flecainide (Rx)

Brand and Other Names:Tambocor
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 50mg
  • 100mg
  • 150mg

Arrhythmias (Prevention)

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

Dosage 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

Narcolepsy (Orphan)

Orphan designation of a fixed dose combination of modafinil and flecainide for narcolepsy

Sponsor

  • Theranexus SA; 86 Rue de Paris; Orsay, France

Dosage Forms & Strengths

tablet

  • 50mg
  • 100mg
  • 150mg

Arrhythmias

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

≥6 months: 100 mg/m²/day PO 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

Dosage 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
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Interactions

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            Contraindicated (1)

            • tipranavir

              tipranavir will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Contraindicated. Coadministration may result in flecainide-induced QT prolongation

            Serious - Use Alternative (48)

            • alfuzosin

              alfuzosin and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • aripiprazole

              aripiprazole and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • arsenic trioxide

              arsenic trioxide and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • artemether

              artemether and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • artemether/lumefantrine

              artemether/lumefantrine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

            • atomoxetine

              atomoxetine and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • ceritinib

              ceritinib and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • clozapine

              clozapine and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • dacomitinib

              dacomitinib will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid use with CYP2D6 substrates where minimal increases in concentration of the CYP2D6 substrate may lead to serious or life-threatening toxicities.

            • degarelix

              degarelix and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • desflurane

              desflurane and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • deutetrabenazine

              deutetrabenazine and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • digoxin

              flecainide increases effects of digoxin by unknown mechanism. Avoid or Use Alternate Drug.

            • disopyramide

              disopyramide and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • dofetilide

              dofetilide and flecainide both increase QTc interval. Avoid or Use Alternate Drug. Additive cardiac effects.

            • entrectinib

              flecainide and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.

            • eribulin

              eribulin and flecainide both increase QTc interval. Avoid or Use Alternate Drug. Potential for enhanced QTc-prolonging effects; if concurrent use is necessary then ECG monitoring is recommended.

            • escitalopram

              escitalopram increases toxicity of flecainide by QTc interval. Avoid or Use Alternate Drug.

            • fexinidazole

              fexinidazole and flecainide both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.

            • fluoxetine

              fluoxetine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

            • givosiran

              givosiran will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP2D6 substrates with givosiran. If unavoidable, decrease the CYP2D6 substrate dosage in accordance with approved product labeling.

            • glasdegib

              flecainide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • ibutilide

              flecainide and ibutilide both increase QTc interval. Avoid or Use Alternate Drug.

            • indapamide

              flecainide and indapamide both increase QTc interval. Avoid or Use Alternate Drug.

            • inotuzumab

              inotuzumab and flecainide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

            • ivosidenib

              ivosidenib and flecainide both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.

            • lefamulin

              lefamulin and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • lumefantrine

              lumefantrine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

            • macimorelin

              macimorelin and flecainide both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.

            • mobocertinib

              mobocertinib and flecainide both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, reduce mobocertinib dose and monitor QTc interval more frequently.

            • ondansetron

              flecainide and ondansetron both increase QTc interval. Avoid or Use Alternate Drug. Avoid with congenital long QT syndrome; ECG monitoring recommended with concomitant medications that prolong QT interval, electrolyte abnormalities, CHF, or bradyarrhythmias.

            • panobinostat

              flecainide and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.

            • paroxetine

              paroxetine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

            • pentamidine

              flecainide and pentamidine both increase QTc interval. Avoid or Use Alternate Drug.

            • pimozide

              flecainide and pimozide both increase QTc interval. Avoid or Use Alternate Drug.

            • pitolisant

              flecainide and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.

            • ponesimod

              ponesimod, flecainide. Either increases effects of the other by pharmacodynamic synergism. Avoid or Use Alternate Drug. Consult cardiologist if considering treatment. Coadministration of ponesimod with drugs that decrease HR may have additive effects on decreasing HR and should generally not be initiated in these patients.

            • procainamide

              flecainide and procainamide both increase QTc interval. Avoid or Use Alternate Drug.

            • quinidine

              quinidine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug.

              quinidine and flecainide both increase QTc interval. Avoid or Use Alternate Drug.

            • ribociclib

              ribociclib increases toxicity of flecainide by QTc interval. Avoid or Use Alternate Drug.

            • ritonavir

              ritonavir will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Contraindicated. Concurrent use of flecainide and ritonavir is contraindicated.

              ritonavir increases levels of flecainide by decreasing metabolism. Contraindicated.

            • romidepsin

              flecainide and romidepsin both increase QTc interval. Avoid or Use Alternate Drug.

            • sotalol

              flecainide and sotalol both increase QTc interval. Avoid or Use Alternate Drug.

            • umeclidinium bromide/vilanterol inhaled

              flecainide increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • vandetanib

              flecainide, vandetanib. Either increases toxicity of the other by QTc interval. Avoid or Use Alternate Drug. Avoid coadministration with drugs known to prolong QT interval; if a drug known to prolong QT interval must be used, more frequent ECG monitoring is recommended.

            • vemurafenib

              vemurafenib increases levels of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Avoid or Use Alternate Drug. Concomitant use of vemurafenib with agents with narrow therapeutic windows is not recommended as vemurafenib may alter their concentrations. If coadministration cannot be avoided, use caution and consider dose reduction of concomitant CYP2D6 substrate drug. Combination may increase risk QT prolongation.

            • vilanterol/fluticasone furoate inhaled

              flecainide increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            Monitor Closely (130)

            • abiraterone

              abiraterone increases levels of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Avoid coadministration of abiraterone with substrates of CYP2D6. If alternative therapy cannot be used, exercise caution and consider a dose reduction of the CYP2D6 substrate.

            • acetazolamide

              acetazolamide will increase the level or effect of flecainide by passive renal tubular reabsorption - basic urine. Use Caution/Monitor.

            • albuterol

              albuterol and flecainide both increase QTc interval. Use Caution/Monitor.

            • aluminum hydroxide

              aluminum hydroxide will increase the level or effect of flecainide by passive renal tubular reabsorption - basic urine. Use Caution/Monitor.

            • amiodarone

              amiodarone and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • amitriptyline

              amitriptyline and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • amoxapine

              amoxapine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • arformoterol

              arformoterol and flecainide both increase QTc interval. Use Caution/Monitor.

            • artemether/lumefantrine

              flecainide and artemether/lumefantrine both increase QTc interval. Modify Therapy/Monitor Closely.

            • asenapine

              asenapine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • bedaquiline

              flecainide and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely

            • bupropion

              bupropion will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Coadministration of bupropion and flecainide should be approached with caution and should be initiated at the lower end of the dose range of flecainide. If bupropion is added to the treatment regimen of a patient already receiving flecainide, consider decreasing the dose of flecainide.

            • calcium carbonate

              calcium carbonate will increase the level or effect of flecainide by passive renal tubular reabsorption - basic urine. Use Caution/Monitor.

            • celecoxib

              celecoxib will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • chloroquine

              chloroquine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              chloroquine increases toxicity of flecainide by QTc interval. Use Caution/Monitor.

            • chlorpromazine

              chlorpromazine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • cimetidine

              cimetidine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Flecainide dosage should be carefully titrated on initiation of therapy. Careful monitoring of flecainide plasma concentration should be instituted when cimetidine is coadministered or discontinued.

            • ciprofloxacin

              ciprofloxacin and flecainide both increase QTc interval. Use Caution/Monitor. Ciprofloxacin elicits minimal effects on QT interval. Caution if used in combination with other drugs known to affect QT interval or in patients with other risk factors.

            • citalopram

              flecainide and citalopram both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

            • clarithromycin

              clarithromycin and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • clobazam

              clobazam will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Lower doses of drugs metabolized by CYP2D6 may be required when used concomitantly.

            • clomipramine

              clomipramine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • cobicistat

              cobicistat will increase the level or effect of flecainide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Clinical monitoring is recommended upon coadministration with antiarrhythmics.

            • crizotinib

              crizotinib and flecainide both increase QTc interval. Use Caution/Monitor. ECG monitoring is recommended, along with drugs that may prolong the QT interval.

            • darifenacin

              darifenacin will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • darunavir

              darunavir will increase the level or effect of flecainide by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Clinical monitoring is recommended upon coadministration with antiarrhythmics.

            • dasatinib

              dasatinib and flecainide both increase QTc interval. Use Caution/Monitor.

            • desipramine

              desipramine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • desvenlafaxine

              desvenlafaxine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Desvenlafaxine inhibits CYP2D6; with higher desvenlafaxine doses (ie, 400 mg) decrease the CYP2D6 substrate dose by up to 50%; no dosage adjustment needed with desvenlafaxine doses <100 mg

            • diphenhydramine

              diphenhydramine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • dolasetron

              dolasetron and flecainide both increase QTc interval. Use Caution/Monitor.

            • doxepin

              doxepin and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • dronedarone

              dronedarone will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              dronedarone and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • droperidol

              droperidol and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • eliglustat

              eliglustat increases levels of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Monitor therapeutic drug concentrations, as indicated, or consider reducing the dosage of the concomitant drug and titrate to clinical effect.

            • elvitegravir/cobicistat/emtricitabine/tenofovir DF

              elvitegravir/cobicistat/emtricitabine/tenofovir DF increases levels of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Cobicistat is a CYP2D6 inhibitor; caution with CYP2D6 substrates for which elevated plasma concentrations are associated with serious and/or life-threatening events.

            • epinephrine

              epinephrine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • epinephrine racemic

              epinephrine racemic and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin base

              erythromycin base and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin ethylsuccinate

              erythromycin ethylsuccinate and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin lactobionate

              erythromycin lactobionate and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • erythromycin stearate

              erythromycin stearate and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • ezogabine

              ezogabine, flecainide. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Slight and transient QT-prolongation observed with ezogabine, particularly when dose titrated to 1200 mg/day. QT interval should be monitored when ezogabine is prescribed with agents known to increase QT interval.

            • fedratinib

              fedratinib will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP2D6 substrates as necessary.

            • fluconazole

              flecainide and fluconazole both increase QTc interval. Modify Therapy/Monitor Closely.

            • fluoxetine

              flecainide and fluoxetine both increase QTc interval. Use Caution/Monitor.

            • fluphenazine

              fluphenazine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • fluvoxamine

              fluvoxamine and flecainide both increase QTc interval. Use Caution/Monitor.

            • formoterol

              flecainide and formoterol both increase QTc interval. Modify Therapy/Monitor Closely.

            • foscarnet

              flecainide and foscarnet both increase QTc interval. Use Caution/Monitor.

            • fostemsavir

              flecainide and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

            • gemtuzumab

              flecainide and gemtuzumab both increase QTc interval. Use Caution/Monitor.

            • goserelin

              goserelin increases toxicity of flecainide by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • haloperidol

              haloperidol will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. If concurrent use cannot be avoided, cautious dosing and telemetric monitoring is advised.

              flecainide and haloperidol both increase QTc interval. Modify Therapy/Monitor Closely.

            • hawthorn

              hawthorn increases effects of flecainide by pharmacodynamic synergism. Use Caution/Monitor.

            • histrelin

              histrelin increases toxicity of flecainide by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • iloperidone

              flecainide and iloperidone both increase QTc interval. Use Caution/Monitor.

            • imatinib

              imatinib will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • imipramine

              imipramine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • indacaterol, inhaled

              indacaterol, inhaled, flecainide. QTc interval. Use Caution/Monitor. Drugs that are known to prolong the QTc interval may have an increased the risk of ventricular arrhythmias.

            • itraconazole

              flecainide and itraconazole both increase QTc interval. Modify Therapy/Monitor Closely.

            • ketoconazole

              flecainide and ketoconazole both increase QTc interval. Modify Therapy/Monitor Closely.

            • lapatinib

              flecainide and lapatinib both increase QTc interval. Use Caution/Monitor.

            • lenvatinib

              flecainide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.

            • leuprolide

              leuprolide increases toxicity of flecainide by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • levofloxacin

              flecainide and levofloxacin both increase QTc interval. Use Caution/Monitor.

            • lofepramine

              lofepramine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • lorcaserin

              lorcaserin will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • lumefantrine

              flecainide and lumefantrine both increase QTc interval. Modify Therapy/Monitor Closely.

            • maprotiline

              maprotiline and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • maraviroc

              maraviroc will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • marijuana

              marijuana will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • methadone

              flecainide and methadone both increase QTc interval. Use Caution/Monitor.

            • mifepristone

              mifepristone, flecainide. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.

            • mirabegron

              mirabegron will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • moxifloxacin

              flecainide and moxifloxacin both increase QTc interval. Modify Therapy/Monitor Closely.

            • nilotinib

              nilotinib will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              flecainide and nilotinib both increase QTc interval. Modify Therapy/Monitor Closely.

            • nortriptyline

              nortriptyline and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • octreotide

              flecainide and octreotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • octreotide (Antidote)

              flecainide and octreotide (Antidote) both increase QTc interval. Modify Therapy/Monitor Closely.

            • ofloxacin

              flecainide and ofloxacin both increase QTc interval. Use Caution/Monitor.

            • olodaterol inhaled

              flecainide and olodaterol inhaled both increase QTc interval. Use Caution/Monitor. Drugs that prolong the QTc interval and may potentiate the effects of beta2 agonists on the cardiovascular system; increased risk of ventricular arrhythmias

            • ombitasvir/paritaprevir/ritonavir & dasabuvir

              ombitasvir/paritaprevir/ritonavir & dasabuvir will increase the level or effect of flecainide by decreasing metabolism. Modify Therapy/Monitor Closely. Caution is warranted and therapeutic concentration monitoring (if available) is recommended for antiarrhythmics when coadministered with Viekira Pak

            • oritavancin

              oritavancin will decrease the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Oritavancin is a weak CYP2D6 inducer; caution if coadministered with CYP2D6 substrates that have a narrow therapeutic index

            • osilodrostat

              osilodrostat and flecainide both increase QTc interval. Use Caution/Monitor.

            • osimertinib

              osimertinib and flecainide both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.

            • oxaliplatin

              oxaliplatin will increase the level or effect of flecainide by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.

            • ozanimod

              ozanimod and flecainide both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.

            • paliperidone

              flecainide and paliperidone both increase QTc interval. Use Caution/Monitor.

            • parecoxib

              parecoxib will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • paroxetine

              flecainide and paroxetine both increase QTc interval. Use Caution/Monitor.

            • pasireotide

              flecainide and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • peginterferon alfa 2b

              peginterferon alfa 2b, flecainide. Other (see comment). Use Caution/Monitor. Comment: When patients are administered peginterferon alpha-2b with CYP2D6 substrates, the therapeutic effect of these drugs may be altered. Peginterferon alpha-2b may increase or decrease levels of CYP2D6 substrate.

            • perphenazine

              perphenazine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              perphenazine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • posaconazole

              flecainide and posaconazole both increase QTc interval. Use Caution/Monitor.

            • prochlorperazine

              prochlorperazine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • promazine

              promazine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • promethazine

              promethazine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • propafenone

              propafenone will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • propranolol

              flecainide, propranolol. Either increases levels of the other by decreasing metabolism. Use Caution/Monitor. Increased serum levels of both agents; additive negative inotropic effects.

            • protriptyline

              protriptyline and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • quetiapine

              quetiapine, flecainide. Either increases toxicity of the other by QTc interval. Use Caution/Monitor. Avoid use with drugs that prolong QT and in patients with risk factors for prolonged QT interval. Postmarketing cases show QT prolongation with overdose in patients with concomitant illness or with drugs known to cause electrolyte imbalance or prolong QT.

            • quinacrine

              quinacrine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

            • quinine

              flecainide and quinine both increase QTc interval. Use Caution/Monitor.

            • ranolazine

              ranolazine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              flecainide and ranolazine both increase QTc interval. Use Caution/Monitor.

            • rilpivirine

              rilpivirine increases toxicity of flecainide by QTc interval. Use Caution/Monitor. Rilpivirine should be used with caution when co-administered with a drug with a known risk of Torsades de Pointes.

            • risperidone

              flecainide and risperidone both increase QTc interval. Use Caution/Monitor.

            • rolapitant

              rolapitant will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor. Rolapitant may increase plasma concentrations of CYP2D6 substrates for at least 28 days following rolapitant administration.

            • saquinavir

              saquinavir increases levels of flecainide by QTc interval. Modify Therapy/Monitor Closely. Potential for increased toxicity. Increased risk of QT prolongation and cardiac arrhythmias.

            • selpercatinib

              selpercatinib increases toxicity of flecainide by QTc interval. Use Caution/Monitor.

            • sevelamer

              sevelamer decreases levels of flecainide by increasing elimination. Use Caution/Monitor.

            • sodium bicarbonate

              sodium bicarbonate will increase the level or effect of flecainide by passive renal tubular reabsorption - basic urine. Use Caution/Monitor.

            • sodium citrate/citric acid

              sodium citrate/citric acid will increase the level or effect of flecainide by passive renal tubular reabsorption - basic urine. Use Caution/Monitor.

            • sodium lactate

              sodium lactate will increase the level or effect of flecainide by passive renal tubular reabsorption - basic urine. Use Caution/Monitor.

            • sorafenib

              sorafenib and flecainide both increase QTc interval. Use Caution/Monitor.

            • sulfamethoxazole

              sulfamethoxazole and flecainide both increase QTc interval. Use Caution/Monitor.

            • teduglutide

              teduglutide increases levels of flecainide by Other (see comment). Use Caution/Monitor. Comment: Teduglutide may increase absorption of concomitant PO medications; caution with with drugs requiring titration or those with a narrow therapeutic index; dose adjustment may be necessary.

            • telavancin

              flecainide and telavancin both increase QTc interval. Use Caution/Monitor.

            • terbinafine

              terbinafine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Modify Therapy/Monitor Closely. Assess need to reduce dose of CYP2D6-metabolized drug.

            • thioridazine

              thioridazine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              thioridazine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • trazodone

              trazodone and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • trifluoperazine

              trifluoperazine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • trimethoprim

              flecainide and trimethoprim both increase QTc interval. Use Caution/Monitor.

            • trimipramine

              trimipramine and flecainide both increase QTc interval. Modify Therapy/Monitor Closely.

            • triptorelin

              triptorelin increases toxicity of flecainide by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • tropisetron

              flecainide and tropisetron both increase QTc interval. Use Caution/Monitor.

            • venlafaxine

              venlafaxine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Use Caution/Monitor.

              flecainide and venlafaxine both increase QTc interval. Use Caution/Monitor.

            • voclosporin

              voclosporin, flecainide. Either increases effects of the other by QTc interval. Use Caution/Monitor.

            • voriconazole

              flecainide and voriconazole both increase QTc interval. Use Caution/Monitor.

            • ziprasidone

              flecainide and ziprasidone both increase QTc interval. Modify Therapy/Monitor Closely.

            Minor (6)

            • apomorphine

              apomorphine and flecainide both increase QTc interval. Minor/Significance Unknown.

            • azithromycin

              azithromycin and flecainide both increase QTc interval. Minor/Significance Unknown.

            • duloxetine

              duloxetine will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown.

            • lily of the valley

              flecainide, lily of the valley. Either increases toxicity of the other by pharmacodynamic synergism. Minor/Significance Unknown.

            • pazopanib

              flecainide and pazopanib both increase QTc interval. Minor/Significance Unknown.

            • sertraline

              sertraline will increase the level or effect of flecainide by affecting hepatic enzyme CYP2D6 metabolism. Minor/Significance Unknown. Monitor the EKG in patients receiving concurrent flecainide and sertraline. Doses of flecainide may need to be reduced.

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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 electrolyte imbalances, especially hypomagnesemia or hypokalemia before initiating therapy

            May cause visual disturbances

            Flecainide may depress LV function significantly with preexisting LV dysfunction

            Flecainide should be avoided in patients with HF or structural heart disease

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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.

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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

            Note: Elimination is much slower with highly alkaline urine (pH >8), which may occur in rare conditions (eg, renal tubular acidosis, strict vegetarian diet)

            Excretion: Urine (80-90%); feces (minor)

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            Administration

            Oral Administration

            May take with food

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            flecainide oral
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            flecainide oral
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            100 mg tablet
            flecainide oral
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            flecainide oral
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            flecainide oral
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            flecainide oral
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            flecainide oral
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            flecainide oral
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            100 mg tablet
            flecainide oral
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            flecainide oral
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            flecainide oral
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            150 mg tablet
            flecainide oral
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            100 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            flecainide oral

            FLECAINIDE - ORAL

            (fleck-UH-nide)

            COMMON BRAND NAME(S): Tambocor

            WARNING: Though this medication often gives great benefits to people with irregular heartbeat, it may rarely cause a serious new irregular heartbeat. When starting treatment with this drug, your doctor may recommend that you stay in the hospital for proper monitoring. Flecainide should not be used to treat a certain type of irregular heartbeat (persistent atrial fibrillation/flutter). Talk with your doctor about the benefits and risks of taking this medication for your condition.

            USES: This medication is used to treat certain types of serious (possibly fatal) irregular heartbeat (such as persistent ventricular tachycardia and paroxysmal supraventricular tachycardia). It is used to restore normal heart rhythm and maintain a regular, steady heartbeat. It is also used to prevent certain types of irregular heartbeat from returning (such as atrial fibrillation). Flecainide is known as an anti-arrhythmic drug. It works by blocking certain electrical signals in the heart that can cause an irregular heartbeat. Treating an irregular heartbeat can decrease the risk for blood clots, and this effect can reduce your risk of heart attack or stroke.Older adults should discuss the risks and benefits of this medication with their doctor or pharmacist, as well as other effective and possibly safer treatments.

            HOW TO USE: Take this medication by mouth with or without food, usually twice daily or as directed by your doctor.The dosage is based on your age, medical condition, response to treatment, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Tell your doctor if your condition does not improve or if it worsens.

            SIDE EFFECTS: See also Warning section.Dizziness, vision problems (such as blurred vision, problems focusing, seeing spots), headache, nausea, shaking, tiredness, or weakness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: new or worsening symptoms of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain).Get medical help right away if you have any very serious side effects, including: faster/more irregular heartbeat, severe dizziness, fainting.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking flecainide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, liver problems, other heart problems (such as previous heart attack, heart pacemaker).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Flecainide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using flecainide, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using flecainide safely.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk. However, this drug is unlikely to harm a nursing infant. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Many drugs besides flecainide may affect the heart rhythm (QT prolongation), including amiodarone, dofetilide, pimozide, procainamide, quinidine, sotalol, and macrolide antibiotics (such as erythromycin), among others.Other medications can affect the removal of flecainide from your body, which may affect how flecainide works. Examples include asunaprevir, cimetidine, fluconazole, certain HIV protease inhibitors (such as ritonavir, tipranavir), anti-seizure drugs (such as phenytoin, phenobarbital), among others.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe nausea/vomiting, seizures, very slow heartbeat, severe dizziness, fainting.

            NOTES: Do not share this medication with others.Laboratory and/or medical tests (such as EKG) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            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.
            • Manage and view all your plans together – even plans in different states.
            • 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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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.