Application Nr Approved Date Route Status External Links
NDA021416 2003-09-04 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Propafenone Hydrochloride Extended-Release (sr) 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. Usage Considerations: •the Use Of Propafenone Hydrochloride Extended-Release (sr) 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 (sr) 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]. Propafenone Hydrochloride Extended-Release (sr) 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 (sr) Capsules With Drugs That Increase The Atrioventricular Nodal Refractory Period. (1) •the Effect Of Propafenone On Mortality Has Not Been Determined. (1)

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Antifoam ANTIFOAM Unresolved
2. Gelatin GELATIN Unresolved
3. Hypromelloses HYPROMELLOSES Unresolved
4. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
5. Ferric Oxide Red FERRIC OXIDE RED Molecular
6. Shellac SHELLAC Unresolved
7. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
8. Lecithin, Soybean LECITHIN, SOYBEAN Unresolved

Active Ingredients ( 1 Total)

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

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