DIQTA 1.0: Drug-Induced QT Prolongation Atlas

PROPAFENONE HYDROCHLORIDE

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Most-DIQT concern

Severity Score:4.0

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

WARNINGS AND PRECAUTIONS
Proarrhythmic Effects
Propafenone has caused new or worsened arrhythmias. Such proarrhythmic effects include sudden death and life-threatening ventricular arrhythmias such as ventricular fibrillation, ventricular tachycardia, asystole, and torsade de pointes. It may also worsen premature ventricular contractions or supraventricular arrhythmias, and it may prolong the QT interval. It is therefore essential that each patient given propafenone hydrochloride be evaluated electrocardiographically prior to and during therapy to determine whether the response to propafenone hydrochloride supports continued treatment. Because propafenone prolongs the QRS interval in the electrocardiogram, changes in the QT interval are difficult to interpret [see CLINICAL PHARMACOLOGY (12.2)].
[Use with Drugs that Prolong the QT Interval and Antiarrhythmic Agents]
The use of propafenone hydrochloride in conjunction with other drugs that prolong the QT interval has not been extensively studied. Such drugs may include many antiarrhythmics, some phenothiazines, tricyclic antidepressants, and oral macrolides. Withhold Class IA and III antiarrhythmic agents for at least 5 half-lives prior to dosing with propafenone hydrochloride. Avoid the use of propafenone with Class IA and III antiarrhythmic agents (including quinidine and amiodarone). There is only limited experience with the concomitant use of Class IB or IC antiarrhythmics.
CLINICAL PHARMACOLOGY
Pharmacodynamics
Cardiac Electrophysiology
Electrocardiograms: Propafenone prolongs the PR and QRS intervals. Prolongation of the QRS interval makes it difficult to interpret the effect of propafenone on the QT interval.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

QT Prolongation

24054

Other ADRs

5752

38375835

Odds Ratio = 10.54

Drug Property Information

ATC Code(s):

C01BC03 - propafenone hydrochloride

C01BC - "Antiarrhythmics, class Ic"
C01B - "ANTIARRHYTHMICS, CLASS I AND III"
C01 - CARDIAC THERAPY
C - CARDIOVASCULAR SYSTEM

Active Ingredient:PROPAFENONE HYDROCHLORIDE

Active Ingredient UNII:33XCH0HOCD

Drugbank ID:DB01182

PubChem Compound:4932

CTD ID:D011405

PharmGKB:PA451131

CAS Number:54063-53-5

Dosage Form(s):tablet, film coated

Route(s) Of Administrator:oral

Daily Dose:

300.0 mg/day C01BC03

Chemical Structure:

SMILE Code:
CCCNCC(O)COC1=C(C=CC=C1)C(=O)CCC1=CC=CC=C1

Reference

N/A