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About Propafenone

Propafenone is a medication prescribed to help manage certain irregular heart rhythms, known as arrhythmias. If you've been prescribed propafenone, understanding how it works and how to manage its cost is key. TheDrugClub is here to help you navigate your prescription needs, offering significant savings on essential medications like propafenone.

The information above is for educational purposes only and does not constitute medical advice. Consult your healthcare provider before making medication decisions.

What Propafenone is approved for (FDA label)

Propafenone hydrochloride extended-release capsules is 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.

Source: Read the full FDA label on DailyMed. Label effective date: December 26, 2024.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Boxed warning for Propafenone (FDA label)

WARNING: MORTALITY •In the National Heart, Lung, and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind trial in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than 6 days but less than 2 years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in patients treated with encainide or flecainide (Class IC antiarrhythmics) compared with that seen in patients assigned to placebo (3%; 22/725). The average duration of treatment with encainide or flecainide in this trial was 10 months.•The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) or other antiarrhythmic drugs is uncertain, but at present, it is prudent to consider any IC antiarrhythmic to have a significant proarrhythmic risk in patients with structural heart disease. Given the lack of any evidence that these drugs improve survival, antiarrhythmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs. WARNING: MORTALITY See full prescribing information for complete boxed warning •An increased rate of death or reversed cardiac arrest rate was seen in patients treated with encainide or flecainide (Class IC antiarrhythmics) compared with that seen in patients assigned to placebo.

Source: FDA prescribing information (DailyMed). Set ID: bc1d2548-15a3-4986-92b1-c3ddfb35343a. SPL document ID: 827a5fb5-9318-4116-9e23-6b75e469dd77. Label effective date: December 26, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Dosage forms and strengths for Propafenone (FDA label)

Propafenone hydrochloride extended-release capsules are supplied as hard gelatin capsules containing either 225 mg, 325 mg, or 425 mg of propafenone HCl. The 225-mg strength is brown opaque cap, white opaque body, with "225" imprinted in light blue ink on the body, content is round, white or off-white tablet. The 325-mg strength is light coral opaque cap, white opaque body, with "325" imprinted in light blue ink on the body, content is round, white or off-white tablet. The 425-mg strength is white opaque cap, white opaque body, with "425" imprinted in light blue ink on the body, content is round, white or off-white tablet. Capsules: 225 mg, 325 mg, 425 mg. (3)

Source: FDA prescribing information (DailyMed). Set ID: bc1d2548-15a3-4986-92b1-c3ddfb35343a. SPL document ID: 827a5fb5-9318-4116-9e23-6b75e469dd77. Label effective date: December 26, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Adverse reactions for Propafenone (FDA label)

The most commonly reported adverse events with propafenone (greater than 5% and greater than placebo) excluding those not reasonably associated with the use of the drug included the following: dizziness, palpitations, chest pain, dyspnea, taste disturbance, nausea, fatigue, anxiety, constipation, upper respiratory tract infection, edema, and influenza. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Vitruvias Therapeutics at 1-844-451-5944 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Source: FDA prescribing information (DailyMed). Set ID: bc1d2548-15a3-4986-92b1-c3ddfb35343a. SPL document ID: 827a5fb5-9318-4116-9e23-6b75e469dd77. Label effective date: December 26, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Contraindications for Propafenone (FDA label)

Propafenone hydrochloride extended-release capsules is contraindicated in the following circumstances: Heart failure Cardiogenic shock Sinoatrial, atrioventricular, and intraventricular disorders of impulse generation or conduction (e.g., sick sinus node syndrome, AV block) in the absence of an artificial pacemaker Known Brugada Syndrome Bradycardia Marked hypotension Bronchospastic disorders or severe obstructive pulmonary disease Marked electrolyte imbalance Heart failure (4) Cardiogenic shock (4) Sinoatrial, atrioventricular, and intraventricular disorders of impulse generation and/or conduction in the absence of pacemaker (4) Known Brugada Syndrome (4) Bradycardia (4) Marked hypotension (4) Bronchospastic disorders and severe obstructive pulmonary disease (4) Marked electrolyte imbalance (4)

Source: FDA prescribing information (DailyMed). Set ID: bc1d2548-15a3-4986-92b1-c3ddfb35343a. SPL document ID: 827a5fb5-9318-4116-9e23-6b75e469dd77. Label effective date: December 26, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Warnings and precautions for Propafenone (FDA label)

May cause new or worsened arrhythmias. Evaluate patients via ECG prior to and during therapy. (5.1) Propafenone hydrochloride extended-release capsules may unmask Brugada or Brugada-like Syndrome. Evaluate patients via ECG after initiation of therapy. (4, 5.2) Avoid use with other antiarrhythmic agents or drugs that prolong the QT interval. (5.3) Avoid simultaneous use of propafenone with both a cytochrome P450 2D6 (CYP2D6) inhibitor and a 3A4 inhibitor (CYP3A4). (5.4) May provoke overt heart failure. (5.5) May cause dose-related first-degree AV block or other conduction disturbances. Should not be given to patients with conduction defects in absence of a pacemaker. (5.6) May affect artificial pacemakers.

Source: FDA prescribing information (DailyMed). Set ID: bc1d2548-15a3-4986-92b1-c3ddfb35343a. SPL document ID: 827a5fb5-9318-4116-9e23-6b75e469dd77. Label effective date: December 26, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.

Drug interactions for Propafenone (FDA label)

Inhibitors of CYP2D6, 1A2, and 3A4 may increase propafenone levels which may lead to cardiac arrhythmias. Simultaneous use with both a CYP3A4 and CYP2D6 inhibitor (or in patients with CYP2D6 deficiency) should be avoided. (7.1) Propafenone may increase digoxin or warfarin levels. (7.2, 7.3) Orlistat may reduce propafenone concentrations. Abrupt cessation of orlistat in patients stable on propafenone hydrochloride extended-release capsules has resulted in convulsions, atrioventricular block, and circulatory failure. (7.4) Concomitant use of lidocaine may increase central nervous system side effects. (7.6) 7.1 CYP2D6 and CYP3A4 Inhibitors Drugs that inhibit CYP2D6 (such as desipramine, paroxetine, ritonavir, sertraline) and CYP3A4 (such as ketoconazole, ritonavir, saquinavir, erythromycin, grapefruit juice) can be expected to cause increased plasma levels of propafenone. The combination of CYP3A4 inhibition and either CYP2D6 deficiency or CYP2D6 inhibition with administration of propafenone may increase the risk of adverse reactions, including proarrhythmia.

Source: FDA prescribing information (DailyMed). Set ID: bc1d2548-15a3-4986-92b1-c3ddfb35343a. SPL document ID: 827a5fb5-9318-4116-9e23-6b75e469dd77. Label effective date: December 26, 2024. Read the full label.

Excerpt from the FDA-approved prescribing information. This is not medical advice; talk to your doctor or pharmacist.