ATNAA atropine and pralidoxime chloride Auto-Injector
Generic: ATROPINE AND PRALIDOXIME CHLORIDE
Basic Information
Manufacturer
Meridian Medical Technologies, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAMUSCULAR
FDA Set ID
596c7a8f-27cd-4de2-9491-476f43570b8b
Indications & Usage
1 INDICATIONS AND USAGE ATNAA is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity in adults.
ATNAA, a combination of atropine, a cholinergic muscarinic antagonist, and pralidoxime chloride, a cholinesterase reactivator, is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity in adults.
( 1 )
ATNAA, a combination of atropine, a cholinergic muscarinic antagonist, and pralidoxime chloride, a cholinesterase reactivator, is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having anticholinesterase activity in adults.
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Adverse Reactions
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 ATNAA 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 (5.1) and Clinical Pharmacology (12.2) ] .
Larger doses of atropine may produce central nervous system effects such as restlessness, tremor, fatigue, locomotor difficulties, delirium, and hallucinations [see Overdosage (10.1) ] .
Hypersensitivity reactions will occasionally occur; these are usually seen as skin rashes, and may progress to exfoliation.
Anaphylactic reaction and laryngospasm are rare.
6.2 Pralidoxime Chloride Pralidoxime chloride can cause blurred vision, diplopia and impaired accommodation, dizziness, headache, drowsiness, nausea, tachycardia, increased systolic and diastolic blood pressure [see Clinical Pharmacology 12.2) ], 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 chloride administration.
However, similar behavior has not been reported in subjects given pralidoxime chloride 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 chloride 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.
6.3 Injection Site Muscle tightness and pain may occur at the injection site.
6.4 Inadvertent Injection In cases where ATNAA is inadvertently administered to service members who are not poisoned with susceptible organophosphorus nerve agents having anticholinesterase activity, the following effects on their ability to function normally may occur.
Atropine 2 mg IM , roughly the equivalent of one ATNAA injection, 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 ATNAA injections, 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 ATNAA injections, 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 male subjects, can be extrapolated to other populations.
In the elderly and individuals 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.
Service members who are mistakenly injected with ATNAA should avoid potentially dangerous overheating, avoid vigorous physical activity, and seek medical attention as soon as feasible.
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 ATNAA 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 (5.1) and Clinical Pharmacology (12.2) ] .
Larger doses of atropine may produce central nervous system effects such as restlessness, tremor, fatigue, locomotor difficulties, delirium, and hallucinations [see Overdosage (10.1) ] .
Hypersensitivity reactions will occasionally occur; these are usually seen as skin rashes, and may progress to exfoliation.
Anaphylactic reaction and laryngospasm are rare.
6.2 Pralidoxime Chloride Pralidoxime chloride can cause blurred vision, diplopia and impaired accommodation, dizziness, headache, drowsiness, nausea, tachycardia, increased systolic and diastolic blood pressure [see Clinical Pharmacology 12.2) ], 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 chloride administration.
However, similar behavior has not been reported in subjects given pralidoxime chloride 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 chloride 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.
6.3 Injection Site Muscle tightness and pain may occur at the injection site.
6.4 Inadvertent Injection In cases where ATNAA is inadvertently administered to service members who are not poisoned with susceptible organophosphorus nerve agents having anticholinesterase activity, the following effects on their ability to function normally may occur.
Atropine 2 mg IM , roughly the equivalent of one ATNAA injection, 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 ATNAA injections, 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 ATNAA injections, 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 male subjects, can be extrapolated to other populations.
In the elderly and individuals 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.
Service members who are mistakenly injected with ATNAA should avoid potentially dangerous overheating, avoid vigorous physical activity, and seek medical attention as soon as feasible.