Application Nr Approved Date Route Status External Links
ANDA075203 2000-10-24 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

Indications And Usage In Patients Without Structural Heart Disease, Propafenone Is Indicated To Prolong The Time To Recurrence Of Paroxysmal Atrial Fibrillation/flutter (paf) Associated With Disabling Symptoms. Paroxysmal Supraventricular Tachycardia (psvt) Associated With Disabling Symptoms. As With Other Agents, 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 Av Refractory Period Is Recommended. The Use Of Propafenone In Patients With Chronic Atrial Fibrillation Has Not Been Evaluated. Propafenone Should Not Be Used To Control Ventricular Rate During Atrial Fibrillation. Propafenone Hydrochloride Tablets Are Also Indicated For The Treatment Of Documented Ventricular Arrhythmias, Such As Sustained Ventricular Tachycardia, That, In The Judgement Of The Physician, Are Life-Threatening. Because Of The Proarrhythmic Effects Of Propafenone, Its Use With Lesser Ventricular Arrhythmias Is Not Recommended, Even If Patients Are Symptomatic, And Any Use Of The Drug Should Be Reserved For Patients In Whom, In The Opinion Of The Physician, The Potential Benefits Outweigh The Risks. Initiation Of Propafenone Treatment, As With Other Antiarrhythmics Used To Treat Life-Threatening Ventricular Arrhythmias, Should Be Carried Out In The Hospital. Antiarrhythmic Drugs Have Not Been Shown To Enhance Survival In Patients With Ventricular Or Atrial Arrhythmias.

All Formulated Excipients (7 Total)

Name Structure Kind Function Status
1. Croscarmellose Sodium CROSCARMELLOSE SODIUM Unresolved
2. Hypromelloses HYPROMELLOSES Unresolved
3. 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.
4. Cellulose, Microcrystalline CELLULOSE, MICROCRYSTALLINE Unresolved
5. Polydextrose POLYDEXTROSE Unresolved MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Polyethylene Glycols POLYETHYLENE GLYCOLS 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.

Active Ingredients ( 1 Total)

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

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