Duodote

DuoDote is indicated for the treatment of poisoning by organophosphorus nerve agents as well as organophosphorus insecticides in adults and pediatric patients weighing more than 41 kg (90 pounds).

• DuoDote is intended as an initial treatment as soon as symptoms appear; definitive medical care should be sought immediately. (
  2.1 Important Administration Information

  • Three (3) single-dose DuoDote autoinjectors should be available for use in each patient (including healthcare providers) at risk for organophosphorus poisoning; one (1) for mild symptoms plus two (2) more for severe symptoms
    [see Dosage and Administration ]
    . Note that individuals may not have all symptoms included under the mild or severe symptom category.
  • Only administer DuoDote to patients experiencing symptoms of organophosphorus poisoning in a situation where exposure is known or suspected. The DuoDote autoinjector is intended as an initial treatment of the symptoms of organophosphorus nerve agent or insecticide poisonings as soon as symptoms appear; definitive medical care should be sought immediately.
  • The DuoDote autoinjector should be administered by healthcare providers who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication.
  • Close supervision of all treated patients is indicated for at least 48 to 72 hours.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
    [see Dosage Forms and Strengths ]
    .
  )
• Dosage for Mild Symptoms: If the patient experiences two or more mild symptoms, administer one injection intramuscularly into the mid-lateral thigh. If, at any time after the first dose, the patient develops any of the severe symptoms, administer two additional injections intramuscularly in rapid succession. (
  2.2 Dosage Information

  Dosage for Mild Symptoms in Adults and Pediatric Patients Weighing More Than 41 kg (90 Pounds)

  First Dose

  : If the patient experiences two or more mild symptoms of nerve agent or insecticide exposure listed in Table 1, administer one (1) single-dose DuoDote injection intramuscularly into the mid-lateral thigh.

  Additional Doses

  : If, at any time after the first dose, the patient develops any of the severe symptoms listed in Table 1, administer two (2) additional single-dose DuoDote injections intramuscularly in rapid succession.

  Wait 10 to 15 minutes for DuoDote to take effect. If, after 10 to 15 minutes, the patient does not develop any of the severe symptoms listed in Table 1, no additional DuoDote injections are recommended.

  Dosage for Severe Symptoms in Adults and Pediatric Patients Weighing More Than 41 kg (90 Pounds)

  If a patient has any of the severe symptoms listed in Table 1, immediately administer three (3) single-dose DuoDote injections intramuscularly into the patient's mid-lateral thigh in rapid succession.

  Table 1. Common Symptoms of Organophosphorus Exposure

  Mild Symptoms	Severe Symptoms
  Blurred vision, miosis Excessive, unexplained teary eyes Excessive, unexplained runny nose Increased salivation such as sudden drooling Chest tightness or difficulty breathing Tremors throughout the body or muscular twitching Nausea and/or vomiting Unexplained wheezing, coughing or increased airway secretions Acute onset of stomach cramps Tachycardia or bradycardia	Strange or confused behavior Severe difficulty breathing or copious secretions from lungs/airway Severe muscular twitching and general weakness Involuntary urination and defecation Convulsions Unconsciousness
  )
• Dosage for Severe Symptoms: If a patient has any of the severe symptoms, immediately administer three injections intramuscularly into the patient's mid-lateral thigh in rapid succession. (
  2.2 Dosage Information

  Dosage for Mild Symptoms in Adults and Pediatric Patients Weighing More Than 41 kg (90 Pounds)

  First Dose

  : If the patient experiences two or more mild symptoms of nerve agent or insecticide exposure listed in Table 1, administer one (1) single-dose DuoDote injection intramuscularly into the mid-lateral thigh.

  Additional Doses

  : If, at any time after the first dose, the patient develops any of the severe symptoms listed in Table 1, administer two (2) additional single-dose DuoDote injections intramuscularly in rapid succession.

  Wait 10 to 15 minutes for DuoDote to take effect. If, after 10 to 15 minutes, the patient does not develop any of the severe symptoms listed in Table 1, no additional DuoDote injections are recommended.

  Dosage for Severe Symptoms in Adults and Pediatric Patients Weighing More Than 41 kg (90 Pounds)

  If a patient has any of the severe symptoms listed in Table 1, immediately administer three (3) single-dose DuoDote injections intramuscularly into the patient's mid-lateral thigh in rapid succession.

  Table 1. Common Symptoms of Organophosphorus Exposure

  Mild Symptoms	Severe Symptoms
  Blurred vision, miosis Excessive, unexplained teary eyes Excessive, unexplained runny nose Increased salivation such as sudden drooling Chest tightness or difficulty breathing Tremors throughout the body or muscular twitching Nausea and/or vomiting Unexplained wheezing, coughing or increased airway secretions Acute onset of stomach cramps Tachycardia or bradycardia	Strange or confused behavior Severe difficulty breathing or copious secretions from lungs/airway Severe muscular twitching and general weakness Involuntary urination and defecation Convulsions Unconsciousness
  )

Each single-dose DuoDote autoinjector contains the following in two separate chambers:

• front chamber (visible): a clear, colorless to yellow, sterile solution of atropine (2.1 mg/0.7 mL)
• back chamber (not visible): a clear, colorless to yellow, sterile solution of pralidoxime chloride (600 mg/2 mL) equivalent to pralidoxime (476.6 mg/2 mL)

When activated, DuoDote sequentially administers both drugs intramuscularly through a single needle in one injection.

• Geriatric patients may be more susceptible to the effects of atropine. (
  8.5 Geriatric Use

  Geriatric patients may be more susceptible to the effects of atropine

  [see Clinical Pharmacology ].
  )

• Cardiovascular (CV) Risks:
  Tachycardia, palpitations, premature ventricular contractions, flutter, fibrillation, etc. Use caution in patients with known CV disease or conduction problems. (
  5.1 Cardiovascular Risks

  Cardiovascular adverse reactions reported in the literature for atropine include, but are not limited to, sinus tachycardia, palpitations, premature ventricular contractions, atrial flutter, atrial fibrillation, ventricular flutter, ventricular fibrillation, cardiac syncope, asystole, and myocardial infarction. 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. DuoDote should be used with caution in patients with known cardiovascular disease or cardiac conduction problems.
  )
• Heat Injury:
  May inhibit sweating and lead to hyperthermia; avoid excessive exercising and heat exposure. (
  5.2 Heat Injury

  Atropine may inhibit sweating which, in a warm environment or with excessive exercise, can lead to hyperthermia and heat injury. To the extent feasible, avoid excessive exercise and heat exposure

  [see Overdosage ].
  )
• Acute Glaucoma:
  May precipitate in susceptible individuals. (
  5.3 Acute Glaucoma

  Atropine should be administered with caution in patients at risk for acute glaucoma.
  )
• Urinary Retention
  : Administer with caution in patient with bladder outflow obstruction. (
  5.4 Urinary Retention

  Atropine should be administered with caution in patients with clinically significant bladder outflow obstruction because of the risk of urinary retention.
  )
• Pyloric Stenosis:
  May convert into complete obstruction. (
  5.5 Pyloric Stenosis

  Atropine should be administered with caution in patients with partial pyloric stenosis because of the risk of complete pyloric obstruction.
  )
• Exacerbation of Chronic Lung Disease:
  Atropine may cause inspissation of bronchial secretions and formation of dangerous viscid plugs in individuals with chronic lung disease; monitor respiratory status. (
  5.6 Exacerbation of Chronic Lung Disease

  Atropine may cause inspissation of bronchial secretions and formation of dangerous viscid plugs in individuals with chronic lung disease. Respiratory status should be monitored in individuals with chronic lung disease following administration of DuoDote.
  )