Atropine and Pralidoxime

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, a combination of atropine, a cholinergic muscarinic antagonist, and pralidoxime chloride, a cholinesterase reactivator, 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).

Atropine Atropine competitively blocks the effects of acetylcholine, including excess acetylcholine due to organophosphorus poisoning, at muscarinic cholinergic receptors on smooth muscle, cardiac muscle, secretory gland cells, and in peripheral autonomic ganglia and the central nervous system. Pralidoxime Pralidoxime reactivates acetylcholinesterase which has been inactivated by phosphorylation due to an organophosphorus nerve agent or insecticide. However, pralidoxime does not reactivate acetylcholinesterase inactivated by all organophosphorus nerve agents (e.g., soman). Pralidoxime cannot reactivate phosphorylated acetylcholinesterases that have undergone a further chemical reaction known as “aging.” Reactivated acetylcholinesterase hydrolyzes excess acetylcholine resulting from organophosphorus poisoning to help restore impaired cholinergic neural function.

DuoDote is intended as an initial treatment as soon as symptoms appear, definitive medical care should be sought immediately. 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. 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.

None. None.

Cardiovascular (CV) Risks: Tachycardia, palpitations, premature ventricular contractions, flutter, fibrillation, etc. Use caution in patients with known CV disease or conduction problems. Heat Injury: May inhibit sweating and lead to hyperthermia, avoid excessive exercising and heat exposure. Acute Glaucoma: May precipitate in susceptible individuals. Urinary Retention: Administer with caution in patient with bladder outflow obstruction. Pyloric Stenosis: May convert into complete 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.

The following serious adverse reactions are described elsewhere in the labeling: Cardiovascular Risks Heat Injury Acute Glaucoma Urinary Retention Pyloric Stenosis Exacerbation of Chronic Lung Disease The following adverse reactions associated with the use of atropine and pralidoxime chloride were identified in the literature. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Common adverse reactions of atropine include dryness of mouth, blurred vision, dry eyes, photophobia, confusion, headache, and dizziness among others.

Succinylcholine and Mivacurium: Accelerated reversal of neuromuscular blocking effects may occur, monitor with concomitant administration. Succinylcholine and Mivacurium Since pralidoxime in DuoDote reactivates cholinesterases and succinylcholine and mivacurium are metabolized by cholinesterases, patients with organophosphorus nerve agent or organophosphorus insecticide poisoning who have received DuoDote may exhibit accelerated reversal of the neuromuscular blocking effects of succinylcholine and mivacurium (relative to poisoned patients who have not received pralidoxime). Monitor for neuromuscular effects with concomitant administration.

Store at 25ºC (77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Keep from freezing. Protect from light.