Application Nr Approved Date Route Status External Links
ANDA205956 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Propafenone Hydrochloride Extended-Release Capsules Are Indicated To Prolong The Time To Recurrence Of Symptomatic Atrial Fibrillation (Af) In Patients With Episodic (Most Likely Paroxysmal Or Persistent) Af Who Do Not Have Structural Heart Disease. Propafenone Hydrochloride Extended-Release Capsules Are An Antiarrhythmic Indicated To Prolong The Time To Recurrence Of Symptomatic Atrial Fibrillation (Af) In Patients With Episodic (Most Likely Paroxysmal Or Persistent) Af Who Do Not Have Structural Heart Disease. ( 1 ) Usage Considerations: Use In Patients With Permanent Atrial Fibrillation Or With Atrial Flutter Or Paroxysmal Supraventricular Tachycardia (Psvt) Has Not Been Evaluated. Do Not Use To Control Ventricular Rate During Atrial Fibrillation. ( 1 ) In Patients With Atrial Fibrillation And Atrial Flutter, Use Propafenone Hydrochloride Extended-Release Capsules With Drugs That Increase The Atrioventricular Nodal Refractory Period. ( 1 ) The Effect Of Propafenone On Mortality Has Not Been Determined. ( 1 ) Usage Considerations: The Use Of Propafenone Hydrochloride Extended-Release Capsules In Patients With Permanent Af Or In Patients Exclusively With Atrial Flutter Or Paroxysmal Supraventricular Tachycardia (Psvt) Has Not Been Evaluated. Do Not Use Propafenone Hydrochloride Extended-Release Capsules To Control Ventricular Rate During Af. Some Patients With Atrial Flutter Treated With Propafenone Have Developed 1:1 Conduction, Producing An Increase In Ventricular Rate. Concomitant Treatment With Drugs That Increase The Functional Atrioventricular (Av) Nodal Refractory Period Is Recommended. The Effect Of Propafenone On Mortality Has Not Been Determined [See Boxed Warning ] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Propafenone Hydrochloride PROPAFENONE HYDROCHLORIDE ZINC1530760

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