Atropen Auto-Injector (Atropine Sulfate) - Summary

SUMMARY

AtroPen^®
Auto-Injector
ATROPINE INJECTION

FOR USE IN NERVE AGENT AND INSECTICIDE POISONING ONLY

CAUTION! PRIMARY PROTECTION AGAINST EXPOSURE TO CHEMICAL NERVE AGENTS AND INSECTICIDE POISONING IS THE WEARING OF PROTECTIVE GARMENTS INCLUDING MASKS DESIGNED SPECIFICALLY FOR THIS USE.

INDIVIDUALS SHOULD NOT RELY SOLELY UPON ANTIDOTES SUCH AS ATROPINE AND PRALIDOXIME TO PROVIDE COMPLETE PROTECTION FROM CHEMICAL NERVE AGENTS AND INSECTICIDE POISONING.

SEEK IMMEDIATE MEDICAL ATTENTION AFTER INJECTION WITH ATROPEN^®.

A STERILE SOLUTION FOR INTRAMUSCULAR USE ONLY

Each prefilled auto-injector provides a dose of the antidote atropine in a self-contained unit, specially designed for self or caregiver administration. Four strengths of AtroPen^® are available; they are AtroPen^® 0.25 mg, AtroPen^® 0.5 mg, AtroPen^® 1 mg, and AtroPen^® 2 mg.

The AtroPen^® Auto-Injector is indicated for the treatment of poisoning by susceptible organophosphorous nerve agents having cholinesterase activity as well as organophosphorous or carbamate insecticides. The AtroPen ^® Auto-Injector should be used by persons who have had adequate training in the recognition and treatment of nerve agent or insecticide intoxication. Pralidoxime chloride may serve as an important adjunct to atropine therapy.

The AtroPen ^® is intended as an initial treatment of the muscarinic symptoms of insecticide or nerve agent poisonings (generally breathing difficulties due to increased secretions); definitive medical care should be sought immediately. The AtroPen^® Auto-Injector should be administered as soon as symptoms of organophosphorous or carbamate poisoning appear (usually tearing, excessive oral secretions, wheezing, muscle fasciculations, etc.). In moderate to severe poisoning, the administration of more than one AtroPen^® may be required until atropinization is achieved (flushing, mydriasis, tachycardia, dryness of the mouth and nose). (See DOSAGE AND ADMINISTRATION) In severe poisonings, it may also be desirable to concurrently administer an anticonvulsant if seizure is suspected in the unconscious individual since the classic tonic-clonic jerking may not be apparent due to the effects of the poison. In poisonings due to organophosphorous nerve agents and insecticides it may also be helpful to concurrently administer a cholinesterase reactivator such as pralidoxime chloride.

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NEWS HIGHLIGHTS

Published Studies Related to Atropen Auto-Injector (Atropine)

Anticholinergic premedication for flexible bronchoscopy: a randomized, double-blind, placebo-controlled study of atropine and glycopyrrolate. [2009.08]
BACKGROUND: Anticholinergic premedication is commonly used during flexible bronchoscopy, although the benefits are unproven and potential risks exist... CONCLUSIONS: Anticholinergic premedication may reduce airway secretions during flexible bronchoscopy but is not associated with any significant reduction in cough, patient discomfort, oxygen desaturation, or procedure time and is associated with greater hemodynamic fluctuations. Routine anticholinergic premedication may be unnecessary or even harmful during flexible bronchoscopy.

Atropine, hyoscine butylbromide, or scopolamine are equally effective for the treatment of death rattle in terminal care. [2009.07]
Death rattle is a frequent symptom (25%-50%) in the terminal stage of life, but there is neither standardized treatment nor prospective investigation performed on the effectiveness of anticholinergic drugs. The aim of the present study was to investigate the effectiveness of three different anticholinergic drugs in the treatment of death rattle in the terminal stage of life...

Treatment of severe amblyopia with weekend atropine: results from 2 randomized clinical trials. [2009.06]
PURPOSE: To determine the effectiveness of weekend atropine for severe amblyopia from strabismus, anisometropia, or both combined among children 3 to 12 years of age... CONCLUSIONS: Weekend atropine can improve visual acuity in children 3 to 12 years of age with severe amblyopia. Improvement may be greater in younger children.

Effect of topical atropine on astigmatism. [2009.06]
AIM: The aim of this study was to determine if topical atropine, used to retard axial length elongation and myopia progression, had any effect on ocular astigmatism... CONCLUSION: The use of atropine on a daily basis over 2 years did not have any clinically significant effect on astigmatism.

Atropine for prevention of cardiac dysrhythmias in patients with hepatocellular carcinoma undergoing percutaneous ethanol instillation: a randomized, placebo-controlled, double-blind trial. [2009.05]
INTRODUCTION: Percutaneous ethanol injection (PEI) is an established method in the treatment of hepatocellular carcinoma (HCC). During this procedure, severe cardiac bradyarrhythmias can occur. A preemptive injection of atropine is recommended by professional guidelines to prevent these dysrhythmias... CONCLUSION: In this randomized-controlled trial, a preprocedure atropine injection did not prevent the occurrence of bradyarrhythmias. Prophylactic use of atropine might not be effective and therefore cannot be recommended as a routine procedure. Clinicaltrials.gov-identifier: NCT00575523.

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Clinical Trials Related to Atropen Auto-Injector (Atropine)

Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old [Active, not recruiting]
The purpose of the study is:

- To compare the effectiveness and safety of weekend atropine augmented with a plano lens

for the sound eye versus weekend atropine alone for moderate amblyopia (20/40 to 20/100) in children 3 to less than 7 years old.

- To provide data on the response of severe amblyopia (20/125 to 20/400) to atropine

treatment with and without a plano lens.

Trial Comparing Daily Atropine Versus Weekend Atropine [Completed]
The goals of this study are:

- To compare the visual acuity outcome in the amblyopic eye after 17 weeks of daily use of

atropine versus weekend-only use of atropine.

- To compare the proportion of patients achieving a complete treatment response (defined

as amblyopic eye acuity >20/25 or equal to that of the sound eye in the absence of a reduction in the sound eye acuity from baseline) with daily atropine versus weekend-only atropine.

Myopia Control by Combining Auricular Acupoint and Atropine Eyedrops [Completed]
This study was designed to compare the difference of using atropine eyedrops alone from atropine combined with the stimulation of auricular acupoints therapy in reducing myopia progression.

Augmenting Atropine Treatment for Amblyopia in Children 3 to < 8 Years Old [Recruiting]
This study is designed to evaluate the effectiveness of adding a plano lens to weekend atropine after visual acuity has stabilized with weekend atropine but amblyopia is still present. Children ages 3 to <8 years with visual acuity of 20/50 to 20/400 in the amblyopic eye will be enrolled in a run-in phase with weekend atropine until no improvement, followed by randomization of eligible patients to weekend atropine treatment with a plano lens over the sound eye versus without a plano lens over the sound eye. The primary objective is to determine if adding a plano lens to weekend atropine will improve visual acuity in patients with amblyopia still present after visual acuity has stabilized with initial treatment.

A Study of Inhaled Atropine Sulfate in Healthy Adults [Recruiting]
MicroDose Defense Products, LLC is developing an atropine dry powder inhaler (ADPI). This pilot study compares the pharmacokinetics (PK) of inhaled dry powder atropine as delivered by the ADPI to atropine delivery from the AtroPen autoinjector.

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