Atropen
- Generic Name: atropine
- Brand Name: Atropen
Atropen (Atropine) side effects drug center
Atropen Side Effects Center
What Is AtroPen?
AtroPen (auto-injector atropine) Injection is an anticholinergic agent (muscarinic antagonist) used to treatment poisoning by organophosphorous nerve or carbamate insecticides. The AtroPen auto-injector should be used only by persons trained to recognize and treat nerve agent or insecticide intoxication. AtroPen is intended as an initial treatment of symptoms of insecticide or nerve agent poisonings (i.e., breathing difficulties due to increased secretions); definitive medical care should be sought immediately. AtroPen should be administered as soon as symptoms of poisoning appear (usually tearing, excessive oral secretions, wheezing, muscle fasciculations, etc.).
What Are Side Effects of AtroPen?
Common side effects of AtroPen include:
- pain at the injection site,
- dry mouth,
- blurred vision,
- sensitivity to light,
- confusion,
- headache,
- dizziness,
- rapid or irregular heart rate,
- flushing,
- urinary problems,
- constipation,
- bloating,
- nausea,
- vomiting,
- loss of sex drive,
- impotence,
- heat intolerance, and
- hypersensitivity reactions such as skin rash.
Dosage for AtroPen?
Different dose strengths of the AtroPen are available depending on the recipient's age and weight. In moderate to severe poisoning, the administration of more than one AtroPen may be required until atropinization is achieved.
What Drugs, Substances, or Supplements Interact with AtroPen?
AtroPen may interact with pralidoxime, and barbiturates. Tell your doctor all medications and supplements you use.
AtroPen During Pregnancy and Breastfeeding
During pregnancy, AtroPen should be used only if prescribed. This drug passes into breast milk in trace amounts. Consult your doctor before breastfeeding.
Additional Information
Our AtroPen (auto-injector atropine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Atropen Consumer Information
SIDE EFFECTS: Consult your pharmacist.In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Atropen (Atropine)
Atropen Professional Information
SIDE EFFECTS
The following serious adverse reactions are described elsewhere in the labeling:
- Cardiovascular Risks [see WARNINGS AND PRECAUTIONS]
- Heat Injury [see WARNINGS AND PRECAUTIONS]
- Acute Glaucoma [see WARNINGS AND PRECAUTIONS]
- Urinary Retention [see WARNINGS AND PRECAUTIONS]
- Pyloric Stenosis [see WARNINGS AND PRECAUTIONS]
- Exacerbation of Chronic Lung Disease [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity [see WARNINGS AND PRECAUTIONS]
The following adverse reactions associated with the use of atropine 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.
Adverse Reactions At Recommended Doses
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 scarlatiniform rash have also been reported. Adverse cardiac reactions, including arrhythmias and myocardial infarction, have been reported with atropine [see WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].
Larger doses of atropine may produce central nervous system effects such as restlessness, tremor, fatigue, locomotor difficulties, delirium, hallucinations, depression and ultimately, medullary paralysis and death [see OVERDOSAGE]. Large doses can also lead to circulatory collapse. In such cases, blood pressure declines and death due to respiratory failure may ensue following paralysis and coma.
Hypersensitivity
Hypersensitivity reactions will occasionally occur with atropine; these are usually seen as skin rashes and may progress to exfoliation. Anaphylactic reaction and laryngospasm have also occurred.
Pediatric Patients
Adverse events seen in pediatrics are similar to those that occur in adult patients although central nervous system complaints are often seen earlier and at lower doses.
Additional Adverse Reactions To Atropine By Organ System
The following adverse reactions were reported in published literature for atropine in both adults and children:
Cardiovascular
Sinus tachycardia, supraventricular tachycardia, junctional tachycardia, ventricular tachycardia, bradycardia, palpitations, ventricular arrhythmia, ventricular flutter, ventricular fibrillation, atrial arrhythmia, atrial fibrillation, atrial ectopic beats, ventricular premature contractions, bigeminal beats, trigeminal beats, nodal extrasystole, ventricular extrasystole, supraventricular extrasystole, asystole, cardiac syncope, prolongation of sinus node recovery time, cardiac dilation, left ventricular failure, myocardial infarction, intermittent nodal rhythm (no P wave), prolonged P wave, shortened PR segment, R on T phenomenon, shortened RT duration, widening and flattening of QRS complex, prolonged QT interval, flattening of T wave, repolarization abnormalities, altered ST-T waves, retrograde conduction, transient atrioventricular (AV) dissociation, increased blood pressure, decreased blood pressure, labile blood pressure, weak or impalpable peripheral pulses.
Eye
Mydriasis, blurred vision, pupils poorly reactive to light, photophobia, decreased contrast sensitivity, decreased visual acuity, decreased accommodation, cycloplegia, strabismus, heterophoria, cyclophoria, acute angle closure glaucoma, conjunctivitis, keratoconjunctivitis sicca, blindness, tearing, dry eyes/dry conjunctiva, irritated eyes, crusting of eyelid, blepharitis.
Gastrointestinal
Nausea, abdominal pain, paralytic ileus, decreased bowel sounds, distended abdomen, vomiting, delayed gastric emptying, decreased food absorption, dysphagia.
General
Hyperpyrexia, lethargy, somnolence, chest pain, excessive thirst, weakness, syncope, insomnia, tongue chewing, dehydration, feeling hot, injection site reaction.
Immunologic
Anaphylactic reaction.
Special Investigations
Leukocytosis, hyponatremia, elevated blood urea nitrogen (BUN), elevated hemoglobin, elevated erythrocytes, low hemoglobin, hypoglycemia, hyperglycemia, hypokalemia, increase in photic stimulation on electroencephalogram (EEG), signs of drowsiness on EEG, runs of alpha waves on EEG, alpha waves (EEG) blocked upon opening eyes.
Metabolic
Failure to feed.
Central Nervous System
Ataxia, hallucinations (visual or aural), seizures (generally tonic-clonic), abnormal movements, coma, confusion, stupor, dizziness, amnesia, headache, diminished tendon reflexes, hyperreflexia, muscle twitching, opisthotonos, Babinski's reflex/Chaddock's reflex, hypertonia, dysmetria, muscle clonus, sensation of intoxication, difficulty concentrating, vertigo, dysarthria.
Psychiatric
Agitation, restlessness, delirium, paranoia, anxiety, mental disorders, mania, withdrawn behavior, behavior changes.
Genitourinary
Difficulty in micturition, urine urgency, distended urinary bladder, urine retention, bed-wetting.
Pulmonary
Tachypnea, slow respirations, shallow respirations, breathing difficulty, labored respirations, inspiratory stridor, laryngitis, laryngospasm, pulmonary edema, respiratory failure, subcostal recession.
Dermatologic
Dry mucous membranes, dry warm skin, flushed skin, oral lesions, dermatitis, petechiae, rash, macular rash, papular rash, maculopapular rash, scarlatiniform rash, erythematous rash, sweating/moist skin, cold skin, cyanosed skin, salivation.
Injection Site
Muscle tightness and pain may occur at the injection site.
Inadvertent Injection
In cases where ATROPEN 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. Patients with cardiac disease may be at risk for serious adverse events, including death.
Atropine 2 mg IM, 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, 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, when given to healthy male volunteers, is associated with the effects described above plus additional central nervous system 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 ATROPEN should avoid potentially dangerous overheating, avoid vigorous physical activity, and seek medical attention as soon as feasible.
Adverse Reactions Observed In Pediatric Patients After Inappropriate Administration Of ATROPEN
Amitai et el (JAMA 1990) evaluated the safety of ATROPEN 0.5 mg, 1 mg, and 2 mg in a case series of 240 children who received ATROPEN inappropriately (i.e., no nerve agent exposure) during the 1990 Gulf War Period. Overall, severity of atropinization followed a nonlinear correlation with dose. Estimated doses up to 0.045 mg/kg produced no signs of atropinization. Estimated doses between 0.045 mg/kg to 0.175 mg/kg and even greater than 0.175 mg/kg were associated with mild and severe effects, respectively. Actual dosage received by children may have been considerably lower than estimated since incomplete injection in many cases was suspected. Regardless, adverse events reported were generally mild and self-limited. Few children required hospitalization. Adverse reactions reported were dilated pupils (43%), tachycardia (39%), dry membranes (35%), flushed skin (20%), temperature 37.8°C or 100°F (4%), and neurologic abnormalities (5%). There was also local pain and swelling. In 91 children with electrocardiograms (ECGs), no abnormalities were noted other than sinus tachycardia; 22 children had severe tachycardia of 160 bpm to 190 bpm. Neurologic abnormalities consisted of irritability, agitation, confusion, lethargy, and ataxia
Read the entire FDA prescribing information for Atropen (Atropine)
&Copy; Atropen Patient Information is supplied by Cerner Multum, Inc. and Atropen Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.