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
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]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/09/16 | Not Applicable | Recruiting | |||
2025/07/31 | Not Applicable | Not yet recruiting | Jaeb Center for Health Research | ||
2025/06/19 | Phase 3 | Not yet recruiting | Ocus Innovation Ireland Limited | ||
2024/12/10 | Not Applicable | Completed | Beijing Tongren Hospital | ||
2024/11/27 | Phase 3 | Recruiting | Oupushifang Pharmaceutical Technology Co., Ltd. | ||
2024/11/20 | Phase 3 | Completed | |||
2024/10/31 | Not Applicable | Recruiting | |||
2024/08/30 | Phase 2 | Recruiting | |||
2024/06/10 | Phase 4 | Recruiting | |||
2024/05/29 | Phase 4 | Active, not recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Accord Healthcare Inc. | 16729-526 | INTRAVENOUS | 1 mg in 1 mL | 3/16/2023 | |
| Medical Purchasing Solutions, LLC | 71872-7002 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ENDOTRACHEAL | 0.1 mg in 1 mL | 10/13/2022 | |
| ATLANTIC BIOLOGICALS CORP. | 17856-0162 | ORAL | 0.0194 mg in 5 mL | 6/15/2018 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1509 | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 1 mg in 1 mL | 6/14/2021 | |
| Lohxa | 70166-630 | ORAL | 0.025 mg in 5 mL | 9/10/2019 | |
| Winder Laboratories, LLC | 75826-118 | ORAL | 0.0194 mg in 1 1 | 12/27/2019 | |
| HF Acquisition Co LLC, DBA HealthFirst | 51662-1626 | INTRAVENOUS | 1 mg in 1 mL | 1/28/2024 | |
| A-S Medication Solutions | 50090-5592 | ORAL | 0.025 mg in 1 1 | 2/25/2020 | |
| Bryant Ranch Prepack | 63629-1934 | ORAL | 0.025 mg in 1 1 | 11/3/2017 | |
| Physicians Total Care, Inc. | 54868-0032 | ORAL | 0.025 mg in 1 1 | 1/25/2011 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| ATROPINE INJECTION BP 600 mcg/ml | SIN07360P | INJECTION | 600 mcg/ml | 3/15/1993 | |
| SUN-DIANOX TABLET | SIN09095P | TABLET | 0.025 mg | 12/20/1996 | |
| ALCON ATROPINE SULFATE EYE DROPS 1% | SIN04140P | SOLUTION | 1% | 4/17/1990 | |
| DHAMOTIL TABLET | SIN05379P | TABLET, FILM COATED | 0.025 mg | 1/29/1991 | |
| MARTINDALE PHARMA ATROPINE SULFATE SOLUTION FOR INJECTION 600 MCG/ML | SIN15611P | INJECTION, SOLUTION | 600 mcg/ml | 1/11/2019 | |
| ATROPINE SULPHATE INJECTION 0.6 mg/ml | ATLANTIC LABORATORIES CORPN LTD | SIN03441P | INJECTION | 0.6 mg/ml | 6/16/1989 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| ATROJEAN EYE DROPS 0.01% W/V | N/A | N/A | N/A | 11/12/2024 | |
| DHAMOTIL TAB | N/A | N/A | N/A | 3/10/1989 |
TGA Drug Approvals
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| HOMEOPATHIC MEDICINE (S #391) DPS 30C | total health centre | 02082721 | Drops - Oral | 30 C / ML | 12/31/1994 |
| ATROPINE SULFATE INJECTION | 02426277 | Solution - Subcutaneous
,
Intravenous
,
Intramuscular | 1 MG / 5 ML | 1/20/2015 | |
| DIBAN CAP | wyeth-ayerst canada inc. | 02041626 | Capsule - Oral | 9.7 MCG | 2/18/1998 |
| ATROPINE | pharma stulln inc. | 02023695 | Solution - Ophthalmic | 1 % | 12/31/1994 |
| ATROPINE SULPHATE 1% - LIQ OPH | rivex ophthalmics inc. | 02212951 | Liquid - Ophthalmic | 1 % | 5/17/1997 |
| ATROPINE SULFATE INJECTION USP | 02472171 | Solution - Intravenous
,
Intramuscular
,
Subcutaneous | 0.5 MG / 5 ML | 3/25/2020 | |
| ALCON ATROPINE | Alcon Canada Inc | 00035017 | Solution - Ophthalmic | 1 % / W/V | 12/31/1964 |
| SPASCUPREEL INJEEL LIQ | 02026384 | Liquid - Oral | 6 D / AMP | 12/31/1993 | |
| SPASCUPREEL TABLETS | 02029723 | Tablet - Oral | 6 D | 12/31/1993 | |
| ODAN-ATROPINE | odan laboratories ltd | 00622907 | Drops - Ophthalmic | 1 % | 12/31/1991 |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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