Procainamide
Procainamide (procainamide) is a small molecule pharmaceutical. Procainamide was first approved as Pronestyl on 1982-01-01. It is used to treat atrial fibrillation, atrial flutter, cardiac arrhythmias, supraventricular tachycardia, and ventricular premature complexes amongst others in the USA.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| cardiovascular diseases | D002318 |
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Procainamide (discontinued: Procainamide, Procan, Procanbid, Procapan, Pronestyl, Pronestyl-sr)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Procainamide hydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PRONESTYL | Bristol Myers Squibb | N-007335 DISCN | 1982-01-01 | 5 products, RLD |
| PRONESTYL | Bristol Myers Squibb | N-017371 DISCN | 1982-01-01 | 3 products |
| PROCANBID | King Pharmaceuticals | N-020545 DISCN | 1996-01-31 | 2 products |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| procainamide hci | ANDA | 2024-02-19 |
| procainamide hydrochloride | ANDA | 2024-10-10 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| J2690 | Injection, procainamide hcl, up to 1 gm |
Clinical
Clinical Trials
22 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiac arrhythmias | D001145 | EFO_0004269 | I49.9 | — | — | 3 | 3 | 1 | 7 |
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | — | 3 | 2 | 2 | 7 |
| Tachycardia | D013610 | HP_0001649 | R00.0 | — | — | 1 | 3 | 1 | 5 |
| Ventricular tachycardia | D017180 | — | I47.2 | — | — | 1 | 3 | — | 4 |
| Malaria | D008288 | EFO_0001068 | B54 | — | 1 | 1 | 1 | — | 3 |
| Fetal growth retardation | D005317 | EFO_0000495 | — | — | — | — | 1 | — | 1 |
| Cardiac surgical procedures | D006348 | — | — | — | — | — | 1 | — | 1 |
| Emergencies | D004630 | — | — | — | — | — | 1 | — | 1 |
| Brugada syndrome | D053840 | Orphanet_130 | I49.8 | — | — | — | 1 | — | 1 |
| Chronic renal insufficiency | D051436 | — | N18 | — | — | — | 1 | — | 1 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | 3 | — | — | 3 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 3 | — | — | 3 |
| Ventricular fibrillation | D014693 | HP_0001663 | I49.01 | — | — | 2 | — | — | 2 |
| Healthy volunteers/patients | — | — | — | — | 1 | 1 | — | — | 1 |
| Heart failure | D006333 | HP_0001635 | I50 | — | — | 1 | — | — | 1 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | — | 1 | — | — | 1 |
| Heart arrest | D006323 | EFO_0009492 | I46 | — | — | 1 | — | — | 1 |
| Infarction | D007238 | EFO_0009463 | — | — | — | 1 | — | — | 1 |
| Sudden death cardiac | D016757 | EFO_0004278 | — | — | — | 1 | — | — | 1 |
| Sudden death | D003645 | HP_0001699 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiotoxicity | D066126 | EFO_1001482 | — | — | 1 | — | — | — | 1 |
| Parasitemia | D018512 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | — | — | — | — | 1 | 1 |
| Supraventricular tachycardia | D013617 | HP_0004755 | I47.1 | — | — | — | — | 1 | 1 |
| Atrial flutter | D001282 | EFO_0003911 | — | — | — | — | — | 1 | 1 |
| Electroacupuncture | D015671 | — | — | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | — | 1 | 1 |
| Psychogenic polydipsia | D059607 | — | — | — | — | — | — | 1 | 1 |
| Diabetes insipidus | D003919 | — | E23.2 | — | — | — | — | 1 | 1 |
| Neurogenic diabetes insipidus | D020790 | HP_0000863 | — | — | — | — | — | 1 | 1 |
| Nephrogenic diabetes insipidus | D018500 | — | N25.1 | — | — | — | — | 1 | 1 |
| Polyuria | D011141 | HP_0000103 | R35 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Procainamide |
| INN | procainamide |
| Description | Procainamide is a benzamide that is 4-aminobenzamide substituted on the amide N by a 2-(diethylamino)ethyl group. It is a pharmaceutical antiarrhythmic agent used for the medical treatment of cardiac arrhythmias. It has a role as a sodium channel blocker, an anti-arrhythmia drug and a platelet aggregation inhibitor. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCN(CC)CCNC(=O)c1ccc(N)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 51-06-9 |
| RxCUI | — |
| ChEMBL ID | CHEMBL640 |
| ChEBI ID | 8428 |
| PubChem CID | 4913 |
| DrugBank | DB01035 |
| UNII ID | L39WTC366D (ChemIDplus, GSRS) |
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Procainamide
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Procainamide hci, Procainamide hydrochloride
Adverse Events
Top Adverse Reactions
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241 adverse events reported
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