxime Chloride Auto-Injector (pralidoxime chloride injection)

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 responders only after the individual has donned his mask and ensured that some or all of the symptoms of nerve agent poisoning are present.

It is also not known whether pralidoxime can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 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.