Disopyramide

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.

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
Catheter Ablation Compared With Pharmacological Therapy for Atrial Fibrillation (CAPTAF Trial)	2014/11/19	NCT02294955	Not Applicable	UNKNOWN	Uppsala University Hospital
Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)	1999/10/28	NCT00000556	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Disopyramide Phosphate	Teva Pharmaceuticals USA, Inc.	0093-3127	ORAL	100 mg in 1 1	4/28/2022
Disopyramide Phosphate	Greenstone LLC	59762-0386	ORAL	100 mg in 1 1	9/12/2023
Disopyramide Phosphate	Mylan Pharmaceuticals Inc.	59762-0386	ORAL	100 mg in 1 1	9/12/2023
Norpace	Pfizer Laboratories Div Pfizer Inc	0025-2762	ORAL	150 mg in 1 1	8/30/2023
Disopyramide Phosphate	Greenstone LLC	59762-0400	ORAL	150 mg in 1 1	9/12/2023
Disopyramide Phosphate	Mylan Pharmaceuticals Inc.	59762-0400	ORAL	150 mg in 1 1	9/12/2023
DISOPYRAMIDE PHOSPHATE	Mayne Pharma Commercial LLC	51862-096	ORAL	150 mg in 1 1	7/6/2023
Norpace CR	Pfizer Laboratories Div Pfizer Inc	0025-2742	ORAL	150 mg in 1 1	8/30/2023
DISOPYRAMIDE PHOSPHATE	Mayne Pharma Commercial LLC	51862-095	ORAL	100 mg in 1 1	7/6/2023
Norpace CR	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
No NMPA approvals found for this drug.

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	Lacuna Pharma Pty Ltd	Medicine	A	8/30/1991
RYTHMODAN disopyramide 100 mg capsule blister pack	13537	Lacuna Pharma Pty Ltd	Medicine	A	8/30/1991
Norpace Retard 150mg Tablets	32754	Proqualix Pty Ltd - in Administration	Medicine	A	10/28/1991

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
RYTHMODAN CAP 100MG	roussel canada inc.	00382876	Capsule - Oral	100 MG	12/31/1977
RYTHMODAN CAPSULES 100MG	hoechst roussel canada inc.	01989553	Capsule - Oral	100 MG	3/3/1997
RYTHMODAN CAP 150MG	roussel canada inc.	00439363	Capsule - Oral	150 MG	12/31/1978
RYTHMODAN	Cheplapharm Arzneimittel Gmbh	02224801	Capsule - Oral	100 MG	9/12/2003
RYTHMODAN CAPSULES 150MG	hoechst roussel canada inc.	01989561	Capsule - Oral	150 MG	5/31/1996
RYTHMODAN	sanofi-aventis canada inc	02224828	Capsule - Oral	150 MG	9/15/2003

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
DICORYNAN 100 mg CAPSULAS DURAS	Cheplapharm Arzneimittel Gmbh	52549	CÁPSULA DURA	Medicamento Sujeto A Prescripción Médica. Tratamiento De Larga Duración	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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