Atropine
- Generic Name
- Atropine
- Brand Names
- Atnaa, Atropen, Busulfex, Donnatal, Duodote, Enlon-plus, Isopto Atropine, Lomotil, Minims Atropine Sulphate, Motofen, Phenohytro
- Drug Type
- Small Molecule
- Chemical Formula
- C17H23NO3
- CAS Number
- 51-55-8
- Unique Ingredient Identifier
- 7C0697DR9I
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.
Background
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2015/05/15 | Phase 4 | Completed | |||
2015/02/11 | Phase 4 | Completed | Enrique Alday Muñoz | ||
2014/12/31 | Phase 4 | Completed | |||
2014/08/29 | Not Applicable | UNKNOWN | |||
2014/07/10 | Phase 4 | Completed | |||
2014/05/05 | Not Applicable | Completed | Chang Gung Memorial Hospital | ||
2014/03/10 | Phase 2 | UNKNOWN | |||
2014/02/05 | Not Applicable | Completed | |||
2013/09/27 | Phase 1 | Completed | |||
2013/08/16 | Phase 2 | UNKNOWN |
FDA Approved Products
Product Name | Manufacturer | Route | Strength | Approved | NDC Code |
|---|---|---|---|---|---|
Atropine Sulfate | Medical Purchasing Solutions, LLC | INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | 1 mg in 1 mL | 2023/05/23 | 71872-7100 |
Donnatal | PBM Pharmaceuticals Inc. | ORAL | 0.0194 mg in 5 mL | 2013/12/03 | 66213-422 |
Diphenoxylate Hydrochloride and Atropine Sulfate | A-S Medication Solutions | ORAL | 0.025 mg in 1 1 | 2018/09/28 | 50090-2641 |
Atropine | A-S Medication Solutions | OPHTHALMIC | 10 mg in 1 mL | 2022/05/02 | 50090-6295 |
Diphenoxylate Hydrochloride and Atropine Sulfate | RedPharm Drug, Inc. | ORAL | .025 mg in 1 1 | 2011/05/23 | 67296-0505 |
Atropine Sulfate | Hospira, Inc. | INTRAVENOUS | 0.1 mg in 1 mL | 2020/06/30 | 0409-1630 |
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE | Direct Rx | ORAL | 0.025 mg in 1 1 | 2023/03/03 | 72189-336 |
Diphenoxylate Hydrochloride and Atropine Sulfate | A-S Medication Solutions | ORAL | 0.025 mg in 1 1 | 2020/02/25 | 50090-5592 |
QUADRAPAX | Rebel Distributors Corp | ORAL | 0.0194 mg in 5 mL | 2011/05/19 | 21695-970 |
ATROPINE SULFATE | Accord Healthcare Inc. | INTRAVENOUS | 1 mg in 1 mL | 2023/03/16 | 16729-526 |
EMA Approved Products
Medicine Name | EMA Number | Auth. Holder | Country | Drug Type | Status | Issued | Opinion | Revision |
|---|
No EMA products found
No EMA products found for this drug
Singapore Approved Products
Product Name | Manufacturer | Dosage Form | Strength | Approved | Approval No. | Online |
|---|
No Singapore products found
No Singapore products found for this drug
China Approved Products
Product Name | Approval No. | Manufacturer | Dosage Form | Trade Name | Strength | Type | Status | Date | Import |
|---|---|---|---|---|---|---|---|---|---|
Atropine Sulfate Injection | 国药准字H42021499 | 华中药业股份有限公司 | 注射剂 | N/A | 1ml:5mg | Chemical Drug | Approved | 2020/09/08 | Domestic |
Atropine Sulfate Injection | 国药准字H44023850 | 广东雷允上药业有限公司 | 注射剂 | N/A | 1ml:0.5mg | Chemical Drug | Approved | 2021/11/04 | Domestic |
Atropine Sulfate Injection | 国药准字H32020166 | 江苏涟水制药有限公司 | 注射剂 | N/A | 1ml:0.5mg | Chemical Drug | Approved | 2020/07/28 | Domestic |
Atropine Sulfate Injection | 国药准字H41021848 | 河南同源制药有限公司 | 注射剂 | N/A | 1ml:5mg | Chemical Drug | Approved | 2020/09/11 | Domestic |
Atropine Sulfate Injection | 国药准字H41024307 | 裕松源药业有限公司 | 注射剂 | N/A | 1ml:0.5mg | Chemical Drug | Approved | 2020/06/17 | Domestic |
Atropine Sulfate Injection | 国药准字H42021500 | 华中药业股份有限公司 | 注射剂 | N/A | 1ml:0.5mg | Chemical Drug | Approved | 2020/09/08 | Domestic |
Atropine Sulfate Injection | 国药准字H42020679 | 武汉滨湖双鹤药业有限责任公司 | 注射剂 | N/A | 2ml：1mg | Chemical Drug | Approved | 2023/01/03 | Domestic |
Atropine Sulfate Injection | 国药准字H37022051 | 瑞阳制药股份有限公司 | 注射剂 | N/A | 1ml:0．5mg | Chemical Drug | Approved | 2020/04/08 | Domestic |
Atropine Sulfate Injection | 国药准字H34020507 | 安徽城市药业股份有限公司 | 注射剂 | N/A | 1ml:0.5mg | Chemical Drug | Approved | 2021/01/07 | Domestic |
Atropine Sulfate Injection | 国药准字H33020792 | 宁波大红鹰药业股份有限公司 | 注射剂 | N/A | 1ml:0.5mg | Chemical Drug | Approved | 2020/06/08 | Domestic |
Australia Approved Products
Product Name | ARTG ID | Sponsor | Status | Reg. Date | Ingredient |
|---|
No Australia products found
No Australia products found for this drug