Generic Flecainide

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Flecainide (100 mg): Comprehensive Patient Information for Canada

Basic Product Information

Mechanism of Action

In simple terms: Flecainide is an antiarrhythmic medicine that helps control serious irregular heartbeats. It works by blocking certain electrical signals in the heart that can cause an abnormal rhythm. By stabilizing the heart's electrical activity, it helps restore and maintain a normal, steady heartbeat.

For specialists: Flecainide belongs to the membrane-stabilizing group of antiarrhythmic agents and has electrophysiologic effects characteristic of the Class IC category of the modified Vaughan-Williams classification. It also possesses local anesthetic properties. In single-cell preparations from canine cardiac tissues, flecainide decreased the rate of rise (Vmax, Phase 0) of the action potential without greatly affecting its duration; the duration of the effective refractory period was lengthened and a small change was observed in the slope of Phase 4 depolarization. In man, flecainide produces a dose-related decrease in intracardiac conduction in all parts of the heart, with the greatest effect on the His-Purkinje system (H-V conduction). Effects upon atrioventricular nodal conduction time and intra-atrial conduction times, although present, are less pronounced than those on ventricular conduction velocity. Significant effects on refractory periods were observed only in the ventricle. In patients with accessory AV connections, flecainide has been shown to depress both anterograde and retrograde conduction over the bypass tract.

Pharmacokinetics

• Absorption: Following oral administration, flecainide is nearly completely absorbed, with a bioavailability of 90% to 95%. Peak plasma levels are attained at about 3 hours in most individuals, with a range of 1 to 6 hours. Food and antacids do not affect absorption.
• Metabolism: Flecainide does not undergo any consequential presystemic biotransformation. It is metabolized in the liver, primarily by CYP2D6, to inactive metabolites.
• Elimination: The plasma half-life averages about 20 hours (range 12 to 27 hours) after multiple oral doses in patients with normal renal function. The half-life is moderately longer than in healthy subjects (mean 14 hours). In patients with renal impairment, the plasma half-life is often prolonged and ranges from about 14 to 190 hours. Flecainide elimination is somewhat slower in healthy elderly subjects (t½ = 18 hours) than in young healthy subjects. Flecainide is excreted primarily in the urine, with approximately 30% of the dose excreted unchanged.
• Onset of Action: Antiarrhythmic effects typically begin within a few hours after oral administration. Steady-state plasma levels are reached in approximately 3 to 5 days with twice-daily dosing.
• Duration of Action: The therapeutic effect is maintained with continued twice-daily dosing. The half-life of approximately 20 hours supports twice-daily administration.

Uses in Daily Life and Best Practice Advice

Flecainide is prescribed in Canada for the treatment of serious heart rhythm disorders. Your physician will determine the appropriate use and dose based on your specific medical situation.

• Typical Uses: In patients without structural heart disease and without myocardial infarction, flecainide is indicated for the prevention of paroxysmal supraventricular tachycardias (PSVT) associated with disabling symptoms, including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia, and other supraventricular tachycardias of unspecified mechanism. It is also indicated for the prevention of paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms. For ventricular arrhythmias, it is indicated for documented life-threatening ventricular arrhythmias such as sustained ventricular tachycardia, if they are considered life-threatening in the judgment of the attending physician. It is not indicated for less severe ventricular arrhythmias even if symptomatic.
• Administration: Take the tablet by mouth with or without food as directed by your doctor, usually twice daily. The dosage is based on your age, medical condition, response to treatment, and other medications you may be taking. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.
• Monitoring: Treatment with flecainide should be monitored by frequent ECG recordings and/or plasma level monitoring as recommended. Your physician may recommend that you stay in the hospital for proper monitoring when starting treatment, as flecainide may rarely cause a serious new irregular heartbeat.
• Do Not Stop Without Medical Advice: Do not stop taking this medication without consulting your physician, as this may cause your heart rhythm to become unstable.

Morning vs. Evening Dosing

Flecainide is typically taken twice daily, approximately 12 hours apart. There is no specific clinical recommendation for morning versus evening dosing. Taking it at the same times each day helps maintain consistent blood levels. Always follow the schedule recommended by your physician.

• Twice Daily: The standard dose is taken twice daily, approximately 12 hours apart.
• Consistency: Take flecainide at the same times each day to ensure consistent effects.
• Missed Dose: If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.
• Professional Guidance: Your healthcare provider may adjust the timing based on your response to treatment and other medications.

Administration With or Without Food

Flecainide can be taken with or without food. Food and antacids do not affect the absorption of flecainide. However, dairy products (milk, infant formula) may interfere with the absorption of flecainide in infants and children. This is not a concern for adults taking oral tablets.

• Swallow the tablet whole with a full glass of water.
• Flecainide can be taken with or without food.
• Do not crush or chew the tablet unless directed by your pharmacist. The 100 mg tablet can be divided into equal halves.
• Avoid drinking grapefruit juice while taking flecainide, as it may increase the levels of flecainide in your blood.

Interaction Warnings

Indications for Flecainide

"Off-label" means use outside the official approved indication, usually based on current medical guidelines and scientific evidence.

Dosing According to Clinical Indication

Doses should always be adjusted according to the advice of your physician and depending on your health condition, kidney function, and response to treatment. Flecainide should not be used to treat persistent atrial fibrillation/flutter. Correct electrolyte imbalances before treatment. Perform an adequate clinical assessment to establish that there is no structural heart disease or left ventricular systolic dysfunction.

Side Effects and Safety Profile

Guidelines for Correct Use

• Take flecainide exactly as prescribed by your physician. Do not change your dose without medical advice.
• Swallow the tablet whole with a full glass of water, with or without food, at the same times each day.
• Do not crush or chew the tablet unless directed by your pharmacist. The 100 mg tablet can be divided into equal halves.
• Avoid drinking grapefruit juice while taking flecainide.
• Do not stop taking this medication without consulting your physician.
• Keep all medical appointments for monitoring of your heart rhythm and kidney function.
• Inform every healthcare provider (including dentists, surgeons, and pharmacists) that you are taking flecainide.
• If you are pregnant, planning to become pregnant, or breastfeeding, consult your physician before use.
• If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not double the dose.
• Store at room temperature in a dry place. Keep out of reach of children.

Alternative Treatment Options

• Amiodarone: A Class III antiarrhythmic agent used for a wide range of atrial and ventricular arrhythmias. It is more effective than flecainide for many arrhythmias but has a higher risk of long-term side effects, including thyroid, lung, liver, and eye toxicity.
• Propafenone: Another Class IC antiarrhythmic agent similar to flecainide. It is used for atrial fibrillation and other supraventricular arrhythmias. It also has proarrhythmic potential.
• Sotalol: A Class III antiarrhythmic agent with beta-blocking properties. Used for atrial fibrillation and ventricular arrhythmias. Requires monitoring of QT interval and kidney function.
• Dofetilide: A Class III antiarrhythmic agent used for atrial fibrillation. Requires initiation in a hospital setting due to the risk of QT prolongation.
• Beta-Blockers (e.g., metoprolol, bisoprolol): Used for rate control in atrial fibrillation and for some ventricular arrhythmias. Not as effective as flecainide for rhythm control but have a better safety profile.
• Catheter Ablation: A procedure that uses radiofrequency energy to destroy the abnormal heart tissue causing the arrhythmia. It can be curative for many types of supraventricular tachycardias and atrial fibrillation.

Comparison: Flecainide is distinguished from other antiarrhythmic agents by its potent Class IC sodium channel-blocking properties, which make it highly effective for preventing paroxysmal supraventricular tachycardias and atrial fibrillation in patients without structural heart disease. However, its use is limited by the risk of proarrhythmic effects, particularly in patients with structural heart disease or persistent atrial fibrillation. Amiodarone is more broadly effective but has significant long-term toxicity. Beta-blockers are safer but less effective for rhythm control. Catheter ablation is an increasingly preferred option for many patients with symptomatic arrhythmias. Your physician will determine the best option for your specific condition.

Legal Status, Registration, and Coverage in Canada

• Registration: Flecainide acetate is authorized for sale in Canada by Health Canada as a prescription drug. The brand-name Tambocor is the reference product. Generic formulations are available in 50 mg and 100 mg tablets from manufacturers including Angita Pharma Inc. (AG-Flecainide, DIN 02516071 for 100 mg), Jamp Pharma Corporation (Jamp Flecainide, DIN 02493713 for 100 mg), Apotex Inc. (Apo-Flecainide, DIN 02275546 for 100 mg), Sanis Health Inc. (Flecainide, DIN 02534819 for 100 mg), and Auro Pharma Inc. (Auro-Flecainide).
• Prescription Status: Prescription only in Canada.
• Coverage: Coverage varies by province and territory. In Ontario, Jamp Flecainide 100 mg is listed as an interchangeable product on the Ontario Drug Benefit (ODB) formulary at a drug benefit price of $0.2779 per tablet. In Quebec, AG-Flecainide and other generic formulations are covered under the RAMQ formulary. In Newfoundland and Labrador, Jamp Flecainide 100 mg is listed at $0.3029 per tablet. Generic formulations are generally more affordable than brand-name products.
• Pharmacovigilance: Adverse reactions should be reported to Health Canada's MedEffect Canada program at 1-866-234-2345.

Recent Research and Clinical Guidelines (2022–2026)

• A drug shortage of flecainide 100 mg tablets was reported in Canada in 2025 due to a disruption in the manufacture of the drug. The shortage affected multiple manufacturers and was resolved later in the year.
• Current clinical practice in Canada continues to recommend flecainide for the prevention of paroxysmal supraventricular tachycardias and paroxysmal atrial fibrillation/flutter in patients without structural heart disease and without myocardial infarction.
• Flecainide remains a valuable option for patients with symptomatic paroxysmal atrial fibrillation who do not have structural heart disease. It is often used in a "pill-in-the-pocket" strategy for selected patients, where a single dose is taken at the onset of an arrhythmia episode.
• Research continues to explore the role of flecainide in various clinical settings, including its use in pediatric patients with supraventricular tachycardias and its potential role in the management of catecholaminergic polymorphic ventricular tachycardia (CPVT) in combination with beta-blockers.
• Health Canada has issued safety communications regarding the risk of proarrhythmic effects with flecainide, emphasizing the importance of appropriate patient selection and monitoring during treatment initiation.

Availability and Supply in Canada

Prices and availability may vary by province, territory, and pharmacy. Generic flecainide formulations are widely available in Canada and are generally more affordable than the brand-name product. A drug shortage of flecainide 100 mg tablets was reported in 2025 but has since been resolved. Check with your local pharmacy for current pricing and availability.

Frequently Asked Questions (FAQ)

1. What is flecainide used for?
   Flecainide is used to treat certain types of serious irregular heartbeats, such as paroxysmal supraventricular tachycardia (PSVT) and paroxysmal atrial fibrillation/flutter, in patients without structural heart disease. It is also used for life-threatening ventricular arrhythmias such as sustained ventricular tachycardia.
2. How does flecainide work?
   Flecainide is an antiarrhythmic drug that works by blocking certain electrical signals in the heart that can cause an irregular heartbeat. By stabilizing the heart's electrical activity, it helps restore and maintain a normal, steady heartbeat.
3. What is the correct dose of flecainide 100 mg?
   The usual starting dose for supraventricular arrhythmias is 50 mg every 12 hours, which may be increased in increments of 50 mg twice daily at intervals of at least 4 days. The maximum recommended daily dose is 300 mg for supraventricular arrhythmias. For ventricular arrhythmias, the starting dose is 100 mg every 12 hours, with a maximum of 400 mg per day. Your physician will determine the appropriate dose for your condition.
4. Can I take flecainide with food?
   Yes. Flecainide can be taken with or without food. Food and antacids do not affect the absorption of the medication.
5. What should I do if I miss a dose?
   If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.
6. Can I drink alcohol while taking flecainide?
   Avoid excessive alcohol consumption while taking flecainide, as alcohol may worsen heart conditions.
7. What are the serious side effects of flecainide?
   Serious side effects include proarrhythmic effects (a new or worsening irregular heartbeat, which in rare cases can be deadly), new or worsening heart failure, and severe allergic reactions. Seek immediate medical attention if you experience a faster or more irregular heartbeat, severe dizziness, fainting, or signs of a severe allergic reaction.
8. Is flecainide safe during pregnancy?
   Flecainide should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It crosses the placenta. Consult your physician if you are pregnant or planning to become pregnant.
9. Is flecainide safe during breastfeeding?
   Flecainide passes into breast milk. The relative infant dose is approximately 8%, which is generally considered acceptable (less than 10%). Consult your physician before breastfeeding.
10. Are there alternatives to flecainide?
    Yes. Alternatives include amiodarone, propafenone, sotalol, dofetilide, beta-blockers, and catheter ablation. Your physician will determine the best option for your specific condition.
11. Is flecainide covered by Canadian health insurance?
    Coverage varies by province and territory. In Ontario, Jamp Flecainide is listed on the ODB formulary. In Quebec, AG-Flecainide and other generics are covered under the RAMQ formulary. Check with your provincial drug plan and private insurance provider for coverage details.