Application Nr Approved Date Route Status External Links
ANDA202688 2015-08-24 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 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 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]. 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 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)

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Ferrosoferric Oxide FERROSOFERRIC OXIDE Molecular
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. Potassium Hydroxide POTASSIUM HYDROXIDE Molecular B&N-Buffer & neutralizing agent , MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
7. Shellac SHELLAC Unresolved
8. 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.
9. Talc TALC Unresolved DYE-Dye GRAS-Generally recognized as safe.

Active Ingredients ( 1 Total)

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

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