Overview
A class I anti-arrhythmic agent (one that interferes directly with the depolarization of the cardiac membrane and thus serves as a membrane-stabilizing agent) with a depressant action on the heart similar to that of guanidine. It also possesses some anticholinergic and local anesthetic properties.
Background
A class I anti-arrhythmic agent (one that interferes directly with the depolarization of the cardiac membrane and thus serves as a membrane-stabilizing agent) with a depressant action on the heart similar to that of guanidine. It also possesses some anticholinergic and local anesthetic properties.
Indication
For the treatment of documented ventricular arrhythmias, such as sustained ventricular tachycardia, ventricular pre-excitation and cardiac dysrhythmias. It is a Class Ia antiarrhythmic drug.
Associated Conditions
- Ventricular Arrhythmia
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2014/11/19 | Not Applicable | UNKNOWN | |||
1999/10/28 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Teva Pharmaceuticals USA, Inc. | 0093-3127 | ORAL | 100 mg in 1 1 | 4/28/2022 | |
| Greenstone LLC | 59762-0386 | ORAL | 100 mg in 1 1 | 9/12/2023 | |
| Mylan Pharmaceuticals Inc. | 59762-0386 | ORAL | 100 mg in 1 1 | 9/12/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0025-2762 | ORAL | 150 mg in 1 1 | 8/30/2023 | |
| Greenstone LLC | 59762-0400 | ORAL | 150 mg in 1 1 | 9/12/2023 | |
| Mylan Pharmaceuticals Inc. | 59762-0400 | ORAL | 150 mg in 1 1 | 9/12/2023 | |
| Mayne Pharma Commercial LLC | 51862-096 | ORAL | 150 mg in 1 1 | 7/6/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0025-2742 | ORAL | 150 mg in 1 1 | 8/30/2023 | |
| Mayne Pharma Commercial LLC | 51862-095 | ORAL | 100 mg in 1 1 | 7/6/2023 | |
| Pfizer Laboratories Div Pfizer Inc | 0025-2732 | ORAL | 100 mg in 1 1 | 8/30/2023 |
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 |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| Disopyramide phosphate Tablets | 国药准字H50020142 | 化学药品 | 片剂 | 8/24/2020 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| RYTHMODAN disopyramide 150 mg capsule blister pack | 13538 | Medicine | A | 8/30/1991 | |
| RYTHMODAN disopyramide 100 mg capsule blister pack | 13537 | Medicine | A | 8/30/1991 | |
| Norpace Retard 150mg Tablets | 32754 | Proqualix Pty Ltd - in Administration | Medicine | A | 10/28/1991 |