Overview

Atropine is an alkaloid originally synthesized from Atropa belladonna. It is a racemic mixture of d-and l-hyoscyamine, of which only l-hyoscyamine is pharmacologically active. Atropine is generally available as a sulfate salt and can be administered by intravenous, subcutaneous, intramuscular, intraosseous, endotracheal and ophthalmic methods. Oral atropine is only available in combination products. Atropine is a competitive, reversible antagonist of muscarinic receptors that blocks the effects of acetylcholine and other choline esters. It has a variety of therapeutic applications, including pupil dilation and the treatment of anticholinergic poisoning and symptomatic bradycardia in the absence of reversible causes. Atropine is a relatively inexpensive drug and is included in the World Health Organization List of Essential Medicines.

Indication

The intravenous, intramuscular, subcutaneous, intraosseous and endotracheal use of atropine is indicated for the temporary blockade of severe or life-threatening muscarinic effects. The intramuscular use of atropine in the form of a pen injector is indicated for the treatment of poisoning by susceptible organophosphorus nerve agents having cholinesterase activity as well as organophosphorus or carbamate insecticides in adult and pediatric patients. The ophthalmic use of atropine is indicated for mydriasis, cycloplegia, and penalization of the healthy eye in the treatment of amblyopia. In combination with difenoxin or diphenoxylate (tablets for oral use), atropine is indicated as adjunctive therapy in the management of acute nonspecific diarrhea.

Associated Conditions

Amblyopia
Atrioventricular Heart-block
Bradycardia
Bronchospasm
Crying
Detrusor Hyperreflexia
Excessive bronchial secretion
Hypertonic uterine contraction
Hypertonicity of the small intestine
Ocular Inflammation
Parkinsonism
Peptic Ulcer
Poisoning by parasympathomimetics (cholinergics)
Poisoning caused by mushrooms
Poisoning caused by organophosphate anticholinesterase nerve agents
Poisoning caused by organophosphorus pesticides
Pylorospasm
Rhinorrhoea
Sinus Bradycardia
Spasms
Toxic effect of organophosphate and carbamate
Hypermobility of the colon
Laughing
Life-threatening muscarinic side effects
Muscarinic side effects
Severe muscarinic side effects

Research Report

Published: Jul 28, 2025

Atropine (DB00572): A Comprehensive Pharmacological and Clinical Monograph

Section 1: Introduction and Chemical Profile

1.1 Overview and Historical Context

Atropine is a tropane alkaloid and a potent, non-selective anticholinergic agent that functions as a competitive antagonist at muscarinic acetylcholine receptors. It is classified as a small molecule drug with the DrugBank ID DB00572.[1] As a cornerstone of modern pharmacology, its applications span numerous medical specialties, including emergency medicine, cardiology, anesthesiology, and ophthalmology.[2] Its profound importance in global health is underscored by its inclusion in the World Health Organization (WHO) List of Essential Medicines, a compilation of the most efficacious, safe, and cost-effective medications required for a basic health system.[1]

The history of Atropine is a compelling narrative that traces the journey of a natural product from ancient folk remedy to a scientifically validated and indispensable therapeutic agent. The physiological effects of plants containing Atropine have been recognized for millennia. As far back as the last century B.C., Cleopatra reportedly used extracts from the Egyptian henbane plant, which contains tropane alkaloids, to dilate her pupils for cosmetic allure.[4] This practice continued into the Renaissance, when women used the juice from the berries of the

Atropa belladonna plant for the same purpose. This cosmetic application gave the plant its name, which translates to "beautiful lady" in Italian.[4]

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Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
"Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial	2006/05/03	NCT00320892	Not Applicable	Terminated	Soroka University Medical Center
Trial Comparing Patching Versus Atropine for Amblyopia in 7 to < 13 Year Olds	2006/04/18	NCT00315328	Phase 3	Completed	Jaeb Center for Health Research
Trial Comparing Atropine to Atropine Plus a Plano Lens for the Sound Eye for Amblyopia in Children 3 to <7 Years Old	2006/04/18	NCT00315302	Phase 3	Completed	Jaeb Center for Health Research
Tacrolimus and Sirolimus as Prophylaxis After Allogenic Non-myeloablative Peripheral Blood Stem Cell Transplantation	2006/01/26	NCT00282282	Phase 2	Completed	Dana-Farber Cancer Institute
Analysis of Atropine and Propranolol Induced Changes	2005/11/10	NCT00251602	Phase 1	Completed	National Institute on Aging (NIA)
Allogeneic Stem Cell Transplantation Following Chemotherapy in Patients With Hemoglobinopathies	2005/09/12	NCT00153985	Phase 2	Completed	Dana-Farber Cancer Institute
Effects of Epinephrine and Intravenous (I.V.) Needle on Cardiopulmonary Resuscitation (CPR) Outcome	2005/07/21	NCT00121524	Phase 2	Completed	Petter Andreas Steen
Trial Comparing Daily Atropine Versus Weekend Atropine	2004/10/22	NCT00094614	Phase 4	Completed	Jaeb Center for Health Research
An Evaluation of Treatment of Amblyopia in Children 7 To <18 Years Old	2004/10/22	NCT00094692	Phase 3	Completed	Jaeb Center for Health Research
Amblyopia (Lazy Eye) Treatment Study	2002/05/22	NCT00001864	Phase 3	Completed	National Eye Institute (NEI)

FDA Drug Approvals

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Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Diphenoxylate Hydrochloride and Atropine Sulfate	Atlantic Biologicals Corps	17856-3194	ORAL	0.025 mg in 5 mL	9/8/2016
Donnatal	PBM Pharmaceuticals Inc.	66213-422	ORAL	0.0194 mg in 5 mL	12/3/2013
Belladonna Alkaloids with Phenobartbital	Rebel Distributors Corp	21695-890	ORAL	0.0194 mg in 1 1	11/30/2010
Atropine Sulfate	Bausch & Lomb Incorporated	24208-965	OPHTHALMIC	10 mg in 1 mL	3/3/2022
Diphenoxylate Hydrochloride and Atropine Sulfate	Redpharm Drug Inc.	67296-1485	ORAL	0.025 mg in 1 1	2/15/2023
ATROPINE SULFATE	Accord Healthcare Inc.	16729-525	INTRAVENOUS	0.4 mg in 1 mL	3/16/2023
Atropine Sulfate	Hikma Pharmaceuticals USA Inc.	0641-6006	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS	0.4 mg in 1 mL	3/24/2021
ATROPEN Auto-Injector	Meridian Medical Technologies LLC	11704-105	INTRAMUSCULAR	1 mg in 0.7 mL	3/22/2017
Donnatal	Rebel Distributors Corp	42254-268	ORAL	0.0194 mg in 1 1	10/17/2011
Diphenoxylate Hydrochloride and Atropine Sulfate	Greenstone LLC	59762-1061	ORAL	0.025 mg in 1 1	9/12/2023

EMA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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Health Canada Drug Approvals

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Philippines FDA Drug Approvals

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Saudi SFDA Drug Approvals

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Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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