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DuoDote (Atropine and Pralidoxime Chloride Injection) side effects drug center

 

PROFESSIONAL

CONSUMER

SIDE EFFECTS

 

DuoDote Side Effects Center

What Is DuoDote?

DuoDote (atropine and pralidoxime chloride injection) is indicated for the treatment of poisoning by organophosphorus chemical nerve agents as well as organophosphorus insecticide poisoning. Patients should not rely on DuoDote to provide complete protection from chemical nerve agents and insecticide poisoning.

What Are Side Effects of DuoDote?

Common side effects from the use of DuoDote include:

Dosage for DuoDote

DuoDote is available as an auto-injector.

What Drugs, Substances, or Supplements Interact with DuoDote?

DuoDote is known to interact with barbiturates, morphine, theophylline, aminophylline, succinylcholine, reserpine, and phenothiazine-type tranquilizers, as well as succinylcholine and mivacurium.

DuoDote During Pregnancy or Breastfeeding

DuoDote has not been studied in pregnant women and should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Because many drugs are excreted in human milk, caution should be exercised when DuoDote is administered to a nursing woman.

Additional Information

DuoDote (atropine and pralidoxime chloride injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

 

DuoDote Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Some of the side effects of atropine and pralidoxime may be similar to the symptoms of poisoning. Your caregivers will watch you closely to determine whether your body is responding well to the medication, or if you are having any serious side effects.

Tell your caregivers right away if you have:

  • pounding heartbeats or fluttering in your chest;
  • chest pain spreading to your jaw or shoulder;
  • trouble swallowing;
  • painful or difficult urination;
  • little or no urination;
  • unusual changes in mood or behavior; or
  • blurred vision, tunnel vision, eye pain, or seeing halos around lights.

Side effects may be more likely in older adults.

Common side effects may include:

  • trouble breathing;
  • dry mouth;
  • dry eyes, vision changes, increased sensitivity to light;
  • nausea, vomiting;
  • fast heartbeats, increased blood pressure;
  • behavior changes, feeling excited or confused;
  • decreased urination;
  • headache, dizziness, drowsiness;
  • muscle weakness;
  • dry skin, rash; or
  • abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for DuoDote (Atropine and Pralidoxime Chloride Injection)

 

DuoDote Professional Information

SIDE EFFECTS

The following serious adverse reactions are described elsewhere in the labeling:

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.

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. Adverse cardiac reactions, including arrhythmias and myocardial infarction, have been reported with atropine [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY].

Larger doses of atropine may produce central nervous system effects such as restlessness, tremor, fatigue, locomotor difficulties, delirium, and hallucinations [see OVERDOSAGE].

Hypersensitivity reactions will occasionally occur, are usually seen as skin rashes, and may progress to exfoliation. Anaphylactic reaction and laryngospasm are rare.

Pralidoxime Chloride

Pralidoxime can cause blurred vision, diplopia and impaired accommodation, dizziness, headache, drowsiness, nausea, tachycardia, increased systolic and diastolic blood pressure [see CLINICAL PHARMACOLOGY], muscular weakness, dry mouth, emesis, rash, dry skin, hyperventilation, decreased renal function, and decreased sweating when given parenterally to normal adult volunteers who have not been exposed to anticholinesterase poisons.

In several cases of organophosphorus poisoning, excitement and manic behavior have occurred immediately following recovery of consciousness, in either the presence or absence of pralidoxime administration. However, similar behavior has not been reported in subjects given pralidoxime in the absence of organophosphorus poisoning.

Elevations in AST and/or ALT enzyme levels were observed in 1 of 6 normal adult volunteers given 1200 mg of pralidoxime intramuscularly, and in 4 of 6 adult volunteers given 1800 mg intramuscularly. Levels returned to normal in about two weeks. Transient elevations in creatine kinase were observed in all normal volunteers given the drug.

Injection Site

Muscle tightness and pain may occur at the injection site.

Inadvertent Injection

In cases where DuoDote is inadvertently administered to people who are not poisoned with nerve agent or organophosphorus insecticide, the following effects on their ability to function normally may occur.

Atropine 2 mg IM, roughly the equivalent of one DuoDote autoinjector, when given to healthy male volunteers, is associated with minimal effects on visual, motor, and mental functions, though unsteadiness walking and difficulty concentrating may occur. Atropine reduces body sweating and increases body temperature, particularly with exercise and under hot conditions.

Atropine 4 mg IM, roughly the equivalent of two DuoDote autoinjectors, when given to healthy male volunteers, is associated with impaired visual acuity, visual near point accommodation, logical reasoning, digital recall, learning, and cognitive reaction time. Ability to read is reduced or lost. Subjects are unsteady and need to concentrate on walking. These effects begin about 15 minutes to one hour or more post-dose.

Atropine 6 mg IM, roughly the equivalent of three DuoDote autoinjectors, when given to healthy male volunteers, is associated with the effects described above plus additional central effects including poor coordination, poor attention span, and visual hallucinations (colored flashes) in many subjects. Frank visual hallucinations, auditory hallucinations, disorientation, and ataxia occur in some subjects. Skilled and labor-intense tasks are performed more slowly and less efficiently. Decision making takes longer and is sometimes impaired.

It is unclear if the above data, obtained from studies of healthy adult subjects, can be extrapolated to other populations. In the elderly and patients with co-morbid conditions, the effects of ≥2 mg atropine on the ability to see, walk, and think properly are unstudied; effects may be greater in susceptible populations.

Patients who are mistakenly injected with DuoDote should avoid potentially dangerous overheating, avoid vigorous physical activity, and seek medical attention as soon as feasible.

Read the entire FDA prescribing information for DuoDote (Atropine and Pralidoxime Chloride Injection)

&Copy; DuoDote Patient Information is supplied by Cerner Multum, Inc. and DuoDote Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.