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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
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 | |||
2024/04/15 | Phase 1 | Completed | Biomedical Advanced Research and Development Authority | ||
2024/04/11 | Not Applicable | 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 |
|---|---|---|---|---|---|
| Atropine Sulfate Injection | 国药准字H42021161 | 化学药品 | 注射剂 | 7/13/2020 | |
| Atropine Sulfate Injection | 国药准字H41020120 | 化学药品 | 注射剂 | 9/4/2020 | |
| Atropine Sulfate Injection | 国药准字H42022999 | 化学药品 | 注射剂 | 9/10/2020 | |
| Atropine Sulfate Injection | 国药准字H32021824 | 化学药品 | 注射剂 | 8/17/2020 | |
| Atropine Sulfate Injection | 国药准字H51020758 | 化学药品 | 注射剂(注射液) | 4/30/2021 | |
| Atropine Sulfate Injection | 国药准字H20053532 | 化学药品 | 注射剂 | 7/17/2022 | |
| Atropine Sulfate Injection | 国药准字H13021450 | 化学药品 | 注射剂 | 11/3/2020 | |
| Atropine Sulfate Injection | 国药准字H32021536 | 化学药品 | 注射剂(注射液) | 9/27/2020 | |
| Atropine Sulfate Injection | 国药准字H44022488 | 化学药品 | 注射剂 | 1/6/2020 | |
| Atropine Sulfate Injection | 国药准字H37020484 | 化学药品 | 注射剂 | 9/11/2023 |
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
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