pharmacopeia
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Boxed warning

Mortality Flecainide acetate was included in the National Heart Lung and Blood Institute's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, multicenter, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more than six days but less than two years previously. An excessive mortality or non-fatal cardiac arrest rate was seen in patients treated with flecainide acetate compared with that seen in patients assigned to a carefully matched placebo-treated group. This rate was 16/315 (5.1%) for flecainide acetate and 7/309 (2.3%) for the matched placebo. The average duration of treatment with flecainide acetate in this study was ten months. The applicability of the CAST results to other populations (e.g., those without recent myocardial infarction) is uncertain, but at present, it is prudent to consider the risks of Class IC agents (including flecainide acetate), coupled with the lack of any evidence of improved survival, generally unacceptable in patients without life-threatening ventricular arrhythmias, even if the patients are experiencing unpleasant, but not life-threatening, symptoms or signs.

2D structure
N-(piperidin-2-ylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide
SMILES C1CCNC(C1)CNC(=O)C2=C(C=CC(=C2)OCC(F)(F)F)OCC(F)(F)F
InChIKey DJBNUMBKLMJRSA-UHFFFAOYSA-N

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Ion Channel Interactions.

Indications

Sourced from openFDA
  • In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of — paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms — paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of — documented ventricular arrhythmias, such as sustained ventricular tachycardia ( sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital.ICD-10: I48.91

Contraindications

Sourced from openFDA
  • Flecainide acetate tablets are contraindicated in patients with preexisting second- or third-degree AV block, or with right bundle branch block when associated with a left hemiblock (bifascicular block), unless a pacemaker is present to sustain the cardiac rhythm should complete heart block occur. Flecainide acetate tablets are also contraindicated in the presence of cardiogenic shock or known hypersensitivity to the drug.contraindicated

Dosage & administration

Sourced from openFDA

For patients with sustained VT, no matter what their cardiac status, flecainide acetate tablets, like other antiarrhythmics, should be initiated in-hospital with rhythm monitoring. Flecainide has a long half-life (12 to 27 hours in patients). Steady-state plasma levels, in patients with normal renal and hepatic function, may not be achieved until the patient has received 3 to 5 days of therapy at a given dose. Therefore, increases in dosage should be made no more frequently than once every four days, since during the first 2 to 3 days of therapy the optimal effect of a given dose may not be achieved. For patients with PSVT and patients with PAF the recommended starting dose is 50 mg every 12 hours. Flecainide acetate tablets doses may be increased in increments of 50 mg bid every four days until efficacy is achieved. For PAF patients, a substantial increase in efficacy without a substantial increase in discontinuations for adverse experiences may be achieved by increasing the flecainide acetate tablets dose from 50 to 100 mg bid. The maximum recommended dose for patients with paroxysmal supraventricular arrhythmias is 300 mg/day. For sustained VT the recommended starting dose is 100 mg every 12 hours. This dose may be increased in increments of 50 mg bid every four days until efficacy is achieved. Most patients with sustained VT do not require more than 150 mg every 12 hours (300 mg/day) and the maximum dose recommended is 400 mg/day.

Adverse reactions

Sourced from openFDA

In post-myocardial infarction patients with asymptomatic PVCs and non-sustained ventricular tachycardia, flecainide acetate therapy was found to be associated with a 5.1% rate of death and non-fatal cardiac arrest, compared with a 2.3% rate in a matched placebo group. (See WARNINGS .) Adverse effects reported for flecainide acetate, described in detail in the WARNINGS section, were new or worsened arrhythmias which occurred in 1% of 108 patients with PSVT and in 7% of 117 patients with PAF; and new or exacerbated ventricular arrhythmias which occurred in 7% of 1330 patients with PVCs, non-sustained or sustained VT. In patients treated with flecainide for sustained VT, 80% (51/64) of proarrhythmic events occurred within 14 days of the onset of therapy. 198 patients with sustained VT experienced a 13% incidence of new or exacerbated ventricular arrhythmias when dosage was initiated at 200 mg/day with slow upward titration, and did not exceed 300 mg/day in most patients. In some patients, flecainide acetate treatment has been associated with episodes of unresuscitatable VT or ventricular fibrillation (cardiac arrest). (See WARNINGS .) New or worsened CHF occurred in 6.3% of 1046 patients with PVCs, non-sustained or sustained VT. Of 297 patients with sustained VT, 9.1% experienced new or worsened CHF. New or worsened CHF was reported in 0.4% of 225 patients with supraventricular arrhythmias. There have also been instances of second- (0.5%) or third-degree (0.4%) AV block.

Use in specific populations

Sourced from openFDA

Pregnancy Pregnancy Category C . Flecainide has been shown to have teratogenic effects (club paws, sternebrae and vertebrae abnormalities, pale hearts with contracted ventricular septum) and an embryotoxic effect (increased resorptions) in one breed of rabbit (New Zealand White) when given doses of 30 and 35 mg/kg/day, but not in another breed of rabbit (Dutch Belted) when given doses up to 30 mg/kg/day. No teratogenic effects were observed in rats and mice given doses up to 50 and 80 mg/kg/day, respectively; however, delayed sternebral and vertebral ossification was observed at the high dose in rats. Because there are no adequate and well-controlled studies in pregnant women, flecainide acetate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Overdosage

Sourced from openFDA

No specific antidote has been identified for the treatment of flecainide acetate overdosage. Overdoses ranging up to 8000 mg have been survived, with peak plasma flecainide concentrations as high as 5.3 mcg/mL. Untoward effects in these cases included nausea and vomiting, convulsions, hypotension, bradycardia, syncope, extreme widening of the QRS complex, widening of the QT interval, widening of the PR interval, ventricular tachycardia, AV nodal block, asystole, bundle branch block, cardiac failure, and cardiac arrest. The spectrum of events observed in fatal cases was much the same as that seen in the non-fatal cases. Death has resulted following ingestion of as little as 1000 mg; concomitant overdose of other drugs and/or alcohol in many instances undoubtedly contributed to the fatal outcome. Treatment of overdosage should be supportive and may include the following: removal of unabsorbed drug from the gastrointestinal tract, administration of inotropic agents or cardiac stimulants such as dopamine, dobutamine or isoproterenol; mechanically assisted respiration; circulatory assists such as intra-aortic balloon pumping; and transvenous pacing in the event of conduction block.

Approval history

Sourced from openFDA
  • Jul 31, 2001ANDAANDA075442Amneal Pharm
  • Oct 28, 2002ANDAANDA075882Ani Pharms
  • Jan 14, 2003ANDAANDA076278Hikma
  • Jul 9, 2009ANDAANDA079164Chartwell
  • Nov 3, 2017ANDAANDA202821Aurobindo Pharma Ltd
  • Sep 16, 2020ANDAANDA210683Regcon Holdings
  • Sep 8, 2022ANDAANDA215599Yichang Humanwell

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
5,103 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Atrial Fibrillation3446.7%
  2. 2Fatigue2835.5%
  3. 3Dyspnoea2755.4%
  4. 4Dizziness2625.1%
  5. 5Nausea2474.8%
  6. 6Drug Ineffective2204.3%
  7. 7Headache2154.2%
  8. 8Diarrhoea2144.2%
  9. 9Asthenia2024.0%
  10. 10Fall1843.6%
  11. 11Toxicity To Various Agents1733.4%
  12. 12Hypotension1713.4%
  13. 13Drug Interaction1693.3%
  14. 14Malaise1663.3%
  15. 15Cough1352.6%

Literature

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Recent PubMed references pinned to Flecainide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 74 ClinicalTrials.gov registrations naming Flecainide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

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CPIC-curated drug–gene pairs for Flecainide. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CYP2D6CPIC B/C (provisional)ClinPGx 1A

Frequently asked questions

How does Flecainide work?
Mechanism-of-action class: Ion Channel Interactions.
What is Flecainide used for?
According to FDA labeling, Flecainide carries indications including: In patients without structural heart disease, flecainide acetate tablets, USP are indicated for the prevention of — paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms — paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms Flecainide acetate tablets, USP are also indicated for the prevention of — documented ventricular arrhythmias, such as sustained ventricular tachycardia ( sustained VT), that in the judgment of the physician are life-threatening. Use of flecainide acetate tablets, USP for the treatment of sustained VT, like other antiarrhythmics, should be initiated in the hospital.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Flecainide?
Flecainide is classified as Antiarrhythmics, class Ic, Antiarrhythmic, Ion Channel Interactions, Cardiac Rhythm Alteration, Negative Inotropy.
What are the contraindications for Flecainide?
Flecainide labeling lists contraindications including: Flecainide acetate tablets are contraindicated in patients with preexisting second- or third-degree AV block, or with right bundle branch block when associated with a left hemiblock (bifascicular block), unless a pacemaker is present to sustain the cardiac rhythm should complete heart block occur. Flecainide acetate tablets are also contraindicated in the presence of cardiogenic shock or known hypersensitivity to the drug.. Always consult the full prescribing information and a clinician.
Note. Data for flecainide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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