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flecainide (Rx)Brand and Other Names:Tambocor

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 50mg
  • 100mg
  • 150mg
more...

Arrhythmias

PSVT and paroxysmal atrial fibrillation

  • 50 mg PO BID; may increase by 50 mg every 4 days; do not exceed 300 mg/day

Sustained VT

  • 100 mg PO BID initiated in hospital; may increase by 50 mg every 4 days; do not exceed 400 mg/day

Dosing Considerations

Steady-state plasma levels not achieved for 3-5 days, so increases in dosage should not be made less than every 4 days

Loading dose not recommended, due to increased incidence of proarrhythmic events and CHF

Patients intolerant to BID dosing may require 8hr dosing

Once adequate control of arrhythmia has been achieved, may reduce dose, provided there is no loss of efficacy

After 5 doses/steady state, obtain ECG after initiation or change of dose; obtain plasma trough flecainide levels 1 hour predose

Usual trough plasma levels: 0.2-1 mcg/mL

When given concomitantly with amiodarone, reduce flecainide dose by 50% and monitor closely

Dose cautiously in patients with history of MI or CHF

When switching from another antiarrhythmic to flecainide, allow >2-4 plasma half-lives to elapse before starting flecainide; if discontinuation of previous drug may produce life-threatening arrhythmias, consider hospitalizing patient

Dosing Modifications

Renal impairment

  • Severe (<35 mL/min): 100 mg PO qDay or 50 mg PO BID
  • >25 mL/min: 100 mg PO BID

Hepatic impairment

  • Use only if benefits outweigh risk; monitor plasma levels regularly; reduce dose as necessary

Administration

May take with food

Dosage Forms & Strengths

tablet

  • 50mg
  • 100mg
  • 150mg
more...

Arrhythmias

<6 months: 50 mg/m²/day divided q8-12hr  

>6 months: 100 mg/m²/day divided q8-12hr

Not to exceed 200 mg/m²/day

Dosing Considerations

Usual therapeutic level: 200-500 ng/mL; some may require <800 ng/mL for adequate control

Steady-state plasma levels not achieved for 3-5 days, so increases in dosage should not be made less than every 4 days

Loading dose not recommended, due to increased incidence of proarrhythmic events and CHF

Patients intolerant to BID dosing may require 8hr dosing

Once adequate control of arrhythmia has been achieved, may reduce dose, provided there is no loss of efficacy

After 5 doses/steady state, obtain ECG after initiation or change of dose; obtain plasma trough flecainide levels 1 hour predose

Usual trough plasma levels: 0.2-1 mcg/mL

When given concomitantly with amiodarone, reduce flecainide dose by 50% and monitor closely

Dose cautiously in patients with history of MI or CHF

When switching from another antiarrhythmic to flecainide, allow >2-4 plasma half-lives to elapse before starting flecainide; if discontinuation of previous drug may produce life-threatening arrhythmias, consider hospitalizing patient

Dosing Modifications

Renal impairment

  • Severe (<35 mL/min): 100 mg PO qDay or 50 mg PO BID
  • >25 mL/min: 100 mg PO BID

Hepatic impairment

  • Use only if benefits outweigh risk; monitor plasma levels regularly; reduce dose as necessary

Administration

May take with food

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Interactions

Interaction Checker

flecainide and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
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            Adverse Effects

            >10%

            Visual disturbances (5-16%)

            Dizziness (10-19%)

            1-10%

            Arrhythmias

            Edema (1-4%)

            Asthenia (2-5%)

            Palpitations (2-7%)

            Fatigue (3-8%)

            Tremors (2-5%)

            Constipation (1-4%)

            Nausea (5-9%)

            Chest pain (1-5%)

            Dyspnea (5-10%)

            Headache (5-10%)

            Abdominal pain (1-3%)

            Malaise (1-3%)

            Fever (1-3%)

            Tachycardia (1-3%)

            Sinus pause/arrest (1-3%)

            Vomiting (1-3%)

            Diarrhea (1-3%)

            Dyspepsia (1-3%)

            Anorexia (1-3%)

            Rash (1-3%)

            Diplopia (1-3%)

            Hypoesthesia (1-3%)

            Paresthesia (1-3%)

            Paresis (1-3%)

            Ataxia (1-3%)

            Flushing (1-3%)

            Diaphoresis (1-3%)

            Vertigo (1-3%)

            Syncope (1-3%)

            Somnolence (1-3%)

            Tinnitus (1-3%)

            Anxiety (1-3%)

            Insomnia (1-3%)

            Depression (1-3%)

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            Warnings

            Black Box Warnings

            Mortality

            • NHLBI’s Cardiac Arrhythmia Suppression Trial (CAST): Excessive mortality or nonfatal cardiac arrest (7.7%) shown with encainide or flecainide, compared with placebo (3%)
            • This was a long-term, multicenter, randomized, double-blind study in patients with asymptomatic, non-life-threatening ventricular arrhythmias who previously had MI >6 days but <2 yr
            • Average duration of treatment with encainide or flecainide was 10 months
            • Applicability of results to other populations is uncertain
            • Reserve class IC antiarrhythmics use for life-threatening ventricular arrhythmias only
            • Due to known proarrhythmic properties of flecainide and lack of evidence of improved survival for any antiarrhythmics, flecainide use should be restricted to patients with life-threatening ventricular arrhythmias

            Ventricular proarrhythmic effects with AF/flutter

            • Not recommended for chronic atrial fibrillation
            • 10.5% incidence of ventricular tachycardia/fibrillation in patients treated for chronic atrial fibrillation
            • Proarrhythmic effects with flecainide for atrial fibrillation/flutter: Increased risk of PVCs, ventricular tachycardia, ventricular fibrillation, and fatality
            • As with other class I agents, use of flecainide for atrial flutter has been reported with 1:1 atrioventricular conduction due to atrial rate slowing
            • Paradoxical increase in ventricular rate may occur in patients with atrial fibrillation; concomitant negative chronotropic therapy (eg, digoxin, beta blockers) may lower risk

            Contraindications

            Hypersensitivity

            2nd or 3rd degree AV block, right bundle branch block when associated with left hemiblock (bifascicular block), unless pacemaker is present to sustain cardiac rhythm; discontinue therapy immediately

            Cautions

            Atrial fibrillation, CHF, hypotension, HTN, post MI patients, geriatrics, proarrhythmia events, hepatic/renal impairment, sick sinus syndrome

            May slow cardiac conduction to produce dose-related increases in PR, QRS, and QT intervals; manage patient on lowest effective dose

            Discontinuation should be done in hospital

            Causes increased mortality in post-AMI period, also with chronic atrial fibrillation

            May affect endocardial pacemaker reversibly by increasing endocardial pacing thresholds or suppressing ventricular escape rhythms; do not administer to patients with existing poor thresholds or nonprogrammable pacemakers unless suitable pacing rescue is available

            Correct preexisting hypokalemia or hyperkalemia before initiating therapy

            May cause visual disturbances

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            Pregnancy & Lactation

            Pregnancy category: C

            Lactation: Enters breast milk

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Mechanism of Action

            Class IC antidysrhythmic; slows conduction in cardiac tissue by altering transport of ion across membranes; causes slight prolongation of refractory periods, decreases rate of rise of action potential without affecting its duration; local anesthetic and moderate negative inotropic effects

            Absorption

            Bioavailability: 85-90%

            Peak plasma time: 2-3 hr (PO)

            Therapeutic range: 0.2-1 mcg/mL

            Toxicity range: >0.7-1 mcg/mL

            Distribution

            Protein bound: 40-50%

            Vd: 5.5-8.7 L/kg

            Metabolism

            Undergoes extensive biotransformation to 2 major and several minor metabolites; subject to genetic polymorphism; R-enantiomer is metabolized by hepatic CYP2D6

            Metabolites: Meta-O-dealkylated flecainide, meta-O-dealkylated lactam of flecainide (inactive)

            Elimination

            Half-life: 12 to 27hr; t1/2 increased in renal impairment

            Dialyzable: Yes (HD)

            Total plasma clearance: 10 mL/min/kg

            Excretion: Urine (80-90%), which increases with low urine pH; feces (minor)

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
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            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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