Atropine
Atropen, Duodote, Enlon, Lomotil, Motofen (atropine) is a small molecule pharmaceutical. Atropine was first approved as Atropen on 1982-01-01. It is used to treat bradycardia, heart arrest, poisoning, sinoatrial block, and stomach ulcer amongst others in the USA. The pharmaceutical is active against muscarinic acetylcholine receptor M3, muscarinic acetylcholine receptor M2, muscarinic acetylcholine receptor M1, muscarinic acetylcholine receptor M5, and muscarinic acetylcholine receptor M4. In addition, it is known to target alpha-2A adrenergic receptor.
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Commercial
Trade Name
FDA
EMA
Combinations
Duodote, Lomotil, Motofen (generic drugs available since 1982-01-01, discontinued: Atnaa, Colonaid, Di-atro, Enlon, Lo-trol, Logen, Lomanate, Lonox, Low-quel)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Atropine
Atropine
+
Pralidoxime chloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| DUODOTE | Meridian Medical Technologies | N-021983 RX | 2006-09-28 | 1 products, RLD, RS |
Show 1 discontinued
Atropine sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ATROPINE SULFATE | ACCORD HLTHCARE | N-214652 RX | 2020-09-29 | 2 products, RLD, RS |
| ATROPINE SULFATE | Akorn | N-206289 RX | 2014-07-18 | 1 products, RLD, RS |
| ISOPTO ATROPINE | Alcon Research | N-208151 RX | 2016-12-01 | 1 products, RLD, RS |
| ATROPINE SULFATE | Bausch Health Companies | N-213581 RX | 2022-03-15 | 1 products, RLD, RS |
| ATROPINE SULFATE | Fresenius Kabi | N-209260 RX | 2018-01-26 | 1 products, RLD, RS |
| ATROPINE SULFATE | Hospira | N-021146 RX | 2001-07-09 | 3 products, RLD, RS |
Show 1 discontinued
Atropine sulfate
+
Difenoxin hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MOTOFEN | Sebela Pharmaceuticals | N-017744 RX | 1982-01-01 | 1 products, RLD, RS |
Show 1 discontinued
Atropine sulfate
+
Diphenoxylate hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LOMOTIL | Mylan | N-012462 RX | 1982-01-01 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| atnaa atropine and pralidoxime chloride | New Drug Application | 2021-11-26 |
| atropen auto-injector | New Drug Application | 2020-11-30 |
| atropine sulfate | ANDA | 2023-06-16 |
| duodote | New Drug Application | 2021-12-03 |
| enlon | 2006-10-17 | |
| lomotil | New Drug Application | 2022-04-01 |
| motofen | New Drug Application | 2018-12-14 |
| sore throat logenzes | OTC monograph not final | 2021-11-10 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| bradycardia | HP_0001662 | D001919 | R00.1 |
| heart arrest | EFO_0009492 | D006323 | I46 |
| poisoning | EFO_0008546 | D011041 | T65.91 |
| sinoatrial block | — | D012848 | I45.5 |
| stomach ulcer | — | D013276 | K25 |
| uveitis | EFO_1001231 | D014605 | H20.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ATROPINE SULFATE, ATROPINE SULFATE, AM REGENT | |||
| 2023-01-29 | CGT | ||
Patent Expiration
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A03: Drugs for functional gastrointestinal disorders
— A03B: Belladonna and derivatives containing drugs, plain for functional gastrointestinal disorders
— A03BA: Belladonna alkaloids, tertiary amines for functional gastrointestinal disorders
— A03BA01: Atropine
— A03C: Antispasmodics in combination with psycholeptics
— A03CB: Belladonna and derivatives in combination with psycholeptics
— A03CB03: Atropine and psycholeptics
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01F: Mydriatics and cycloplegics
— S01FA: Anticholinergic mydriatics and cycloplegics
— S01FA01: Atropine
Clinical
Clinical Trials
151 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Myopia | D009216 | H52.1 | 7 | 5 | 8 | 7 | 11 | 35 | |
| Amblyopia | D000550 | H53.00 | — | — | 7 | 1 | 1 | 9 | |
| Bradycardia | D001919 | HP_0001662 | R00.1 | — | 1 | — | 5 | — | 6 |
| Spinal anesthesia | D000775 | — | — | — | 3 | 2 | 5 | ||
| Neuromuscular blockade | D019148 | — | — | 1 | 4 | — | 5 | ||
| Postoperative nausea and vomiting | D020250 | EFO_0004888 | — | — | — | 1 | 2 | 3 | |
| Hypotension | D007022 | EFO_0005251 | I95 | — | — | — | 1 | 2 | 3 |
| Intratracheal intubation | D007442 | — | 2 | 2 | 1 | — | 3 | ||
| Drug-related side effects and adverse reactions | D064420 | T88.7 | — | — | — | 2 | 1 | 3 | |
| Post-dural puncture headache | D051299 | — | 1 | 1 | 1 | — | 3 |
Show 18 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Degenerative myopia | D047728 | H44.2 | 2 | 2 | 2 | — | 2 | 6 | |
| Anesthesia | D000758 | — | — | 2 | — | 1 | 3 | ||
| Premedication | D011292 | — | 2 | 2 | — | — | 2 | ||
| Organophosphate poisoning | D062025 | 1 | 1 | 1 | — | — | 2 | ||
| Hypospadias | D007021 | EFO_0004209 | Q54 | — | 1 | 1 | — | — | 1 |
| Replacement arthroplasty knee | D019645 | — | — | 1 | — | — | 1 | ||
| Replacement arthroplasty hip | D019644 | — | — | 1 | — | — | 1 | ||
| Blood coagulation | D001777 | GO_0007596 | — | — | 1 | — | — | 1 | |
| General anesthesia | D000768 | — | — | 1 | — | — | 1 | ||
| Lymphoma | D008223 | C85.9 | — | — | 1 | — | — | 1 |
Show 3 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | — | — | — | 2 |
| Heart arrest | D006323 | EFO_0009492 | I46 | — | 1 | — | — | 1 | 2 |
| Amyotrophic lateral sclerosis | D000690 | EFO_0000253 | G12.21 | — | 1 | — | — | — | 1 |
| Allergic rhinitis seasonal | D006255 | EFO_0003956 | J30 | — | 1 | — | — | — | 1 |
| Regional blood flow | D012039 | — | 1 | — | — | — | 1 | ||
| Ocular physiological phenomena | D009799 | — | 1 | — | — | — | 1 | ||
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 1 | — | — | — | 2 | 3 | ||
| Hypoglycemia | D007003 | HP_0001943 | E16.2 | 2 | — | — | — | — | 2 |
| Sialorrhea | D012798 | HP_0002307 | K11.7 | 1 | — | — | — | 1 | 2 |
| Digestive system physiological phenomena | D004068 | 1 | — | — | — | — | 1 | ||
| Gastrointestinal motility | D005769 | 1 | — | — | — | — | 1 | ||
| Gastric bypass | D015390 | EFO_0005244 | 1 | — | — | — | — | 1 | |
| Insulin resistance | D007333 | EFO_0002614 | 1 | — | — | — | — | 1 | |
| Vasodilation | D014664 | 1 | — | — | — | — | 1 | ||
| Vasoconstriction | D014661 | 1 | — | — | — | — | 1 | ||
| Autonomic nervous system diseases | D001342 | EFO_0009532 | G90 | 1 | — | — | — | — | 1 |
Show 3 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary bladder neoplasms | D001749 | C67 | — | — | — | — | 1 | 1 | |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | — | — | 1 | 1 |
| Sudden death cardiac | D016757 | EFO_0004278 | — | — | — | — | 1 | 1 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | 1 | 1 | ||
| Fissure in ano | D005401 | HP_0012390 | K60.2 | — | — | — | — | 1 | 1 |
| Hemorrhoids | D006484 | EFO_0009552 | K64 | — | — | — | — | 1 | 1 |
| Death | D003643 | PATO_0001422 | — | — | — | — | 1 | 1 | |
| Noise | D009622 | — | — | — | — | 1 | 1 |
Show 3 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ATROPINE |
| INN | edrophonium chloride |
| Description | Atropine is a racemate composed of equimolar concentrations of (S)- and (R)-atropine. It is obtained from deadly nightshade (Atropa belladonna) and other plants of the family Solanaceae. It has a role as a muscarinic antagonist, an anaesthesia adjuvant, an anti-arrhythmia drug, a mydriatic agent, a parasympatholytic, a bronchodilator agent, a plant metabolite, an antidote to sarin poisoning and a oneirogen. It contains a (S)-atropine and a (R)-atropine. |
| Classification | Small molecule |
| Drug class | atropine derivatives |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CN1[C@H]2CC[C@@H]1C[C@H](OC(=O)C(CO)c1ccccc1)C2 |
Identifiers
| PDB | — |
| CAS-ID | 51-55-8 |
| RxCUI | 1223 |
| ChEMBL ID | CHEMBL517712 |
| ChEBI ID | 16684 |
| PubChem CID | 174174 |
| DrugBank | DB00572 |
| UNII ID | QO611KSM5P (ChemIDplus, GSRS) |
Target
Agency Approved
CHRM3
CHRM3
CHRM2
CHRM2
CHRM1
CHRM1
CHRM5
CHRM5
CHRM4
CHRM4
Alternate
ADRA2A
ADRA2A
Organism
Homo sapiens
Gene name
ADRA2A
Gene synonyms
ADRA2R, ADRAR
NCBI Gene ID
Protein name
alpha-2A adrenergic receptor
Protein synonyms
adrenergic, alpha-2A-, receptor, Alpha-2 adrenergic receptor subtype C10, alpha-2-adrenergic receptor, platelet type, Alpha-2A adrenoceptor, Alpha-2A adrenoreceptor, Alpha-2AAR, alpha-2AAR subtype C10
Uniprot ID
Mouse ortholog
Adra2a (11551)
alpha-2A adrenergic receptor (Q3URE6)
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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85,025 adverse events reported
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