Procainamide

Generic Name: Procainamide

Brand Names: Procan

Drug Type: Small Molecule

Chemical Formula: C_₁₃H_₂₁N_₃O

CAS Number: 51-06-9

Unique Ingredient Identifier: L39WTC366D

Overview

A derivative of procaine with less CNS action.

Indication

For the treatment of life-threatening ventricular arrhythmias.

Associated Conditions

Supraventricular Arrhythmias
Ventricular Tachycardia (VT)
Life-threatening ventricular arrhythmias
Pre-excited atrial fibrillation

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
RAFF4 Trial: Vernakalant vs. Procainamide for Acute Atrial Fibrillation in the Emergency Department	2020/07/24	NCT04485195	Phase 4	Completed	Ottawa Hospital Research Institute
Prevention of Post-Operative Cardiac Arrhythmias	2020/01/21	NCT04234906	Phase 4	UNKNOWN	Jeffrey Moak
Acute Mechanical Response to Anti-arrhythmic Drug Therapy	2015/10/14	NCT02575534	Not Applicable	Withdrawn	Evan Adelstein, MD
ST-segment Elevation as an AF Endophenotype	2010/09/20	NCT01205529	Not Applicable	Completed	Vanderbilt University Medical Center
Ajmaline Utilization in the Diagnosis and Treatment of Cardiac Arrhythmias	2008/06/20	NCT00702117	Phase 4	Completed	Hospital Clinic of Barcelona
Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE)	1999/10/28	NCT00000464	Phase 3	Completed	University of Washington
Atrial Fibrillation Follow-up Investigation of Rhythm Management (AFFIRM)	1999/10/28	NCT00000556	Phase 3	Completed	National Heart, Lung, and Blood Institute (NHLBI)
Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM)	1999/10/28	NCT00000518	Phase 3	Completed	University of Utah

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Procainamide Hydrochloride	Hospira, Inc.	0409-1903	INTRAMUSCULAR, INTRAVENOUS	500 mg in 1 mL	6/28/2023
Procainamide Hydrochloride	Nexus Pharmaceuticals LLC	14789-901	INTRAVENOUS, INTRAMUSCULAR	100 mg in 1 mL	11/10/2023
PROCAINAMIDE HCI	HF Acquisition Co LLC, DBA HealthFirst	51662-1334	INTRAMUSCULAR, INTRAVENOUS	100 mg in 1 mL	2/19/2024
PROCAINAMIDE HYDROCHLORIDE	HF Acquisition Co LLC, DBA HealthFirst	51662-1630	INTRAVENOUS, INTRAMUSCULAR	100 mg in 1 mL	1/22/2024
Procainamide Hydrochloride	Hospira, Inc.	0409-1902	INTRAMUSCULAR, INTRAVENOUS	100 mg in 1 mL	6/28/2023
PROCAINAMIDE HCI	HF Acquisition Co LLC, DBA HealthFirst	51662-1392	INTRAMUSCULAR, INTRAVENOUS	500 mg in 1 mL	4/24/2023
Procainamide Hydrochloride	Medical Purchasing Solutions, LLC	71872-7113	INTRAVENOUS, INTRAMUSCULAR	100 mg in 1 mL	11/21/2023
Procainamide Hydrochloride	Nexus Pharmaceuticals LLC	14789-900	INTRAVENOUS, INTRAMUSCULAR	500 mg in 1 mL	11/10/2023

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
No TGA approvals found for this drug.

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
APO-PROCAINAMIDE CAP 250MG	Apotex Inc	00713325	Capsule - Oral	250 MG	12/31/1986
PROCAINAMIDE HYDROCHLORIDE INJECTION USP	Sandoz Canada, Inc.	02184486	Solution - Intravenous , Intramuscular	100 MG / ML	12/31/1995
PROCAINAMIDE-250 CAP 250MG	PRO DOC LIMITEE	00731382	Capsule - Oral	250 MG	12/31/1987
PROCAN SR	erfa canada 2012 inc	00638676	Tablet (Extended-Release) - Oral	500 MG	12/31/1985
APO-PROCAINAMIDE CAP 500MG	Apotex Inc	00713341	Capsule - Oral	500 MG	12/31/1986
PRONESTYL CAP 250MG	squibb canada inc., division of bristol-myers squibb canada inc.	00029076	Capsule - Oral	250 MG	12/31/1955
PRONESTYL INJ 100MG/ML	squibb canada inc., division of bristol-myers squibb canada inc.	00029181	Liquid - Intravenous , Intramuscular	100 MG / ML	12/31/1955
PRONESTYL-SR TAB 500MG	squibb canada inc., division of bristol-myers squibb canada inc.	00639885	Tablet (Extended-Release) - Oral	500 MG	12/31/1984
PROCAN SR	erfa canada 2012 inc	00638684	Tablet (Extended-Release) - Oral	750 MG	12/31/1985
PRONESTYL CAP 375MG	squibb canada inc., division of bristol-myers squibb canada inc.	00296031	Capsule - Oral	375 MG	12/31/1973

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

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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