ATROPINE SUMMARY
Atropine Sulfate
Injection, USP
Atropine Sulfate Injection, USP is a sterile, nonpyrogenic isotonic solution of atropine sulfate monohydrate in water for injection with sodium chloride sufficient to render the solution isotonic. It is administered parenterally by subcutaneous, intramuscular or intravenous injection. Each milliliter (mL) contains atropine sulfate, monohydrate 0.1 mg (adult strength) or 0.05 mg (pediatric strength), and sodium chloride, 9 mg. May contain sodium hydroxide and/or sulfuric acid for pH adjustment 0.308 mOsmol/mL (calc.). pH 4.2 (3.0 to 6.5). The solution contains no bacteriostat, antimicrobial agent or added buffer (except for pH adjustment) and is intended for use only as a single-dose injection. When smaller doses are required the unused portion should be discarded. Atropine Sulfate Injection is a parenteral anticholinergic agent and muscarinic antagonist.
Atropine Sulfate Injection, USP, is indicated when excessive (or sometimes normal) muscarinic effects are judged to be life threatening or are producing symptoms severe enough to call for temporary, reversible muscarinic blockade. Examples, not an exhaustive list, of such possible uses are: (1) as an antisialoagogue when reduction of secretions of the respiratory tract are thought to be needed; its routine use as a preanesthetic agent is discouraged, (2) to blunt the increased vagal tone (decreased pulse and blood pressure) produced by intra-abdominal traction or ocular muscle traction, its routine use to prevent such events is discouraged, (3) to temporarily increase heart rate or decrease AV-block until definitive intervention can take place, when bradycardias or AV-block are judged to be hemodynamically significant and thought to be due to excess vagal tone, (4) as an antidote for inadvertent overdose of cholinergic drugs or for cholinesterase poisoning such as from organophosphorus insecticides, (5) as an antidote for the “rapid” type of mushroom poisoning due to the presence of the alkaloid, muscarine, in certain species of fungus such as Amanita muscaria, and (6) to alleviate the muscarinic side effects of anticholinesterase drugs used for reversal of neuromuscular blockade.
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NEWS HIGHLIGHTS
Published Studies Related to 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.
Clinical Trials Related to 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 Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds [Active, not recruiting]
The purpose of this study is:
- To compare the effectiveness of weekend atropine plus near activities and daily patching
plus near activities for moderate amblyopia (20/40 to 20/100) and severe amblyopia
(20/125 to 20/400) in improving vision in the amblyopic eye of 7 to <13 year olds.
- To determine the maximum improvement in vision of the amblyopic eye with each
treatment.
- To determine whether amblyopia is associated with structural abnormalities of optic
nerve fiber layer.
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.
Atropine for Prevention of Dysrhythmias Caused by Percutaneous Ethanol Instillation for Hepatoma Therapy [Completed]
Ultrasound guided percutaneous ethanol injection (PEI) is an established method in the
treatment of hepatocellular carcinoma (HCC) and considered a safe procedure with severe
complications occurring rarely. Previous studies revealed, that the occurrence of bradycardia
and sinuatrial blockage is quite frequent during ethanol instillation sometimes accompanied
by clinical complications such as unconsciousness, respiratory arrest or seizure like
symptoms. Study purpose is to evaluate whether the use of i. v. Atropine before starting
ethanol instillation can prevent dysrhythmias during instillation. Study design: randomized,
placebo controlled, double blinded study. Atropine or saline solution will be administered
intravenously to 40 patients immediately before starting percutaneous ethanol instillation. A
6 line ECG with limb leads will be recorded at rest and during ethanol instillation to reveal
possibly occurring dysrhythmias.
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.
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