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DuoDote® Auto-Injector (Atropine and Pralidoxime Chloride Injection) by Meridian Medical Technologies

Companies & Organizations:

Use DuoDote in the presence of life-threatening poisoning by organophosphorus nerve agents.

 

Indication:

 

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).

 

KEY PRODUCT SPECIFICATIONS:

 

NSN                                       6505-01-581-1327

NDC                                       11704-620-01

Delivers                                  2.1 mg atropine in 0.7 mL and 600 mg pralidoxime chloride

                                               in 2 mL sequentially through a single needle using the

                                               two-chambered BinaJect® drug delivery system.

Length of Unit                        145 mm

Diameter of Unit                    19 mm

Needle Gauge                       23

Needle Length                       21 mm

Administration Type               Intramuscular injection

Packaged                              1 auto-injector per box with instructions; package insert

Packaging for Shipping          30 units per shipper box (286 mm x 213 mm x 210 mm), weighing 2.3 kg

Storage                                  Store at 25°C (77°F); excursions permitted to 15°C-30°C

                                               (59°F-86°F) [See USP Controlled Room Temperature].

                                               Keep from freezing. Protect from light.

Prescription Required             Yes

 

IMPORTANT SAFETY INFORMATION AND INDICATION

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.

 

INDICATION

 

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).

Defense Products & Services: DuoDote® Auto-Injector (Atropine and Pralidoxime Chloride Injection) by Meridian Medical Technologies
Companies & Organizations: 
Description: DuoDote® Auto-Injector (Atropine and Pralidoxime Chloride Injection)
Source of Information: Meridian Medical Technologies Inc