Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Cardiovascular Risks [see Warnings and Precautions ( 5.1 )] Heat Injury [see Warnings and Precautions ( 5.2 )] Acute Glaucoma [see Warnings and Precautions ( 5.3 )] Urinary Retention [see Warnings and Precautions ( 5.4 )] Pyloric Stenosis [see Warnings and Precautions ( 5.5 )] Exacerbation of Chronic Lung Disease [see Warnings and Precautions ( 5.6 )] 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.
( 6.1 ) 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.
( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Meridian Medical Technologies ® , LLC at 1-833-739-0945 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Atropine Because DuoDote contains pralidoxime chloride, which may potentiate the effect of atropine, signs of atropinization may occur earlier than might be expected when atropine is used alone.
Common adverse reactions of atropine can be attributed to its antimuscarinic action.
These include dryness of the mouth, blurred vision, dry eyes, photophobia, confusion, headache, dizziness, tachycardia, palpitations, flushing, urinary hesitancy or retention, constipation, abdominal pain, abdominal distention, nausea and vomiting, loss of libido, and impotence.
Anhidrosis may produce heat intolerance and impairment of temperature regulation in a hot environment.
Dysphagia, paralytic ileus, acute angle closure glaucoma, maculopapular rash, petechial rash, and scarletiniform rash have also been reported.
5 WARNINGS AND PRECAUTIONS Cardiovascular (CV) Risks: Tachycardia, palpitations, premature ventricular contractions, flutter, fibrillation, etc.
Use caution in patients with known CV disease or conduction problems.
( 5.1 ) Heat Injury: May inhibit sweating and lead to hyperthermia;
avoid excessive exercising and heat exposure.
( 5.2 ) Acute Glaucoma: May precipitate in susceptible individuals.
Like all medications, Duodote can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: