(fle KAY nide)
- Flecainide Acetate
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral, as acetate:
Tambocor: 50 mg [DSC], 100 mg [DSC], 150 mg [DSC]
Generic: 50 mg, 100 mg, 150 mg
Brand Names: U.S.
- Tambocor [DSC]
- Antiarrhythmic Agent, Class Ic
Class Ic antiarrhythmic; slows conduction in cardiac tissue by altering transport of ions across cell membranes; causes slight prolongation of refractory periods; decreases the rate of rise of the action potential without affecting its duration; increases electrical stimulation threshold of ventricle, His-Purkinje system; possesses local anesthetic and moderate negative inotropic effects
Oral: Nearly complete; decreased when administered with milk
Urine (30% [range: 10% to 50%] as unchanged drug); feces (5%)
Time to Peak
Serum: ~3 hours (range: 1 to 6 hours)
Newborns: Up to ≤29 hours; 3 months: 11 to 12 hours; 12 months: 6 hours
Children: ~8 hours
Adolescents 12 to 15 years: ~11 to 12 hours
Adults: ~20 hours (range: 12 to 27 hours); increased in patients with heart failure (NYHA Class III) or renal dysfunction
Use: Labeled Indications
Paroxysmal atrial fibrillation/flutter and paroxysmal supraventricular tachycardias (prevention): For the prevention of paroxysmal atrial fibrillation/flutter associated with disabling symptoms and paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia, and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms in patients without structural heart disease.
Guideline recommendations: Due to safety risks, flecainide should be reserved for symptomatic supraventricular tachycardias (SVTs) in patients without structural or ischemic heart disease who are not candidates for, or prefer not to undergo, catheter ablation and in whom other therapies have failed or are contraindicated (ACC/AHA/HRS [Page 2015]).
Ventricular arrhythmias (prevention): Prevention of documented life-threatening ventricular tachyarrhythmias (eg, sustained ventricular tachycardia) in patients without structural heart disease.
Limitations of use: Use of flecainide is not recommended in patients with less severe ventricular arrhythmias, even if symptomatic. Because of the proarrhythmic effects of flecainide, its use should be reserved for patients in whom the benefits of treatment outweigh the risks. Flecainide should not be used in patients with chronic atrial fibrillation (not adequately studied) or recent MI. No evidence from controlled trials have demonstrated favorable effects of flecainide on survival or the incidence of sudden death.
Atrial fibrillation or flutter (pharmacologic cardioversion)
Hypersensitivity to flecainide or any component of the formulation; pre-existing second- or third-degree AV block or with right bundle branch block when associated with a left hemiblock (bifascicular block) (except in patients with a functioning artificial pacemaker); cardiogenic shock; concurrent use of ritonavir
According to the American College of Cardiology/American Heart Association/European Society of Cardiology, the use of flecainide is considered contraindicated in patients with structural heart disease (ACC/AHA/ESC [Blomstrom-Lundqvist 2003]).
Ventricular arrhythmias (prevention): Oral:
Initial: 100 mg every 12 hours; increase by 50 mg twice daily at 4-day intervals; maximum: 400 mg per day. Some patients inadequately controlled with or intolerant to dosing every 12 hours may require dosing every 8 hours. Note: Initiate therapy in a hospital setting in patients with sustained ventricular tachycardia. Use of higher initial doses and more rapid dosage adjustments have resulted in an increased incidence of proarrhythmic events and congestive heart failure, particularly during the first few days. Do not use a loading dose. Use very cautiously in patients with history of congestive heart failure or myocardial infarction.
Paroxysmal atrial fibrillation/flutter and paroxysmal supraventricular tachycardias (prevention): Oral: Initial: 50 mg every 12 hours; increase by 50 mg twice daily at 4-day intervals; maximum total dose: 300 mg. The AHA/ACC/HRS atrial fibrillation guidelines recommend a maximum total daily dose of 400 mg (AHA/ACC/HRS [January 2014]).
Atrial fibrillation or flutter (pharmacological cardioversion) (off-label dose): Oral: Note: May be used on an outpatient basis (“Pill-in-the-pocket”). An initial inpatient cardioversion trial should have been successful before sending patient home on this approach. Patient must be taking an AV nodal-blocking agent (eg, beta-blocker, nondihydropyridine calcium channel blocker) prior to initiation of antiarrhythmic (AHA/ACC/HRS [January 2014]; Alboni 2004).
<70 kg: 200 mg; may not repeat in ≤24 hours
≥70 kg: 300 mg; may not repeat in ≤24 hours
Conversion from another antiarrhythmic agent: Allow for 2 to 4 half-lives of the other agent after discontinuation to pass before initiating flecainide therapy.
Dosage adjustment for concomitant therapy: Amiodarone: Reduce the flecainide dose by 50% and monitor the patient closely for adverse effects; monitoring of plasma concentrations is strongly recommended to guide dosage.
Refer to adult dosing.
Arrhythmias (prevention): Manufacturer's labeling: BSA-directed dosing: Use caution with dose titration, as small change in dose may result in disproportionate increase in plasma concentrations.
Infants ≤6 months: Oral: Initial: 50 mg/m2/day divided every 8 to 12 hours; may titrate dose at 4 day intervals; maximum daily dose: 200 mg/m2/day; higher doses have been associated with an increased risk of proarrhythmic effects
Infants >6 months, Children, and Adolescents: Oral: Initial: 100 mg/m2/day divided every 8 to 12 hours; may titrate dose at 4 day intervals; maximum daily dose: 200 mg/m2/day; higher doses have been associated with an increased risk of proarrhythmic effects
Dosing: Renal Impairment
CrCl >35 mL/minute/1.73 m2: Adults: Initial: 100 mg every 12 hours; consider obtaining plasma concentrations to guide dosage adjustments. Dose increases should be made very cautiously at intervals >4 days.
CrCl ≤35 mL/minute/1.73 m2: Adults: Initial: 100 mg once daily or 50 mg every 12 hours; obtain plasma concentrations to guide dosage adjustments. Dose increases should be made very cautiously at intervals >4 days and serum trough concentrations monitored frequently. In patients with end stage renal disease, renal clearance is very low as compared to patients with moderate renal impairment and the plasma half-life may extend up to 58 hours (Conard 1984).
Hemodialysis: Removal by hemodialysis is negligible (only ~1% of an oral dose)
Dosing: Hepatic Impairment
There are no dosage adjustments provided in the manufacturer’s labeling; however elimination from the plasma may be slower in patients with hepatic impairment. Use with caution; obtain plasma concentrations to guide dosage adjustments. Dose increases should be made very cautiously at intervals >4 days and serum concentrations monitored frequently. Frequent plasma level monitoring is required in patients with severe hepatic impairment; if unavailable, use is not recommended.
A 20 mg/mL oral liquid suspension may be made from tablets and one of three different vehicles (cherry syrup, a 1:1 mixture of Ora-Sweet® and Ora-Plus®, or a 1:1 mixture of Ora-Sweet® SF and Ora-Plus®). Crush twenty-four 100 mg tablets in a mortar and reduce to a fine powder. Add 20 mL of the chosen vehicle and mix to a uniform paste; mix while adding the vehicle in incremental proportions to almost 120 mL; transfer to a calibrated bottle, rinse mortar with vehicle, and add quantity of vehicle sufficient to make 120 mL. Label “shake well” and “protect from light”. Stable for 60 days when stored in amber plastic prescription bottles in the dark at room temperature or refrigerated.Allen LV and Erickson III MA, “Stability of Baclofen, Captopril, Diltiazem, Hydrochloride, Dipyridamole, and Flecainide Acetate in Extemporaneously Compounded Oral Liquids,” Am J Health Syst Pharm. 1996, 53:2179-84.8879325
Store at 20°C to 25°C (68°F to 77°F) in a tight, light-resistant container
Abiraterone Acetate: May increase the serum concentration of CYP2D6 Substrates. Management: Avoid concurrent use of abiraterone with CYP2D6 substrates that have a narrow therapeutic index whenever possible. When concurrent use is not avoidable, monitor patients closely for signs/symptoms of toxicity. Consider therapy modification
Amiodarone: May enhance the QTc-prolonging effect of Flecainide. Amiodarone may increase the serum concentration of Flecainide. Management: Decrease flecainide dose by 50% in the presence of amiodarone. Monitor for adverse effects of flecainide and consider monitoring for elevated serum concentrations during concomitant therapy. Consider therapy modification
Antihepaciviral Combination Products: May increase the serum concentration of Flecainide. Management: Canadian labeling recommends avoiding this combination. Monitor therapy
Asunaprevir: May increase the serum concentration of Flecainide. Avoid combination
Boceprevir: May increase the serum concentration of Flecainide. Monitor therapy
Carbonic Anhydrase Inhibitors: May increase the serum concentration of Flecainide. Exceptions: Brinzolamide; Dorzolamide. Monitor therapy
Cobicistat: May increase the serum concentration of CYP2D6 Substrates. Monitor therapy
CYP2D6 Inhibitors (Moderate): May decrease the metabolism of CYP2D6 Substrates. Monitor therapy
CYP2D6 Inhibitors (Strong): May decrease the metabolism of CYP2D6 Substrates. Consider therapy modification
Darunavir: May increase the serum concentration of CYP2D6 Substrates. Monitor therapy
Digoxin: Flecainide may increase the serum concentration of Digoxin. Monitor therapy
Etravirine: May decrease the serum concentration of Flecainide. Monitor therapy
Fosamprenavir: May increase the serum concentration of Flecainide. Management: Concurrent use of ritonavir-boosted fosamprenavir with flecainide is contraindicated. The use of non-ritonavir-boosted fosamprenavir with flecainide is not specifically contraindicated but should only be undertaken with caution. Avoid combination
Highest Risk QTc-Prolonging Agents: Moderate Risk QTc-Prolonging Agents may enhance the QTc-prolonging effect of Highest Risk QTc-Prolonging Agents. Avoid combination
Imatinib: May increase the serum concentration of CYP2D6 Substrates. Monitor therapy
Ivabradine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination
MiFEPRIStone: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination
Mirabegron: May increase the serum concentration of Flecainide. Management: Monitor clinical response to flecainide closely. Dose adjustment may be necessary. Canadian mirabegron labeling recommends restricting the maximum adult mirabegron dose to 25 mg/day in patients receiving flecainide. Monitor therapy
Moderate Risk QTc-Prolonging Agents: May enhance the QTc-prolonging effect of other Moderate Risk QTc-Prolonging Agents. Management: Avoid such combinations when possible. Use should be accompanied by close monitoring for evidence of QT prolongation or other alterations of cardiac rhythm. Consider therapy modification
Panobinostat: May increase the serum concentration of CYP2D6 Substrates. Management: Avoid concurrent use of sensitive CYP2D6 substrates when possible, particularly those substrates with a narrow therapeutic index. Consider therapy modification
Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates. Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates. Monitor therapy
Perhexiline: CYP2D6 Substrates may increase the serum concentration of Perhexiline. Perhexiline may increase the serum concentration of CYP2D6 Substrates. Monitor therapy
Pindolol: Flecainide may enhance the bradycardic effect of Pindolol. The negative inotropic effects of Pindolol may also be enhanced. Monitor therapy
Probucol: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination
Promazine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination
QTc-Prolonging Agents (Indeterminate Risk and Risk Modifying): May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Monitor therapy
Ritonavir: May increase the serum concentration of Flecainide. Avoid combination
Saquinavir: May enhance the arrhythmogenic effect of Flecainide. Saquinavir may increase the serum concentration of Flecainide. Avoid combination
Simeprevir: May increase the serum concentration of Flecainide. Monitor therapy
Sodium Bicarbonate: May diminish the arrhythmogenic effect of Flecainide. Sodium Bicarbonate may increase the serum concentration of Flecainide. Monitor therapy
Sodium Lactate: May increase the serum concentration of Flecainide. Monitor therapy
Telaprevir: May enhance the adverse/toxic effect of Flecainide. Monitor therapy
Tipranavir: May increase the serum concentration of Flecainide. Avoid combination
Tromethamine: May increase the serum concentration of Flecainide. Monitor therapy
Verapamil: May enhance the adverse/toxic effect of Flecainide. In particular, this combination may significantly impair myocardial contractility and AV nodal conduction. Monitor therapy
Vinflunine: May enhance the QTc-prolonging effect of Moderate Risk QTc-Prolonging Agents. Avoid combination
Central nervous system: Dizziness (19% to 30%)
Ocular: Visual disturbances (16%)
Respiratory: Dyspnea (~10%)
1% to 10%:
Cardiovascular: Palpitation (6%), chest pain (5%), edema (3.5%), tachycardia (1% to 3%), proarrhythmic (4% to 12%), sinus node dysfunction (1.2%), syncope
Central nervous system: Headache (4% to 10%), fatigue (8%), nervousness (5%) additional symptoms occurring at a frequency between 1% and 3%: fever, malaise, hypoesthesia, paresis, ataxia, vertigo, somnolence, tinnitus, anxiety, insomnia, depression
Dermatologic: Rash (1% to 3%)
Gastrointestinal: Nausea (9%), constipation (1%), abdominal pain (3%), anorexia (1% to 3%), diarrhea (0.7% to 3%)
Neuromuscular & skeletal: Tremor (5%), weakness (5%), paresthesia (1%)
Ocular: Diplopia (1% to 3%), blurred vision
<1% (Limited to important or life-threatening): Alopecia, alters pacing threshold, amnesia, angina, AV block, bradycardia, bronchospasm, CHF, corneal deposits, depersonalization, euphoria, exfoliative dermatitis, granulocytopenia, heart block, increased P-R, leukopenia, metallic taste, neuropathy, paradoxical increase in ventricular rate in atrial fibrillation/flutter, paresthesia, photophobia, pneumonitis, pruritus, QRS duration, swollen lips/tongue/mouth, tardive dyskinesia, thrombocytopenia, urinary retention, urticaria, ventricular arrhythmia
Concerns related to adverse effects:
• Proarrhythmic effects: [US Boxed Warning]: Proarrhythmic effects (including increased premature ventricular contractions, ventricular tachycardia, ventricular fibrillation, and death) have been reported in patients with atrial fibrillation/fibrillation who received flecainide; use is not recommended for patients with chronic atrial fibrillation. Flecainide can cause new or worsened supraventricular or ventricular arrhythmias in all patients; effect is dose-related. Patients with sustained ventricular tachycardia and serious underlying heart disease are at an increased risk; initiation of therapy should occur in a hospital setting.
• Atrial fibrillation (chronic): Use is not recommended in patients with chronic atrial fibrillation due to an increased risk of life-threatening ventricular arrhythmias.
• Atrial flutter: Appropriate use: [US Boxed Warning]: When treating atrial flutter, 1:1 atrioventricular conduction may occur; pre-emptive negative chronotropic therapy (eg, digoxin, beta-blockers) may lower the risk.
• Conduction disturbances: Dose-related increases in PR and QRS intervals occur. If second- or third-degree AV block, or right bundle branch block associated with a left hemiblock occur, flecainide therapy should be discontinued unless a temporary or implanted ventricular pacemaker is in place to ensure an adequate ventricular rate. Use with extreme caution in patients with sick sinus syndrome; treatment with flecainide may result in sinus bradycardia, sinus pause, or sinus arrest.
• Electrolyte imbalance: Correct electrolyte disturbances, especially hypokalemia or hypomagnesemia, prior to use and throughout therapy.
• Heart disease: Avoid use in patients with heart failure; may precipitate or exacerbate condition, increase the risk of proarrhythmia, and contribute to an increased risk of mortality (ACCF/AHA [Yancy 2013]). According to the manufacturer, use with extreme caution in patients with structural heart disease as the risk of death and cardiac events may be increased. According to the ACC/AHA/HRS, flecainide should be avoided in patients with structural or ischemic heart disease (ACC/AHA/HRS [Page 2015]).
• Hepatic impairment: Use with caution in patients with significant hepatic impairment; benefit should outweigh risk. Consider careful monitoring during initiation of therapy. Dose titration should occur only after steady state has been achieved (≥4 days after initiation). Frequent plasma level monitoring is required in patients with severe hepatic impairment; if unavailable, use is not recommended.
• Renal impairment: Use with caution in patients with significant renal impairment. Frequent plasma level monitoring is required in patients with severe renal impairment; if unavailable, use is not recommended.
Concurrent drug therapy issues:
• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
• Pediatric: Small changes in dose may lead to disproportionate increases in plasma concentrations in pediatric patients. Following initiation of therapy or changes in dose, obtain plasma trough concentrations and ECG once steady state has been achieved (>5 doses after initiation or change); regular monitoring of trough concentrations and ECG is recommended by the manufacturer during the first year of therapy.
• CAST trial: [US Boxed Warning]: In the Cardiac Arrhythmia Suppression Trial (CAST), recent (>6 days but <2 years ago) myocardial infarction patients with asymptomatic, non-life-threatening ventricular arrhythmias did not benefit and may have been harmed by attempts to suppress the arrhythmia with flecainide or encainide. An increased mortality or nonfatal cardiac arrest rate (7.7%) was seen in the active treatment group compared with patients in the placebo group (3%). The applicability of the CAST results to other populations is unknown. The risks of class 1C agents and the lack of improved survival make use in patients without life-threatening arrhythmias generally unacceptable.
• Pacemakers: Use with caution in patients with permanent pacemakers or temporary pacing wires; can increase endocardial pacing thresholds and suppress ventricular escape rhythms. Do not use in patients with existing poor thresholds or nonprogrammable pacemakers unless suitable pacing rescue is available. The pacing threshold in patients with pacemakers should be determined at baseline, 1 week after initiation and at regular intervals thereafter.
ECG, blood pressure, pulse, periodic serum trough concentrations, especially in patients with renal or hepatic impairment, concomitant administration of amiodarone and pediatric patients.
Pregnancy Risk Factor
Adverse events have been observed in some animal reproduction studies. Flecainide is recommended in the treatment of fetal tachycardia determined to be SVT. Flecainide may be also used for the ongoing management of SVT in highly symptomatic pregnant patients. The lowest effective dose is recommended; avoid use during the first trimester if possible (Page [ACC/AHA/HRS 2015]). Additional guidelines are available for management of cardiovascular diseases during pregnancy (ESG [Regitz-Zagrosek 2011]).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience headache. Have patient report immediately to prescriber signs of hepatic impairment, angina, severe dizziness, syncope, arrhythmia, bradycardia, tachycardia, dyspnea, excessive weight gain, edema of extremities, tremors, vision changes, ecchymosis, or hemorrhaging (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
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Other brands: Tambocor